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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G969||Disorder of central nervous system, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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. 
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