Ignite Creation Date:
2024-10-25 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06583824
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-02
Brief Title:
Incidence and Complications of Post-extubation and Post-tracheostomy Dysphagia in Adult Patients in the Critical Care Unit
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Incidence and Complications Associated with Acquired Swallowing Disorder in the Intensive Care Unit in Extubated or Tracheotomized Patients a Cohort Study
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:
Acquired Swallowing Disorder in ICU ICU-ASD also known as postextubation dysphagia is a multicausal problem experienced by survivors in intensive care units ICUs when the efficiency safety of swallowing or both are compromised These alterations can lead to an increased risk of aspiration respiratory complications and malnutrition potentially resulting in prolonged hospitalization reduced quality of life poorer clinical outcomes and even death
Despite the clinical and social significance of this disorder there is limited research addressing it Existing studies primarily focus on incidence and associated factors with scant attention to the occurrence of complications and there is a lack of assessment of the quality of life of these patients In our context healthcare professionals are increasingly recognizing the importance of this issue although the real incidence of ICU-ASD as well as the frequency of respiratory and nutritional complications remains unknown Furthermore the quality of life of patients with this disorder has not been evaluated thus far
ObjectivesPrimary To analyze the occurrence of respiratory and nutritional complications associated with ICU-ASD in patients intubated for 48 hours or tracheotomized in the Intensive Care Unit of the University Hospital Complex of Albacete ICU CHUA and identify potential factors related to their occurrence
Specific To determine the incidence of ICU-ASD in the polyvalent ICU CHUA assess the frequency of respiratory complications evaluate nutritional status assess quality of life and determine the mortality of study participants
Material and Method Prospective observational cohort study Setting Polyvalent ICU CHUA Participants Intubated patients for 48 hours or tracheotomized with signed consent Sampling Consecutive Sample size 414 participants Demographicclinical variables Outcome variables Occurrence of respiratory complications nutritional status quality of life Instruments Modified Volume-Viscosity Swallowing Test mV-VST Swallowing Quality of Life Questionnaire SWAL-QoL Dysphagia detection will occur 24 hours post-extubation andor 4 days after tracheotomy Follow-up during hospitalization and post-ICU discharge until the outpatient consultation Statistical analysis Absolute and relative frequencies measures of central tendency and dispersion significance level of p ampamplt 005 95 CI Bivariate analysis Checking group homogeneity and hypothesis testing Chi-square Studentampamp39s t-test U-Mann-Whitney ANOVA or Kruskal-Wallis
Despite the clinical and social significance of this disorder there is limited research addressing it Existing studies primarily focus on incidence and associated factors with scant attention to the occurrence of complications and there is a lack of assessment of the quality of life of these patients In our context healthcare professionals are increasingly recognizing the importance of this issue although the real incidence of ICU-ASD as well as the frequency of respiratory and nutritional complications remains unknown Furthermore the quality of life of patients with this disorder has not been evaluated thus far
ObjectivesPrimary To analyze the occurrence of respiratory and nutritional complications associated with ICU-ASD in patients intubated for 48 hours or tracheotomized in the Intensive Care Unit of the University Hospital Complex of Albacete ICU CHUA and identify potential factors related to their occurrence
Specific To determine the incidence of ICU-ASD in the polyvalent ICU CHUA assess the frequency of respiratory complications evaluate nutritional status assess quality of life and determine the mortality of study participants
Material and Method Prospective observational cohort study Setting Polyvalent ICU CHUA Participants Intubated patients for 48 hours or tracheotomized with signed consent Sampling Consecutive Sample size 414 participants Demographicclinical variables Outcome variables Occurrence of respiratory complications nutritional status quality of life Instruments Modified Volume-Viscosity Swallowing Test mV-VST Swallowing Quality of Life Questionnaire SWAL-QoL Dysphagia detection will occur 24 hours post-extubation andor 4 days after tracheotomy Follow-up during hospitalization and post-ICU discharge until the outpatient consultation Statistical analysis Absolute and relative frequencies measures of central tendency and dispersion significance level of p ampamplt 005 95 CI Bivariate analysis Checking group homogeneity and hypothesis testing Chi-square Studentampamp39s t-test U-Mann-Whitney ANOVA or Kruskal-Wallis
