FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/03/064172 [Registered on: 15/03/2024] Trial Registered Prospectively
Last Modified On: 02/06/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study
Modification(s)  
International observational study on airway management in operating room and outside operating room anaesthesia. STARGATE Study. 
Scientific Title of Study   International observational study on airway management in operating room and non-operating room anaesthesia. STARGATE Study. 
Trial Acronym  STARGATE Study 
Secondary IDs if Any  
Secondary ID  Identifier 
NCT05759299 (Protocol version 1.2 - June 2023)  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Neha Singh 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, Bhubaneswar 
Address  Room No. 426, Academic Block, Department of Anesthesiology and Critical care, All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar, Odisha, India

Khordha
ORISSA
751019
India 
Phone  9438884045  
Fax    
Email  drneha.com@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Neha Singh 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, Bhubaneswar 
Address  Room No. 426, Academic Block, Department of Anesthesiology and Critical care, All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar, Odisha, India

Khordha
ORISSA
751019
India 
Phone  9438884045  
Fax    
Email  drneha.com@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Neha Singh 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, Bhubaneswar 
Address  Room No. 426, Academic Block, Department of Anesthesiology and Critical care, All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar, Odisha, India

Khordha
ORISSA
751019
India 
Phone  9438884045  
Fax    
Email  drneha.com@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Sijua Patrapada Bhubaneswar Pin Odisha India 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Sijua Patrapada Bhubaneswar, Odisha India 
Address  All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar, Pin-751019 Odisha, India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Neha Singh  All India Institute of Medical Sciences, Bhubaneswar  S2+2 and S2+4 Block, Pre-operative area OT complex, Department of Anesthesiology and Critical Care, AIIMS, Bhubaneswar, Khordha, ORISSA
Khordha
ORISSA 
9438884045

drneha.com@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, All India Institute of Medical Sciences, Bhubaneswar   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N289||Disorder of kidney and ureter, unspecified, (2) ICD-10 Condition: C179||Malignant neoplasm of small intestine, unspecified, (3) ICD-10 Condition: H749||Unspecified disorder of middle earand mastoid,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  patients undergoing intubation for general anaesthesia in operating room (OR) or non-operating room anaesthesia (NORA). 
 
ExclusionCriteria 
Details  Airway management during cardiopulmonary resuscitation; critically ill patients undergoing intubation due to their underlying clinical condition. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
At least one of the following major peri-intubation adverse events like severe hypoxia, cardiovascular collapse, cardiac arrest.  within 30 minutes from intubation or up to surgical incision 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the current practice of airway management during anaesthesia worldwide.  with in 30 minutes from intubation or up to surgical incision. 
 
Target Sample Size   Total Sample Size="10500"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/03/2024 
Date of Study Completion (India) 26/12/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  

According to WHO, more than 230 million major surgical procedures are carried out under general anaesthesia each year worldwide (1). Despite important technological advances, airway management remains a major challenge in anaesthesiology.

The National Audit Project 4, published in 2011, for the first time addressed the need to systematically collect information on major airway-related complications in both the anaesthesia and critical care settings. While in the critical care setting the report provided important insights for improvement, incidence of major adverse events such as death, brain damage and need for emergency surgical airway appeared underestimated in anaesthesia (2) so that for every case captured by NAP4 there may be another 720 potential airway events if we consider hypoxemia and cardiovascular collapse (3).

Traditionally, airway management in anaesthesia has been described as anatomically difficult as opposed to airway management in critical care defined as physiologically difficult.

Critically ill patients are prone to a higher airway-related risk due to their underlying hypoxemia, shock, acidosis which expose them to the high incidence of adverse events, especially cardiovascular collapse, recently reported in the INTUBE study cohort (4). Data from large prospective studies on current incidence of major peri-intubation adverse events are lacking in the anaesthesia setting, especially on outcomes such as peri-intubation cardiovascular collapse, severe hypoxemia, and cardiac arrest (5)(6).

These events are more common in case of difficulties with airway management so that first pass intubation failure significantly increases the risks (7)(8). Moreover, it has been documented that even transient hypotension during general anaesthesia, may have long-term consequences and may be associated with a worse outcome in patients undergoing non-cardiac surgery (9).

 
Close