Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06593288
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
Randomized Clinical Trial of Spontaneous Breathing Test
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Randomized Clinical Trial of Spontaneous Breathing Test
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Our hypothesis is that the Spontaneous Breathing Test SBT without pressure support PS is not inferior to the SBT with pressure support in relation to the following outcomes a extubation failure b time on MV
The main objective of this study is to determine whether SBT without PS is non-inferior to SBT with PS in relation to the primary outcome a extubation failure and secondary outcomes b length of stay in the PICU and c days free of MV
Pacients will be randomized to 2 arms
1 SBT with PS
2 SBT without PS with PEEP only
The main objective of this study is to determine whether SBT without PS is non-inferior to SBT with PS in relation to the primary outcome a extubation failure and secondary outcomes b length of stay in the PICU and c days free of MV
Pacients will be randomized to 2 arms
1 SBT with PS
2 SBT without PS with PEEP only
Detailed Description:
Introduction Mechanical ventilation MV is a common procedure for patients admitted to pediatric intensive care units PICUs Although MV is often necessary and life-saving it can be associated with complications such as ventilator-associated pneumonia cardiovascular dysfunction airway injury and patient immobility The longer the duration of MV the greater the risk of morbidity length of stay and mortality To reduce the risks associated with prolonged MV clinicians should seek to continually optimize the process of weaning from ventilation WVL thereby increasing the likelihood of successful extubation WVL is defined as the gradual reduction of mechanical ventilatory support and the transfer of respiratory control and the work of breathing back to the patient Traditionally WVL was conducted through clinical judgment and a personal decision Only in recent years have protocol-based approaches been implemented with conflicting results although most studies show that a protocolized approach tends to reduce the duration of mechanical ventilation Extubation is defined as removal of the endotracheal tube and extubation failure occurs when a patient requires reintubation within hours or days of a planned extubation More recently extubation failure has been considered as reintubation within 48 hours of a planned extubation Extubation failure may be secondary to the inability to maintain alveolar oxygenation andor ventilation airway patency and protection secretion control or any combination of these Extubation failure occurs in 3-22 of patients regardless of the severity of the underlying disease with evidence that its occurrence can directly worsen patient outcomes including an increased mortality rate Various clinical approaches are used to decide the best timing for extubation ranging from the use of tools such as chest and diaphragm ultrasound to readiness testing and spontaneous breathing but there is no clear evidence on which technique is best in children
Rationale
When using MV it is important to critically balance the minimization of procedural risks against the risks of extubation failure EF and its association with morbidities The International Guidelines for Liberation from Mechanical Ventilation in Pediatrics were published in 2022 with the aim of guiding best practices for liberation from MV2 Experts have given their opinions on the various aspects of liberation from MV Among several definitions the most important for this study are
Extubation readiness test ERT 957 agreement It is a set of elements bundle that are used to assess the patient39s eligibility to be liberated from invasive MV IMV In addition to the usual ERT components such as values of the fraction of inspired oxygen FiO2 positive end-expiratory pressure PEEP the factor that led to tracheal intubation in resolution ERT may include factors such as assessment of the level of sedation neurological adequacy of airway control coughing and choking probability of upper airway obstruction after extubation assessment of respiratory muscle strength magnitude of airway secretions hemodynamic status and planning of respiratory support after extubation Spontaneous breathing trial SBT 913 agreement Systematic method of reducing IMV support to predetermined parameters to assess the likelihood that the patient will be able to independently maintain minute ventilation and gas exchange without excessive respiratory effort if released from IMV
Among the recommendations of the guidelines we have
Recommendation 1 A protocolized assessment was suggested to assess eligibility for SBT 100 agreement - Notes SBT should be conducted at regular intervals to identify when the patient has met pre-established parameters to conduct safe extubation