Detailed Description:
Hypothesis Patients with ICU-Acquired Swallowing Disorder ICU-ASD have a higher frequency of respiratory complications and poorer nutritional status compared to patients without dysphagia
Objectives
Primary Objective To analyze the occurrence of respiratory and nutritional complications associated with ICU-Acquired Swallowing Disorder ICU-ASD in patients intubated for more than 48 hours or tracheostomized in the multidisciplinary ICU at CHUA and to explore potential factors related to their occurrence
Secondary Objectives
To determine the incidence of ICU-ASD in the multidisciplinary ICU at CHUA To determine the frequency of respiratory complications in post-extubated and tracheostomized patients in the multidisciplinary ICU at CHUA
To assess the nutritional status of post-extubated and tracheostomized patients in the multidisciplinary ICU at CHUA
To evaluate the quality of life with dysphagia in patients who developed ICU-ASD after hospital discharge
To determine the mortality rate of post-extubated and tracheostomized patients in the ICU at CHUA
SAMPLE SIZE Since there is no existing data on complications caused by dysphagia in our unit we have considered the study by McIntyre et al 2022 which shows an incidence of pneumonia of 21 in patients with ICU-ASD and 9 in extubated patients without dysphagia OR251 95 CI 127-495 Based on these premises the sample size was calculated using the Epiinfo program estimating a 95 confidence interval CI 80 power and a 11 group ratio We obtain a sample of 360 participants adding 15 for potential losses which means an additional 54 patients The final sample size to be achieved is 414 participants Participants will be selected through consecutive sampling meeting inclusion criteria and always with signed consent after verbal information and delivery of the information sheet According to statistical data from the CHUA ICU from previous years achieving this sample will likely take two years
RECRUITMENT PERIOD September 2024-September 2026 2 years STUDY COMPLETION Completion of the study until the end of follow-up death or withdrawal of informed consent
VARIABLES AND MEASUREMENT INSTRUMENTS
Age difference between date of birth and admission date Collected from the medical record
Sex malefemale As recorded in the medical record Comorbidities personal history of disease Collected from the medical record Categorized admission diagnosis cardiovascular respiratory gastrointestinal neurological trauma metabolic hematological urological intoxications and others These may be later analyzed as two groups NEUROCRITICALNON-NEUROCRITICAL
Presence of NG tube and number of days Number and type Levin Flekka nasojejunal Collected from the patientamp39s daily ICU chart
Endotracheal tube used number and type subglotticnon-subglottic Collected from the vital signs chart
Tracheostomy technique used for insertion PERCUTANEOUSSURGICAL cannula number and type with cuffwithout cuff Collected from the patientamp39s vital signs chart
Days of pre-ICU admission ICU admission date - hospital admission date Collected from the medical record
Days of ICU admission date of transfer to the ward or death - ICU admission date Collected from the medical record
Days of post-ICU admission from transfer to the ward until discharge Collected from the medical record
Total hospital stay day of discharge - day of admission Collected from the medical record
Days with invasive mechanical ventilation IMV Collected from the ICU vital signs chart
Days with endotracheal tube ETT Collected from the ICU vital signs chart Days with tracheostomy Collected from the ICU vital signs chart Discharge destination homehealthcare facility Collected from the medical record at the time of nursing discharge
Patient severity in ICU using the Acute Physiology And Chronic Health Evaluation APACHE II Collected from the patientamp39s medical record
Sequential Organ Failure Assessment SOFA Collected from the patientamp39s medical record
Nutritional parameters
Body Mass Index BMI We will collect weight and height referring to the baseline state Weight measurement when oral feeding begins the patient will be weighed on a chair or bed scale Upon transfer to the ward chair scale At one month and three months in the post-ICU clinic Height measurement the first time it is possible to measure with a stadiometer
Biochemical parameters prealbumin cholesterol and C-reactive protein CRP Collected from the medical record The week the swallowing test is performed the day of transfer to the ward at discharge and at 30 days in the clinic
Existence of ICU-ASD determined using the mV-VST13 To perform the test the patient must have an adequate level of consciousness RASS 0 and CAM-ICU negative The test will always be performed before starting oral intake If positive indicating ICU-ASD it will be repeated weekly in the ward each week while positive If it remains positive it will be followed up in the endocrinology clinic so data from their assessments will be collected
