Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06442930
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-03-28
Brief Title:
EXtubation Related Complications - the EXTUBE Study EXTUBE
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
EXtubation Related Complications - an International Observational Study To Understand the Impact and BEst Practices in the Operating Room and Intensive Care Unit - the EXTUBE Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EXTUBE
Brief Summary:
EXTUBE is an international multicentre prospective cohort study evaluating the incidence risk factors and outcomes of extubation-related complications and describing clinical practices related to extubation after general anesthesia or after critical illness in the operating room OR out of OR anesthesia location or intensive care unit ICU
Detailed Description:
Globally over 200 million people each year require extubation While routinely performed extubation is a skilled and potentially high-risk procedure that should be performed only when physiologic pharmacologic and contextual conditions are optimalComplications at this stage of patient care can result in decreased oxygen delivery to the brain and body sometimes leading to serious adverse events such as cardiac arrest brain damage or death Indeed one quarter of airway complications that result in death or brain death occur at the time of extubation
Despite the frequency of extubation and the potential for life-threatening complications there is a lack of systematic data on the rate and circumstances under which these severe complications occur The limited data indicate 10-30 of extubations may lead to severe complications depending on the population and outcome definition However the certainty of these estimates is severely limited because they are based on studies that are small mostly single-center based on clinician recall only capture a small portion of extubation complications eg malpractice claims or do not reflect current clinical practice In addition most lack a denominator and exclude successful extubations making estimates of actual complication rates and risk factors impossible
There has been no large study of extubation techniques or adherence to guidelines so procedural factors associated with complications must be elucidated While adherence to clinical practice guidelines has not been formally evaluated surveys show non-adherence to some best practices and considerable variation in practice and data from audits and medicolegal claims show that lack of adherence to best practices is frequently at the root cause of severe adverse extubation outcomes with half of the complications deemed preventable Therefore data on the frequency and nature of extubation complications patient and procedural risk factors for complications and guideline adherence rates are needed before these preventable events can be addressed
EXTUBE EXtubation related complications - an international observational study To Understand the impact and BEst practices in the operating room and intensive care unit is an international multicenter prospective cohort study
The primary objective of this study is to determine the incidence of severe extubation-related complications within 60 minutes after extubation in adults who have undergone mechanical ventilation for general anesthesia or critical illness The secondary objectives are to determine 1 the incidence of mild extubation complications 2 patient- and procedure-related risk factors for extubation complications 3 the association between extubation complications and outcomes until hospital discharge and 4 the rate of adherence to extubation clinical practice guidelines
Despite the frequency of extubation and the potential for life-threatening complications there is a lack of systematic data on the rate and circumstances under which these severe complications occur The limited data indicate 10-30 of extubations may lead to severe complications depending on the population and outcome definition However the certainty of these estimates is severely limited because they are based on studies that are small mostly single-center based on clinician recall only capture a small portion of extubation complications eg malpractice claims or do not reflect current clinical practice In addition most lack a denominator and exclude successful extubations making estimates of actual complication rates and risk factors impossible
There has been no large study of extubation techniques or adherence to guidelines so procedural factors associated with complications must be elucidated While adherence to clinical practice guidelines has not been formally evaluated surveys show non-adherence to some best practices and considerable variation in practice and data from audits and medicolegal claims show that lack of adherence to best practices is frequently at the root cause of severe adverse extubation outcomes with half of the complications deemed preventable Therefore data on the frequency and nature of extubation complications patient and procedural risk factors for complications and guideline adherence rates are needed before these preventable events can be addressed
EXTUBE EXtubation related complications - an international observational study To Understand the impact and BEst practices in the operating room and intensive care unit is an international multicenter prospective cohort study
The primary objective of this study is to determine the incidence of severe extubation-related complications within 60 minutes after extubation in adults who have undergone mechanical ventilation for general anesthesia or critical illness The secondary objectives are to determine 1 the incidence of mild extubation complications 2 patient- and procedure-related risk factors for extubation complications 3 the association between extubation complications and outcomes until hospital discharge and 4 the rate of adherence to extubation clinical practice guidelines
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None