Recommendation 2 The protocolized use of the SBT bundle was suggested compared to the clinical assessment of readiness for extubation 88 agreement - Notes The EBT bundle includes elements that are used to assess whether the patient is ready to be released from IMV In addition to the SBT it may include factors such as assessment of sedation adequacy of neurological control of the airway coughing and choking likelihood of upper airway obstruction assessment of respiratory muscle strength magnitude of airway secretions hemodynamic status and planning of respiratory support after extubation
Recommendation 3 It was suggested that the SBT be performed as part of the EBT bundle to objectively assess whether the patient is able to independently maintain adequate minute ventilation and gas exchange without excessive respiratory effort if released from IMV 96 agreement
Recommendation 4 It was suggested that pressure support PS be increased with CPAP or CPAP alone during the SBT in mechanically ventilated children at standard risk of extubation failure Conditional recommendation with very low level of evidence
Recommendation 5 For children at high risk of extubation failure Table 1 it was suggested to use CPAP without increasing PS during SBT to better assess readiness for extubation Conditional recommendation with very low level of evidence
Since the levels of evidence are low on how to perform SBT with or without PS there is a knowledge gap In clinical practice studies show the use of SBT with PS by most clinicians Khemani et al advocate that SBT should be performed without pressure support Ferguson et al in a study of 755 extubations concluded that an SBT using pressure support set at higher levels for smaller endotracheal tubes overestimates readiness for extubation in children and contributes to a higher rate of unsuccessful extubation
Hypothesis Our hypothesis is that the Spontaneous Breathing Trial without pressure support is not inferior to the Spontaneous Breathing Trial with pressure support in relation to the following outcomes a extubation failure b time on MV
General Objective The main objective of this study is to determine whether the SBT without PS is not inferior to the SBT with PS in relation to the primary outcome a extubation failure and secondary outcomes b length of stay in the PICU and c days free of MV DLMV
Study DesignMethodology The study will be multicenter randomized open-label prospective with two arms The study will be submitted to the Research Ethics Committee of all centers and authorization will be requested from the patient39s parents or legal guardians by signing the informed consent form ICF The study will be registered on Clinicaltrialsgov and will follow the CONSORT 2010 guidelines Patients admitted to participating PICUs receiving IMV for more than 24 hours will be screened twice a day between 700 and 900 am between 200 and 400 pm in the afternoon for the Extubation Readiness Test EBT and if they pass will proceed to the Spontaneous Breathing Trial SBT lasting one hour
Inclusion criteria
Patients admitted to the PICU on IMV for more than 24 hours
Patients over 1 month of age corrected gestational age gt 38 weeks and lt 18 years old on the day of screening for ERT
Exclusion criteria
Perinatal-related lung disease
Congenital diaphragmatic hernia or congenitalacquired paralysis of the diaphragm
Children with heart disease
Primary pulmonary hypertension
Bronchiolitis obliterans
Post-hematopoietic stem cell transplant specifically patients receiving continuous supplemental oxygen for three or more days prior to intubation receiving noninvasive ventilation for more than 24 hours prior to intubation receiving more than one vasoactive medication at the time of meeting the inclusion criteria spending more than four days in the PICU prior to intubation supported on or with immediate plans for renal replacement therapies with two or more allogeneic transplants who relapsed after transplant or with diffuse alveolar hemorrhage
Post-lung transplantation
Home ventilator dependence with baseline Oxygen Saturation Index OSI gt6 baseline is defined as a stable period prior to the present illness
Neuromuscular respiratory failure
Critical airway obstruction eg post-laryngotracheal surgery or new tracheostomy or anatomical lower airway obstruction eg mediastinal mass
Facial surgery or trauma in the past two weeks
Intracranial bleeding
Morbid obesity 2w-24mo WHO weight-for-length z-scoreheight z-score 3 2y WHO body mass index BMI-for-age z-score 3
Familymedical team unsupportive total patient treatment considered futile
Previously enrolled in a current study
Enrolled in any other clinical trial with intervention not approved for concomitant enrollment
Pregnancy
Extubation Readiness Test This is a standardized test to determine whether the patient is ready to be extubated from a pulmonary perspective The test should not be initiated if
There is no neurological responsiveness and the ability to protect the airway is altered
Inaudible air leak around an uncuffeddeflated COT
Scheduled procedure requiring deep sedationanesthesia eg MRI surgery etc
Patients who meet the following prerequisites will be considered eligible for extubation
Spontaneous breathing
IOISO 6
Reduction andor stabilization of ventilator support in the last 12 hours