Respiratory complications
Respiratory infections We collect diagnoses of TRACHEOBRONCHITIS and PNEUMONIA described in the medical record The diagnosis can occur throughout the follow-up including visits to the health center and emergency services Record the date from the medical record
Bronchoaspiration Described in the medical record as confirmed or suspected Bronchoaspiration yesno and the date it occurs
Reintubation yesno Number of times Collected from the ICU vital signs chart Hospital readmissions due to swallowing disorder complications As described in the admission note Collected from the computerized medical record
Emergency visits due to swallowing disorder complications Collected from the computerized medical record
Quality of life using the Swallowing Quality of Life Questionnaire for adults SWAL-QoL The SWAL-QoL consists of 44 items distributed in 11 domains meal duration desire to eat food selection communication burden fear social role mental health fatigue and sleep It is easy to apply and provides information on self-perception of quality of life It assesses the impact of dysphagia on the patient symptoms how dysphagia affects food choices the social impact of dysphagia among others Each item is rated from 1 to 5 1 represents the worst state and 5 represents the most favorable state and is grouped into 10 scales that are evaluated independently with 0 being the least favorable and 100 the most favorable Lower scores are associated with poorer quality of life
Death yesno If it occurs from inclusion in the study until its completion If it occurs the date of death will be recorded Collected from the medical record
Nutritional adaptation Prescribed diet type of hospital diet or enteral nutrition and route of administration oral NG tube or percutaneous endoscopic gastrostomy PEG
An ad hoc data collection form has been developed where all study variables will be recorded on a sheet for each participant Data will be safeguarded to preserve participantsamp39 privacy and confidentiality and a database will be created for subsequent analysis
Data Collection
After receiving approval from the Research Ethics Committee for Medicines CEIm of the Albacete Health Area as well as authorization from the department head and ICU supervisor at CHUA and once the suitability of the facilities has been verified data collection will begin for those patients who meet the inclusion criteria and sign the informed consent after having received verbal information All participants will undergo dysphagia assessment using the mV-VST and the recording of variables in the specially designed data collection notebook will commence
The mV-VST is based on testing three textures nectar pudding and liquid prepared with mineral water and a thickener In this study the thickener currently available in the unit will be used and the staff will be properly trained in its use The test begins with the nectar texture gradually increasing the volumes to 5 10 and 15 ml which are deposited consecutively into the mouth using a wide-cone 50 ml syringe These textures will be colored with blue food coloring to better visualize possible pulmonary aspirations distinguishing them from normal secretions which is especially important in tracheotomized patients
For each texture the following safety criteria must be met 1 presence of a cough 2 desaturation greater than 3 3 changes in voice tone not applicable for tracheotomized patients and 4 presence of esophageal residue asking the patient if they feel they havenamp39t swallowed everything If there is no alteration in these parameters with the nectar texture the same process will be followed with the pudding and liquid textures in that order
Liquid is the last viscosity tested because ICU patients have great difficulty swallowing liquids After six intakes at the end of the mV-VST fatigue may worsen dysphagia due to ICU-AW ICU-acquired weakness making the risk of aspiration when ingesting liquids more evident Unlike the original V-VST which considers the presence of pharyngeal residue as a measure of efficacy we evaluate it as a safety parameter as ICU patients with dysphagia are more likely to experience pulmonary aspiration of pharyngeal residue due to reduced strength to clear it back to the mouth Dysphagia and aspiration risk will only be ruled out for patients who show safe swallowing for all tested volumes and viscosities in the mV-VST If any safety parameter is altered the evaluation will be interrupted diagnosing ICU-ASD and aspiration risk A test will be considered POSITIVE and ICU-ASD will be diagnosed when a YES appears in the corresponding box on our data collection sheet meaning that the patient has not tolerated that texture because a safety parameter has been affected eg presence of cough desaturation ampgt3 change in voice tone or appearance of pharyngeal residue
