| CTRI Number |
CTRI/2025/06/089091 [Registered on: 18/06/2025] Trial Registered Prospectively |
| Last Modified On: |
17/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Observational |
| Study Design |
Other |
|
Public Title of Study
|
A study to understand the problems and best methods related to removal of breathing tube inserted in windpipe of patients in operation theatres and intensive care unit |
|
Scientific Title of Study
|
EXtubation related complications- an international observational study To Understand the impact and BEst practices in the operating room and intensive care unit (EXTUBE Study) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 4776_Version 3.0 dated 28.11.2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sheila Nainan Myatra |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Anesthesia, Critical care and Pain, Major OT complex, Second floor, Main Building, Tata Memorial Hospital Dr E Borges Road Parel Mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
9820156070 |
| Fax |
|
| Email |
sheila150@hotmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sheila Nainan Myatra |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Anesthesia, Critical care and Pain, Major OT complex, Second floor, Main Building, Tata Memorial Hospital Dr E Borges Road Parel Mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
9820156070 |
| Fax |
|
| Email |
sheila150@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sheila Nainan Myatra |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Anesthesia, Critical care and Pain, Major OT complex, Second floor, Main Building, Tata Memorial Hospital Dr E Borges Road Parel Mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
9820156070 |
| Fax |
|
| Email |
sheila150@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital Dr E Borges Road Parel Mumbai 400012 |
|
|
Primary Sponsor
|
| Name |
Toronto General hospital |
| Address |
Toronto General Hospital
200 Elizabeth Street, 3EN
Toronto, ON, Canada
M5G 2C4 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India Australia Canada Germany United Kingdom United States of America |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sheila Nainan Myatra |
Tata Memorial Hospital |
Department of Anesthesia Critical care and Pain, Second floor, Major OT complex, Main Building, Tata Memorial Centre Dr E Borges Road Parel Mumbai Mumbai MAHARASHTRA |
9820156070
sheila150@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Memorial Hospital Institutional Ethics Committee II |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients (greater than or equals to 18 years old) undergoing extubation of an endotracheal tube (including index extubation and re-extubations) after general anesthesia in the OR, out of OR anesthesia location or ICU during the specified enrollment window will be included. |
|
| ExclusionCriteria |
| Details |
Patients will be excluded if the extubation is:
(i) performed in the context of withdrawal of life support measures or
(ii) performed for tracheostomy decannulation.
For each patient who is not included, reasons for exclusion will be reported. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary outcome will be the occurrence of at least one of the following (composite outcome) occurring within 60 minutes after the end of extubation
1. Severe hypoxemia (oxygen saturation as measured by pulse oximetry falls below SpO2 less than 80% for more than 5 minutes)
2. Cardiac arrest
3. Need for airway management (reintubation, insertion of a supraglottic airway, bag-mask ventilation). |
within 60 minutes of extubation
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary outcomes will include the new occurrence of the following complications:
1. Difficult and complications related to airway management (eg esophageal intubation) if reintubation is required
2. Planned and unplanned non-invasive respiratory support or high flow nasal cannula
3. Emergency front of neck airway
4. Cardiac arrhythmia requiring chemical or electrical treatment
5.Severe hypotension
6. Severe hypertension
7. Aspiration of gastric contents
8. Pneumothorax/pneumo-mediastinum,
9. Dental injury
10. Airways injury
|
within 60 minutes of extubation |
|
|
Target Sample Size
|
Total Sample Size="3000" Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/07/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Globally, it is estimated that over 200 million people each year require mechanical ventilation using an endotracheal tube, as part of general anesthesia for surgery or as a life saving intervention in critical illnesses (for example, in severe respiratory failure due to pneumonia). Once a patient has recovered, the endotracheal tube is removed, a process called ‘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 optimal. The decision of when and how to extubate a patient can be challenging because optimizing certain conditions can antagonize others. For example, extubation while the patient is fully anesthetized before upper airway reflexes return prevents laryngospasm but increases the risk of aspiration. Complications 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, in audits and safety reports, one quarter of airway complications that result in death or brain death occur at the time of extubation. Each of the last 5 semi annual safety bulletins of critical care incidents in England report serious adverse complications of extubation resulting in patients’ death. In all these cases, the experts’ opinion reflected that these complications could have been prevented with proper planning and timing, adequate techniques and expertise at the bedside. Despite the frequency of extubation and the potential for life threatening complications of extubation failure, we currently lack systematic data on the rate and circumstances under which these severe complications occur. The limited data on complication rates indicate 30% of extubations may lead to severe complications, de pending on the population and outcome definition. However, the certainty of these estimates is severely limited because they are based on studies that are small, 11 mostly single centre, based on clinician recall, only capture a small portion of extubation complications, or do not reflect current clinical practice. Beyond these data, extubation complications and practices have not been thoroughly studied Yet extubation management decisions and outcomes depend on a complex interplay of patien t and situational characteristics so a large, systematic study would be required to make conclusions about the best extubation technique in various patient populations and settings. Historically, extubation has received significantly less research attention than intubation (i.e the process of inserting the endotracheal tube at the start of mechanical ventilation), even though complications at extubation may occur as frequently as complications at intubation, but may have increased risk of severe patient harm. Promisingly, a recent focus on intubation complications, risk factors, and best practices has decreased intubation related complications an evidence based bundle of intubation strategies decreased airway complications by 26% suggesting that a similar program of research focusing on extubation could have a comparable impact on patient safety and outcomes. As a result, there have been calls for research to identify risks of extubation complications and effective extubation techniques. In particular, high quality baseline data on complication rates are needed to evaluate future interventions and clinical practice guidelines. High quality data on patient risk factors for complications are needed because current guidelines specify that extubation algorithms should be selected based on patient risk level, but risk factors to date are based mainly on expert opinion. The algorithms themselves are based on case studies and expert opinion as there has been no large scale study of the effectiveness of individual extubation techniques or guidelines, so procedural factors associated with complications need to be elucidated. While adherence to clinical practice guidelines has not been formally evaluated, surveys of anesthesiology and critical care professionals show non adherence to some best practices and considerable variation in practice Lack of adherence to best practices is frequently at the root cause of serious adverse outcomes of extubation, according to data from audits and medicolegal claims, suggesting that half of the complications are preventable For example, half of adverse events associated with extubation in a large audit had evidence of poor planning 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. We propose the EXTUBE study, the first systematic, large, international prospective cohort study evaluating the incidence, risk factors, and outcomes of extubation related complications and describing clinical practices related to extubation. We will use an innovative, point prevalence design that we recently adopted to successfully conduct the INTUBE study the largest ever study on endotracheal intubation in critically ill patients. These data will provide a precise understand ing of current extubation practices and associated complications, and will be fundamental in informing targeted interventions to improve patient safety. |