In this case we proceed to the checklist yesno
Cause of intubation in resolution
Cardiovascular stabilityvasoactive drugs in reductiondiscontinued
May have altered creatinine but must be urinatingwithout fluid overload - No excess secretions 22
No change in level of consciousness and no respiratory effort
MV parameters FIO2lt50 PEEP8 PIPlt25 If all the above requirements are met the patient will be able to undergo SBT SBT may be postponed by the attending physician even if all prerequisites are met if heshe believes that the patient is not clinically well or has an upcoming procedure to be performed while intubated eg Magnetic Resonance Imaging
Patients who passed the TPE and are able to undergo SBT will be randomized to
Arm 1 SBT 1 hour with PEEP and without PS The patient should remain with the same PEEP and FiO2 as during the TPE
Arm 2 SBT 1 hour with PEEP and with PS The patient should remain with the same PEEP and FiO2 as during the TPE The PS will be adjusted according to the diameter of the tracheal tube
PS 6cmH2O for TOT gt 5mm PS 8cmH2O for TOT 4 - 5mm PS 10cmH2O for TOT 35mm
The following parameters must be monitored and recorded on a form Appendix I HR RR SatO2 respiratory effort at times zero five ten twenty thirty forty-five and sixty minutes
The SBT will be considered failed if
There is a drop in SatO2 lt92 maintained for 5 minutes
Increase in RR maintained for 5 minutes above normal for age
Increase in HR maintained for 5 minutes above normal for age
Increase in respiratory effort maintained for 5 minutes consensus between physiotherapist and attending physician Otherwise the SBT will be considered positive and the patient must progress to tracheal extubation
If the patient passes the SBT and does not progress to tracheal extubation the reason must be stated on the study form
After tracheal extubation
May extubate to a higher FiO2 than on the ventilator and then reduce FiO2 every 2 hours to maintain SpO294
If the patient develops respiratory distress after extubation
If stridor is present consider IV dexamethasone epinephrine inhalation Q15 min
If stridor is not present consider NIV or LEEP
Extubation failure Early extubation failure will be defined as the participant being reintubated within 48 hours after the planned tracheal extubation
Randomization When patients meet the study inclusion criteria the informed consent form will be applied to parentsguardians
Once the informed consent form has been signed randomization will be carried out using the REDCap tool
Statistical Analysis Descriptive data will be expressed as frequencies The distribution of each continuous variable will be described by medians and interquartile ranges IQRs The Mann-Whitney U test and the Chi-Square test or Fisher39s exact test will be used to compare continuous and nominal variables respectively The Kruskal-Wallis test will be used to compare continuous variables between more than two groups
Sample size calculation
The null hypothesis to be tested is that the percentage of successful extubation for patients on pressure support is better than the percentage for those on CPAP above a tolerance value of 10 or 15 delta or non-inferiority limit
H0 πps πcpap d where πs percentage of successful extubation on pressure support πcpap percentage of successful extubation on CPAP d delta tolerance 10 or 15 By rejecting H0 we accept the alternative hypothesis that the percentage for those on CPAP is πs - d H1 πps - d lt πcpap
Therefore by accepting H1 we confirm that CPAP is not inferior to pressure support within the margin of tolerance
In the study by Ferguson et al 755 extubation readiness tests were performed on 538 patients using pressure support 58 required reintubation success rate of 94216 Using the success rates from this study for our sample size calculation 94 patients will be needed in each group 188 patients for both arms to show with 90 power 1-beta that the upper limit of a two-sided 90 confidence interval or 95 of a one-sided CI will exclude a difference in favor of the Pressure Support group for a delta of 10
42 patients will be needed in each group 84 patients for both arms for a delta of 15 and a power of 90
For a power of 80 and a delta of 10 68 patients will be needed in each group 136 patients for both arms For a power of 80 and a delta of 15 31 patients will be needed in each group 62 patients for both arms
Considering an estimated loss of 20 of the sample due to various causes medical record problems participant withdrawals and unforeseen causes considering a power of 80 and a delta of 10 we expect to recruit 170 patients in both arms of the study
To determine non-inferiority we will use the Farrington-Manning test from the DescrTab2 package of R A language and environment for statistical computing R Foundation for Statistical Computing Vienna
Study Location A multicenter study with the Hospital das Clínicas of the Ribeirão Preto Medical School of the University of São Paulo FMRP-USP as the proposing institution The other participating centers will be invited to join the study through an invitation made by the Brazilian Research Network in Pediatric Intensive Care Brnet-PIC to reach the required sample size
