CTRI Number |
CTRI/2019/01/017206 [Registered on: 23/01/2019] Trial Registered Prospectively |
Last Modified On: |
22/01/2019 |
Post Graduate Thesis |
No |
Type of Trial |
Observational |
Type of Study
|
Cohort Study |
Study Design |
Single Arm Study |
Public Title of Study
|
INternational observational study To Understand current practices for managing the respiratory support in critically ill patients |
Scientific Title of Study
|
INternational observational study To Understand the impact and BEst practices of airway management in critically ill patients |
Trial Acronym |
INTUBE study |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Gopalakrishna K N |
Designation |
Associate professor |
Affiliation |
National Institute of Mental Health and Neurosciences, Bangalore |
Address |
Department of Neuroanaesthesia and Neurocritical,
NIMHANS, Hosur road, Bangalore
Door No: 868, 9th main, BTM layout 2nd stage, Bangalore 560076 Bangalore KARNATAKA 560029 India |
Phone |
9916469626 |
Fax |
|
Email |
gops868@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Gopalakrishna K N |
Designation |
Associate professor |
Affiliation |
National Institute of Mental Health and Neurosciences, Bangalore |
Address |
Department of Neuroanaesthesia and Neurocritical,
NIMHANS, Hosur road, Bangalore
Door No: 868, 9th main, BTM layout 2nd stage, Bangalore 560076 Bangalore KARNATAKA 560029 India |
Phone |
9916469626 |
Fax |
|
Email |
gops868@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Gopalakrishna K N |
Designation |
Associate professor |
Affiliation |
National Institute of Mental Health and Neurosciences, Bangalore |
Address |
Department of Neuroanaesthesia and Neurocritical,
NIMHANS, Hosur road, Bangalore
Door No: 868, 9th main, BTM layout 2nd stage, Bangalore 560076 Bangalore KARNATAKA 560029 India |
Phone |
9916469626 |
Fax |
|
Email |
gops868@gmail.com |
|
Source of Monetary or Material Support
|
National Institute of Mental Health and Neurosciences, Bangalore |
|
Primary Sponsor
|
Name |
Non funded project |
Address |
Not applicable (NA) |
Type of Sponsor |
Research institution |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
Australia Austria Bangladesh Brazil Bulgaria Canada Colombia Denmark France Germany Greece India Indonesia Ireland Italy Malaysia Mexico Nepal Netherlands New Zealand Oman Pakistan Poland Portugal Qatar Saudi Arabia Sweden Taiwan Thailand Turkey 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 |
Gopalakrishna K N |
National Institute of Mental Health and Neurosciences |
3rd floor, Faculty block,
Department of Neuroanaesthesia and Neurocritical care Bangalore KARNATAKA |
9916469626
gops868@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
NIMHANS Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: G969||Disorder of central nervous system, unspecified, |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
1) We will include all adult (equal or more than 18 years old) critically ill patients undergoing intubation during the period of observation.
2) We will consider all in-hospital intubations. |
|
ExclusionCriteria |
Details |
1) Intubation performed in the out-of-hospital setting
2) Intubation during cardiac arrest
3) Intubation performed for anaesthesia (during either diagnostic/endoscopic or surgical procedures)
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To evaluate the incidence of intubation related adverse
events in critically ill patients
|
3 different time points |
|
Secondary Outcome
|
Outcome |
TimePoints |
To evaluate current clinical practices on airway management in the in-hospital critical care setting |
3 different time points |
|
Target Sample Size
|
Total Sample Size="3600" Sample Size from India="20"
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)
|
01/02/2019 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
01/10/2018 |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="0" Months="2" Days="0" |
Recruitment Status of Trial (Global)
|
Open to Recruitment |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
None yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Endotracheal intubation (ETI) in critically ill patients is a potentially life-threatening procedure and approximately one-third of ETIs is complicated by severe hypoxia, cardiovascular collapse and cardiac arrest. Critically ill are prone to severe complications as the consequence of the underlying acute respiratory failure or hemodynamic instability, reduced oxygen stores and increased oxygen consumption. Moreover, the rate of difficult airway management may be higher in the intensive care unit (ICU) and in the Emergency Department (ED), prolonging the apnea time and the risk of desaturation. Finally, operator’s skills, procedures, devices and drugs, among others, may influence airway management success and patient’s outcome. Despite the high risk of the procedure, different interventions lack high-quality evidence and we hypothesize that a heterogeneous practice among different centres and geographical areas may be found . This project aims to prospectively collect data on the current impact of ETI-related adverse events and current airway management practice in critically ill patients. This is an observational multi-centre international cohort study from different centres (at least 180 centres) all over the world. Each centre has to collect data of 20 endotracheal intubations over a maximum period of 8 weeks. Objectives of the study a) The primary aim of this study is to evaluate the incidence of intubation-related adverse events in critically ill patients. b) Secondary aim is to evaluate current clinical practices on airway management in the in-hospital critical care setting. |