To perform the mV-VST post-extubated patients must have been intubated for 48 hours and the test will be conducted 24 hours after extubation For tracheotomized patients we will wait four days after stoma creation to conduct the test and these patients must be disconnected from invasive mechanical ventilation for at least 6 hours a day
Patients must be awake conscious and cooperative with a RASS 0 and a negative CAM-ICU During the procedure the patient will remain seated in bed at least 45 or in a chair and will be monitored throughout For tracheostomized patients the test will be performed with the cuff deflated and for those who can tolerate it with a speaking valve
Patient identification will be done using a consecutive inclusion number in the study respecting data confidentiality
The weight recorded at admission will be the one reported by the patient or family considering the impossibility of weighing patients due to clinical instability upon ICU admission After extubation weight will be recorded either from the bed scale or chair scale depending on the patientamp39s condition Height will be recorded when it is possible to measure the patient using a stadiometer same brand and model available throughout CHUA
The patient will follow the usual practice in both the ICU hospitalization ward and post-ICU clinic The occurrence of outcome variables will be monitored including respiratory complications and readmissions as well as the nutritional status being evaluated
Based on the mV-VST result the patientamp39s diet will be adapted or if oral feeding is impossible it will be decided whether to administer enteral nutrition via NGT nasogastric tube or PEG percutaneous endoscopic gastrostomy which will be recorded in the clinical history and the investigators will document
During hospitalization and after ICU discharge the patient will be followed up recording the results of dysphagia evaluations performed if continued to be necessary noting anthropometric and biochemical parameters and monitoring the occurrence of outcome variables
After hospital discharge patients will be monitored through computerized clinical history looking for new admissions due to complications as well as visits to their health center or emergency department
Patients are usually scheduled for post-ICU follow-up visits at 30 and 90 days after hospital discharge During these visits the mV-VST will be reevaluated if necessary and at the 90-day visit the perceived quality of life will be assessed using the Swallowing Quality of Life Questionnaire for the adult population SWAL-QoL
Objectives
Primary Objective To analyze the occurrence of respiratory and nutritional complications associated with ICU-Acquired Swallowing Disorder ICU-ASD in patients intubated for more than 48 hours or tracheostomized in the multidisciplinary ICU at CHUA and to explore potential factors related to their occurrence
Secondary Objectives
To determine the incidence of ICU-ASD in the multidisciplinary ICU at CHUA To determine the frequency of respiratory complications in post-extubated and tracheostomized patients in the multidisciplinary ICU at CHUA
To assess the nutritional status of post-extubated and tracheostomized patients in the multidisciplinary ICU at CHUA
To evaluate the quality of life with dysphagia in patients who developed ICU-ASD after hospital discharge
To determine the mortality rate of post-extubated and tracheostomized patients in the ICU at CHUA
SAMPLE SIZE Since there is no existing data on complications caused by dysphagia in our unit we have considered the study by McIntyre et al 2022 which shows an incidence of pneumonia of 21 in patients with ICU-ASD and 9 in extubated patients without dysphagia OR251 95 CI 127-495 Based on these premises the sample size was calculated using the Epiinfo program estimating a 95 confidence interval CI 80 power and a 11 group ratio We obtain a sample of 360 participants adding 15 for potential losses which means an additional 54 patients The final sample size to be achieved is 414 participants Participants will be selected through consecutive sampling meeting inclusion criteria and always with signed consent after verbal information and delivery of the information sheet According to statistical data from the CHUA ICU from previous years achieving this sample will likely take two years
RECRUITMENT PERIOD September 2024-September 2026 2 years STUDY COMPLETION Completion of the study until the end of follow-up death or withdrawal of informed consent
VARIABLES AND MEASUREMENT INSTRUMENTS
Age difference between date of birth and admission date Collected from the medical record
Sex malefemale As recorded in the medical record Comorbidities personal history of disease Collected from the medical record Categorized admission diagnosis cardiovascular respiratory gastrointestinal neurological trauma metabolic hematological urological intoxications and others These may be later analyzed as two groups NEUROCRITICALNON-NEUROCRITICAL