Ethical Issues A free and informed consent form FICF will be applied to the research participants signed by a parent or guardian during the study For participants over 6 years of age the free and informed consent form FICF will also be applied which may be applied later since the patients will be sedated and on MV during randomization
Risks and benefits Risks although unlikely there may be risks related to the breach of data confidentiality However the researchers will undertake to take all possible measures to maintain the confidentiality of the data of the study subjects Confidentiality will be maintained by the anonymity of the questionnaire and by the division of hospitals by region of the country and not by their name or specific geographic location In principle choosing a support mode in a given arm of the study over the other arm does not imply any risk to the patient
Benefits the results of this study will not bring a direct benefit to the study participants but may bring benefits in expanding knowledge regarding best practices for safe extubation of future patients
Data Management and Protection Data will be collected through electronic forms from REDCap Research Electronic Data Capture Vanderbilt USA and participants will have their data de-identified Data storage will be handled by the University of São Paulo and protected by an encrypted password Digital forms will be deleted from any data source after a regulatory period of five years
Rationale
When using MV it is important to critically balance the minimization of procedural risks against the risks of extubation failure EF and its association with morbidities The International Guidelines for Liberation from Mechanical Ventilation in Pediatrics were published in 2022 with the aim of guiding best practices for liberation from MV2 Experts have given their opinions on the various aspects of liberation from MV Among several definitions the most important for this study are
Extubation readiness test ERT 957 agreement It is a set of elements bundle that are used to assess the patient39s eligibility to be liberated from invasive MV IMV In addition to the usual ERT components such as values of the fraction of inspired oxygen FiO2 positive end-expiratory pressure PEEP the factor that led to tracheal intubation in resolution ERT may include factors such as assessment of the level of sedation neurological adequacy of airway control coughing and choking probability of upper airway obstruction after extubation assessment of respiratory muscle strength magnitude of airway secretions hemodynamic status and planning of respiratory support after extubation Spontaneous breathing trial SBT 913 agreement Systematic method of reducing IMV support to predetermined parameters to assess the likelihood that the patient will be able to independently maintain minute ventilation and gas exchange without excessive respiratory effort if released from IMV
Among the recommendations of the guidelines we have
Recommendation 1 A protocolized assessment was suggested to assess eligibility for SBT 100 agreement - Notes SBT should be conducted at regular intervals to identify when the patient has met pre-established parameters to conduct safe extubation
Recommendation 2 The protocolized use of the SBT bundle was suggested compared to the clinical assessment of readiness for extubation 88 agreement - Notes The EBT bundle includes elements that are used to assess whether the patient is ready to be released from IMV In addition to the SBT it may include factors such as assessment of sedation adequacy of neurological control of the airway coughing and choking likelihood of upper airway obstruction assessment of respiratory muscle strength magnitude of airway secretions hemodynamic status and planning of respiratory support after extubation
Recommendation 3 It was suggested that the SBT be performed as part of the EBT bundle to objectively assess whether the patient is able to independently maintain adequate minute ventilation and gas exchange without excessive respiratory effort if released from IMV 96 agreement
Recommendation 4 It was suggested that pressure support PS be increased with CPAP or CPAP alone during the SBT in mechanically ventilated children at standard risk of extubation failure Conditional recommendation with very low level of evidence
Recommendation 5 For children at high risk of extubation failure Table 1 it was suggested to use CPAP without increasing PS during SBT to better assess readiness for extubation Conditional recommendation with very low level of evidence
Since the levels of evidence are low on how to perform SBT with or without PS there is a knowledge gap In clinical practice studies show the use of SBT with PS by most clinicians Khemani et al advocate that SBT should be performed without pressure support Ferguson et al in a study of 755 extubations concluded that an SBT using pressure support set at higher levels for smaller endotracheal tubes overestimates readiness for extubation in children and contributes to a higher rate of unsuccessful extubation
