| 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
|
|
|
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
|
|
|
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). |