Presence of NG tube and number of days Number and type Levin Flekka nasojejunal Collected from the patientamp39s daily ICU chart
Endotracheal tube used number and type subglotticnon-subglottic Collected from the vital signs chart
Tracheostomy technique used for insertion PERCUTANEOUSSURGICAL cannula number and type with cuffwithout cuff Collected from the patientamp39s vital signs chart
Days of pre-ICU admission ICU admission date - hospital admission date Collected from the medical record
Days of ICU admission date of transfer to the ward or death - ICU admission date Collected from the medical record
Days of post-ICU admission from transfer to the ward until discharge Collected from the medical record
Total hospital stay day of discharge - day of admission Collected from the medical record
Days with invasive mechanical ventilation IMV Collected from the ICU vital signs chart
Days with endotracheal tube ETT Collected from the ICU vital signs chart Days with tracheostomy Collected from the ICU vital signs chart Discharge destination homehealthcare facility Collected from the medical record at the time of nursing discharge
Patient severity in ICU using the Acute Physiology And Chronic Health Evaluation APACHE II Collected from the patientamp39s medical record
Sequential Organ Failure Assessment SOFA Collected from the patientamp39s medical record
Nutritional parameters
Body Mass Index BMI We will collect weight and height referring to the baseline state Weight measurement when oral feeding begins the patient will be weighed on a chair or bed scale Upon transfer to the ward chair scale At one month and three months in the post-ICU clinic Height measurement the first time it is possible to measure with a stadiometer
Biochemical parameters prealbumin cholesterol and C-reactive protein CRP Collected from the medical record The week the swallowing test is performed the day of transfer to the ward at discharge and at 30 days in the clinic
Existence of ICU-ASD determined using the mV-VST13 To perform the test the patient must have an adequate level of consciousness RASS 0 and CAM-ICU negative The test will always be performed before starting oral intake If positive indicating ICU-ASD it will be repeated weekly in the ward each week while positive If it remains positive it will be followed up in the endocrinology clinic so data from their assessments will be collected
Respiratory complications
Respiratory infections We collect diagnoses of TRACHEOBRONCHITIS and PNEUMONIA described in the medical record The diagnosis can occur throughout the follow-up including visits to the health center and emergency services Record the date from the medical record
Bronchoaspiration Described in the medical record as confirmed or suspected Bronchoaspiration yesno and the date it occurs
Reintubation yesno Number of times Collected from the ICU vital signs chart Hospital readmissions due to swallowing disorder complications As described in the admission note Collected from the computerized medical record
Emergency visits due to swallowing disorder complications Collected from the computerized medical record
Quality of life using the Swallowing Quality of Life Questionnaire for adults SWAL-QoL The SWAL-QoL consists of 44 items distributed in 11 domains meal duration desire to eat food selection communication burden fear social role mental health fatigue and sleep It is easy to apply and provides information on self-perception of quality of life It assesses the impact of dysphagia on the patient symptoms how dysphagia affects food choices the social impact of dysphagia among others Each item is rated from 1 to 5 1 represents the worst state and 5 represents the most favorable state and is grouped into 10 scales that are evaluated independently with 0 being the least favorable and 100 the most favorable Lower scores are associated with poorer quality of life
Death yesno If it occurs from inclusion in the study until its completion If it occurs the date of death will be recorded Collected from the medical record
Nutritional adaptation Prescribed diet type of hospital diet or enteral nutrition and route of administration oral NG tube or percutaneous endoscopic gastrostomy PEG
An ad hoc data collection form has been developed where all study variables will be recorded on a sheet for each participant Data will be safeguarded to preserve participantsamp39 privacy and confidentiality and a database will be created for subsequent analysis
Data Collection
After receiving approval from the Research Ethics Committee for Medicines CEIm of the Albacete Health Area as well as authorization from the department head and ICU supervisor at CHUA and once the suitability of the facilities has been verified data collection will begin for those patients who meet the inclusion criteria and sign the informed consent after having received verbal information All participants will undergo dysphagia assessment using the mV-VST and the recording of variables in the specially designed data collection notebook will commence