Hypothesis Our hypothesis is that the Spontaneous Breathing Trial without pressure support is not inferior to the Spontaneous Breathing Trial with pressure support in relation to the following outcomes a extubation failure b time on MV
General Objective The main objective of this study is to determine whether the SBT without PS is not inferior to the SBT with PS in relation to the primary outcome a extubation failure and secondary outcomes b length of stay in the PICU and c days free of MV DLMV
Study DesignMethodology The study will be multicenter randomized open-label prospective with two arms The study will be submitted to the Research Ethics Committee of all centers and authorization will be requested from the patient39s parents or legal guardians by signing the informed consent form ICF The study will be registered on Clinicaltrialsgov and will follow the CONSORT 2010 guidelines Patients admitted to participating PICUs receiving IMV for more than 24 hours will be screened twice a day between 700 and 900 am between 200 and 400 pm in the afternoon for the Extubation Readiness Test EBT and if they pass will proceed to the Spontaneous Breathing Trial SBT lasting one hour
Inclusion criteria
Patients admitted to the PICU on IMV for more than 24 hours
Patients over 1 month of age corrected gestational age gt 38 weeks and lt 18 years old on the day of screening for ERT
Exclusion criteria
Perinatal-related lung disease
Congenital diaphragmatic hernia or congenitalacquired paralysis of the diaphragm
Children with heart disease
Primary pulmonary hypertension
Bronchiolitis obliterans
Post-hematopoietic stem cell transplant specifically patients receiving continuous supplemental oxygen for three or more days prior to intubation receiving noninvasive ventilation for more than 24 hours prior to intubation receiving more than one vasoactive medication at the time of meeting the inclusion criteria spending more than four days in the PICU prior to intubation supported on or with immediate plans for renal replacement therapies with two or more allogeneic transplants who relapsed after transplant or with diffuse alveolar hemorrhage
Post-lung transplantation
Home ventilator dependence with baseline Oxygen Saturation Index OSI gt6 baseline is defined as a stable period prior to the present illness
Neuromuscular respiratory failure
Critical airway obstruction eg post-laryngotracheal surgery or new tracheostomy or anatomical lower airway obstruction eg mediastinal mass
Facial surgery or trauma in the past two weeks
Intracranial bleeding
Morbid obesity 2w-24mo WHO weight-for-length z-scoreheight z-score 3 2y WHO body mass index BMI-for-age z-score 3
Familymedical team unsupportive total patient treatment considered futile
Previously enrolled in a current study
Enrolled in any other clinical trial with intervention not approved for concomitant enrollment
Pregnancy
Extubation Readiness Test This is a standardized test to determine whether the patient is ready to be extubated from a pulmonary perspective The test should not be initiated if
There is no neurological responsiveness and the ability to protect the airway is altered
Inaudible air leak around an uncuffeddeflated COT
Scheduled procedure requiring deep sedationanesthesia eg MRI surgery etc
Patients who meet the following prerequisites will be considered eligible for extubation
Spontaneous breathing
IOISO 6
Reduction andor stabilization of ventilator support in the last 12 hours
In this case we proceed to the checklist yesno
Cause of intubation in resolution
Cardiovascular stabilityvasoactive drugs in reductiondiscontinued
May have altered creatinine but must be urinatingwithout fluid overload - No excess secretions 22
No change in level of consciousness and no respiratory effort
MV parameters FIO2lt50 PEEP8 PIPlt25 If all the above requirements are met the patient will be able to undergo SBT SBT may be postponed by the attending physician even if all prerequisites are met if heshe believes that the patient is not clinically well or has an upcoming procedure to be performed while intubated eg Magnetic Resonance Imaging
Patients who passed the TPE and are able to undergo SBT will be randomized to
Arm 1 SBT 1 hour with PEEP and without PS The patient should remain with the same PEEP and FiO2 as during the TPE
Arm 2 SBT 1 hour with PEEP and with PS The patient should remain with the same PEEP and FiO2 as during the TPE The PS will be adjusted according to the diameter of the tracheal tube
PS 6cmH2O for TOT gt 5mm PS 8cmH2O for TOT 4 - 5mm PS 10cmH2O for TOT 35mm
The following parameters must be monitored and recorded on a form Appendix I HR RR SatO2 respiratory effort at times zero five ten twenty thirty forty-five and sixty minutes
The SBT will be considered failed if
There is a drop in SatO2 lt92 maintained for 5 minutes
Increase in RR maintained for 5 minutes above normal for age
Increase in HR maintained for 5 minutes above normal for age
Increase in respiratory effort maintained for 5 minutes consensus between physiotherapist and attending physician Otherwise the SBT will be considered positive and the patient must progress to tracheal extubation
