Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06538740
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-02
Brief Title:
Impact of High Versus Lower Oxygen Fraction Prior to Extubation on Postoperative Pulmonary Atelectasis Measured with EIT
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Trial Investigating the Impact of High Versus Lower Oxygen Fraction During Extubation on Postoperative Pulmonary Atelectasis Measured with Electrical Impedance Tomography
Status:
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:
RESPIRA-EIT
Brief Summary:
Patients undergoing general anesthesia require mechanical ventilation artificial delivery of air and oxygen to their lungs It is well known that during mechanical ventilation so called atelectasis formation occurs This is a condition characterized by partial or complete collapse of lung tissue that can result in a reduction in oxygen uptake through the lung A known risk factor for atelectasis formation during mechanical ventilation is the utilization of high oxygen concentration as the oxygen molecules are absorbed in the lung which then can lead to collapse of the tissue Despite the proven association standard operating procedure at the end of anesthesia still requires utilization of 100 oxygen Its justification is the goal to ensure sufficient oxygenation throughout the extubation phase However clinical observation doesnt show a lack of oxygenation in this phase but the patient is still exposed to the risk of atelectasis formation
This study aims to investigate the hypothesis of whether the utilization of reduced oxygen concentration before extubation 70 compared to 100 reduces atelectasis formation Patients who participate in this study are randomly ie by chance assigned to either the control group receiving standard care 100 oxygen at the end of anesthesia or the intervention group receiving 70 oxygen Of note this is still 3 times as much as when breathing standard room air which has 21 oxygen During the intervention parameters such as the oxygen content in the blood oxygen saturation SpO2 heart rate and blood pressure are recorded and atelectasis formation is measured using a technique called electrical impedance tomography EIT EIT measurements are performed at designated timepoints during the procedure Anesthesia care providers are asked to document procedural patient and ventilator data in a questionnaire Secondary outcomes are the homogeneity and distribution of air measured with EIT as well as some clinical outcomes including post-extubation desaturation 90 SpO2 incidence of re-intubation or non-invasive ventilation and the Post-anesthesia Care Unit PACU length of stay
This study aims to investigate the hypothesis of whether the utilization of reduced oxygen concentration before extubation 70 compared to 100 reduces atelectasis formation Patients who participate in this study are randomly ie by chance assigned to either the control group receiving standard care 100 oxygen at the end of anesthesia or the intervention group receiving 70 oxygen Of note this is still 3 times as much as when breathing standard room air which has 21 oxygen During the intervention parameters such as the oxygen content in the blood oxygen saturation SpO2 heart rate and blood pressure are recorded and atelectasis formation is measured using a technique called electrical impedance tomography EIT EIT measurements are performed at designated timepoints during the procedure Anesthesia care providers are asked to document procedural patient and ventilator data in a questionnaire Secondary outcomes are the homogeneity and distribution of air measured with EIT as well as some clinical outcomes including post-extubation desaturation 90 SpO2 incidence of re-intubation or non-invasive ventilation and the Post-anesthesia Care Unit PACU length of stay
Detailed Description:
This study is a single blinded randomized controlled trial with two study arms intervention and control and aims to assess whether the use of 100 oxygen before extubation favors postoperative atelectasis formation compared to the use of 70 oxygen concentration whilst still ensuring patient safety
The randomization scheme is developed by a non-blinded statistician using the Statistical Analysis Software SAS and uploaded to the Research Electronic Data Capture REDCap randomization module enabling delegated team members to generate sequential allocations for enrolled subjects
Screening of potential study subjects is performed by the PI The patient is asked to participate in the study by the PI or co-investigator and the study design and procedures are explained to the patient while they are still in the holding area on the day of the procedure
The patients in both groups intervention and control are equipped with the EIT belt as well as an additional SpO2 recording device before induction and intubation After onset of mechanical ventilation as to institutional standards an inspiratory oxygen concentration of 50 is aimed Actual oxygen concentration as well as any administration of drugs remain at the discretion of the anesthesia care provider At the end of the procedure before the initiation of volatile anesthetic washout fresh gas flow is increased to 15 liters per minute or the highest fresh gas flow allowed at the respective anesthesia machine if 15 liters per minute cannot be achieved and a fraction of inspired oxygen FiO2 of either 70 intervention group or 100 control group is applied
EIT measurements take place at 6 designated time points before during and after the procedure These time points are Pre-induction after intubation just before washout pre-extubation one minute after extubation and 60 minutes after extubation in the PACU
The primary outcome for the study is the Center of Ventilation CoV measured through electrical impedance tomography EIT compared at one minute after extubation between the two groups
Secondary outcomes include the homogeneity index and the distribution of lung aeration measured by EIT In addition we measure the peripheral oxygen concentration during the whole interventional period and during the PACU stay to evaluate any occurrence of desaturation SpO2 90 within the first 60 minutes after extubation in the PACU The incidence of re-intubation or the need for non-invasive ventilation in the next 7 days and an unplanned admission to either ICU Intermediate Care Unit IMC or the normal ward as well as the length of stay in the PACU are other clinical secondary outcomes compared between the two groups
The randomization scheme is developed by a non-blinded statistician using the Statistical Analysis Software SAS and uploaded to the Research Electronic Data Capture REDCap randomization module enabling delegated team members to generate sequential allocations for enrolled subjects
Screening of potential study subjects is performed by the PI The patient is asked to participate in the study by the PI or co-investigator and the study design and procedures are explained to the patient while they are still in the holding area on the day of the procedure
The patients in both groups intervention and control are equipped with the EIT belt as well as an additional SpO2 recording device before induction and intubation After onset of mechanical ventilation as to institutional standards an inspiratory oxygen concentration of 50 is aimed Actual oxygen concentration as well as any administration of drugs remain at the discretion of the anesthesia care provider At the end of the procedure before the initiation of volatile anesthetic washout fresh gas flow is increased to 15 liters per minute or the highest fresh gas flow allowed at the respective anesthesia machine if 15 liters per minute cannot be achieved and a fraction of inspired oxygen FiO2 of either 70 intervention group or 100 control group is applied
EIT measurements take place at 6 designated time points before during and after the procedure These time points are Pre-induction after intubation just before washout pre-extubation one minute after extubation and 60 minutes after extubation in the PACU
The primary outcome for the study is the Center of Ventilation CoV measured through electrical impedance tomography EIT compared at one minute after extubation between the two groups
Secondary outcomes include the homogeneity index and the distribution of lung aeration measured by EIT In addition we measure the peripheral oxygen concentration during the whole interventional period and during the PACU stay to evaluate any occurrence of desaturation SpO2 90 within the first 60 minutes after extubation in the PACU The incidence of re-intubation or the need for non-invasive ventilation in the next 7 days and an unplanned admission to either ICU Intermediate Care Unit IMC or the normal ward as well as the length of stay in the PACU are other clinical secondary outcomes compared between the two groups
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