The mV-VST is based on testing three textures nectar pudding and liquid prepared with mineral water and a thickener In this study the thickener currently available in the unit will be used and the staff will be properly trained in its use The test begins with the nectar texture gradually increasing the volumes to 5 10 and 15 ml which are deposited consecutively into the mouth using a wide-cone 50 ml syringe These textures will be colored with blue food coloring to better visualize possible pulmonary aspirations distinguishing them from normal secretions which is especially important in tracheotomized patients
For each texture the following safety criteria must be met 1 presence of a cough 2 desaturation greater than 3 3 changes in voice tone not applicable for tracheotomized patients and 4 presence of esophageal residue asking the patient if they feel they havenamp39t swallowed everything If there is no alteration in these parameters with the nectar texture the same process will be followed with the pudding and liquid textures in that order
Liquid is the last viscosity tested because ICU patients have great difficulty swallowing liquids After six intakes at the end of the mV-VST fatigue may worsen dysphagia due to ICU-AW ICU-acquired weakness making the risk of aspiration when ingesting liquids more evident Unlike the original V-VST which considers the presence of pharyngeal residue as a measure of efficacy we evaluate it as a safety parameter as ICU patients with dysphagia are more likely to experience pulmonary aspiration of pharyngeal residue due to reduced strength to clear it back to the mouth Dysphagia and aspiration risk will only be ruled out for patients who show safe swallowing for all tested volumes and viscosities in the mV-VST If any safety parameter is altered the evaluation will be interrupted diagnosing ICU-ASD and aspiration risk A test will be considered POSITIVE and ICU-ASD will be diagnosed when a YES appears in the corresponding box on our data collection sheet meaning that the patient has not tolerated that texture because a safety parameter has been affected eg presence of cough desaturation ampgt3 change in voice tone or appearance of pharyngeal residue
To perform the mV-VST post-extubated patients must have been intubated for 48 hours and the test will be conducted 24 hours after extubation For tracheotomized patients we will wait four days after stoma creation to conduct the test and these patients must be disconnected from invasive mechanical ventilation for at least 6 hours a day
Patients must be awake conscious and cooperative with a RASS 0 and a negative CAM-ICU During the procedure the patient will remain seated in bed at least 45 or in a chair and will be monitored throughout For tracheostomized patients the test will be performed with the cuff deflated and for those who can tolerate it with a speaking valve
Patient identification will be done using a consecutive inclusion number in the study respecting data confidentiality
The weight recorded at admission will be the one reported by the patient or family considering the impossibility of weighing patients due to clinical instability upon ICU admission After extubation weight will be recorded either from the bed scale or chair scale depending on the patientamp39s condition Height will be recorded when it is possible to measure the patient using a stadiometer same brand and model available throughout CHUA
The patient will follow the usual practice in both the ICU hospitalization ward and post-ICU clinic The occurrence of outcome variables will be monitored including respiratory complications and readmissions as well as the nutritional status being evaluated
Based on the mV-VST result the patientamp39s diet will be adapted or if oral feeding is impossible it will be decided whether to administer enteral nutrition via NGT nasogastric tube or PEG percutaneous endoscopic gastrostomy which will be recorded in the clinical history and the investigators will document
During hospitalization and after ICU discharge the patient will be followed up recording the results of dysphagia evaluations performed if continued to be necessary noting anthropometric and biochemical parameters and monitoring the occurrence of outcome variables
After hospital discharge patients will be monitored through computerized clinical history looking for new admissions due to complications as well as visits to their health center or emergency department
Patients are usually scheduled for post-ICU follow-up visits at 30 and 90 days after hospital discharge During these visits the mV-VST will be reevaluated if necessary and at the 90-day visit the perceived quality of life will be assessed using the Swallowing Quality of Life Questionnaire for the adult population SWAL-QoL
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