If the patient passes the SBT and does not progress to tracheal extubation the reason must be stated on the study form
After tracheal extubation
May extubate to a higher FiO2 than on the ventilator and then reduce FiO2 every 2 hours to maintain SpO294
If the patient develops respiratory distress after extubation
If stridor is present consider IV dexamethasone epinephrine inhalation Q15 min
If stridor is not present consider NIV or LEEP
Extubation failure Early extubation failure will be defined as the participant being reintubated within 48 hours after the planned tracheal extubation
Randomization When patients meet the study inclusion criteria the informed consent form will be applied to parentsguardians
Once the informed consent form has been signed randomization will be carried out using the REDCap tool
Statistical Analysis Descriptive data will be expressed as frequencies The distribution of each continuous variable will be described by medians and interquartile ranges IQRs The Mann-Whitney U test and the Chi-Square test or Fisher39s exact test will be used to compare continuous and nominal variables respectively The Kruskal-Wallis test will be used to compare continuous variables between more than two groups
Sample size calculation
The null hypothesis to be tested is that the percentage of successful extubation for patients on pressure support is better than the percentage for those on CPAP above a tolerance value of 10 or 15 delta or non-inferiority limit
H0 πps πcpap d where πs percentage of successful extubation on pressure support πcpap percentage of successful extubation on CPAP d delta tolerance 10 or 15 By rejecting H0 we accept the alternative hypothesis that the percentage for those on CPAP is πs - d H1 πps - d lt πcpap
Therefore by accepting H1 we confirm that CPAP is not inferior to pressure support within the margin of tolerance
In the study by Ferguson et al 755 extubation readiness tests were performed on 538 patients using pressure support 58 required reintubation success rate of 94216 Using the success rates from this study for our sample size calculation 94 patients will be needed in each group 188 patients for both arms to show with 90 power 1-beta that the upper limit of a two-sided 90 confidence interval or 95 of a one-sided CI will exclude a difference in favor of the Pressure Support group for a delta of 10
42 patients will be needed in each group 84 patients for both arms for a delta of 15 and a power of 90
For a power of 80 and a delta of 10 68 patients will be needed in each group 136 patients for both arms For a power of 80 and a delta of 15 31 patients will be needed in each group 62 patients for both arms
Considering an estimated loss of 20 of the sample due to various causes medical record problems participant withdrawals and unforeseen causes considering a power of 80 and a delta of 10 we expect to recruit 170 patients in both arms of the study
To determine non-inferiority we will use the Farrington-Manning test from the DescrTab2 package of R A language and environment for statistical computing R Foundation for Statistical Computing Vienna
Study Location A multicenter study with the Hospital das Clínicas of the Ribeirão Preto Medical School of the University of São Paulo FMRP-USP as the proposing institution The other participating centers will be invited to join the study through an invitation made by the Brazilian Research Network in Pediatric Intensive Care Brnet-PIC to reach the required sample size
Ethical Issues A free and informed consent form FICF will be applied to the research participants signed by a parent or guardian during the study For participants over 6 years of age the free and informed consent form FICF will also be applied which may be applied later since the patients will be sedated and on MV during randomization
Risks and benefits Risks although unlikely there may be risks related to the breach of data confidentiality However the researchers will undertake to take all possible measures to maintain the confidentiality of the data of the study subjects Confidentiality will be maintained by the anonymity of the questionnaire and by the division of hospitals by region of the country and not by their name or specific geographic location In principle choosing a support mode in a given arm of the study over the other arm does not imply any risk to the patient
Benefits the results of this study will not bring a direct benefit to the study participants but may bring benefits in expanding knowledge regarding best practices for safe extubation of future patients
Data Management and Protection Data will be collected through electronic forms from REDCap Research Electronic Data Capture Vanderbilt USA and participants will have their data de-identified Data storage will be handled by the University of São Paulo and protected by an encrypted password Digital forms will be deleted from any data source after a regulatory period of five years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None