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CTRI Number  CTRI/2025/08/093257 [Registered on: 19/08/2025] Trial Registered Prospectively
Last Modified On: 18/08/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   incidence of cardiac arrest during intubation in patients undergoing emergency intubation 
Scientific Title of Study   Incidence and Predictors of Post Intubation Cardiac Instability in Patients with Physiologically Difficult Airway in Emergency Department: A Prospective Cohort Study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SAURABH TRIVEDI  
Designation  Assistant professor  
Affiliation  AIIMS BHOPAL 
Address  Department of Trauma and Emergency Medicine AIIMS Bhopal MADHYA PRADESH 462020 India

Bhopal
MADHYA PRADESH
462020
India 
Phone  7042461338  
Fax    
Email  drst23@gmail.com   
 
Details of Contact Person
Scientific Query
 
Name  SAURABH TRIVEDI  
Designation  Assistant professor  
Affiliation  AIIMS BHOPAL 
Address  Department of Trauma and Emergency Medicine AIIMS Bhopal MADHYA PRADESH 462020 India

Bhopal
MADHYA PRADESH
462020
India 
Phone  7042461338  
Fax    
Email  drst23@gmail.com   
 
Details of Contact Person
Public Query
 
Name  SAURABH TRIVEDI  
Designation  Assistant professor  
Affiliation  AIIMS BHOPAL 
Address  Department of Trauma and Emergency Medicine AIIMS Bhopal MADHYA PRADESH 462020 India

Bhopal
MADHYA PRADESH
462020
India 
Phone  7042461338  
Fax    
Email  drst23@gmail.com   
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Bhopal, Saket Nagar, Bhopal, M.P, Bhopal 
 
Primary Sponsor  
Name  AIIMS BHOPAL 
Address  AIIMS Bhopal, Saket Nagar, Bhopal. 462020  
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 Saurabh Trivedi  All India Institute of Medical Sciences Bhopal  Department of Trauma & Emergency Medicine, AIIMS Bhopal, Saket Nagar, Bhopal, M.P (462020)
Bhopal
MADHYA PRADESH 
7042461338

drst23@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee, AIIMS Bhopal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R098||Other specified symptoms and signsinvolving the circulatory and respiratory systems,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients with physiological difficult airway undergoing tracheal intubation in emergency department  
 
ExclusionCriteria 
Details  1. Cardiac arrest prior to intubation
2. Intubation outside ED
3. Patients requiring re-intubation within 24 hours
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Incidence of Peri-intubation Cardiac Instability (PICI) within 30 minutes of intubation   Incidence of Peri-intubation Cardiac Instability (PICI) within 30 minutes of intubation  
 
Secondary Outcome  
Outcome  TimePoints 
1. 24-hour, 7-day, and 28-day mortality;
2. ICU and hospital length of stay 
24 hours, 7,28 days after intubation 
 
Target Sample Size   Total Sample Size="550"
Sample Size from India="550" 
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)   15/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
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  

This prospective observational cohort study aims to investigate the incidence and determinants of post-intubation cardiac instability (PICI) among emergency department (ED) patients with physiologically difficult airways (PDA), defined by profound physiological disturbances including severe hypoxemia, hypotension, metabolic acidosis, or shock states. Emergency intubation in such patients, is associated with a heightened risk of peri-intubation cardiovascular collapse and adverse outcomes. Despite this, current airway guidelines focus largely on anatomical difficulty, neglecting the profound physiological derangements that more strongly predict morbidity and mortality.

Existing literature indicates that post-intubation hypotension and cardiac arrest are not uncommon in critically ill patients, with an estimated incidence of cardiovascular instability ranging from 30% to 45%. Russotto et al.’s INTUBE study, involving nearly 3,000 ICU patients, reported a 43.4% incidence of peri-intubation cardiovascular collapse. Similar findings were observed in ED settings, where the presence of shock, hypoxemia, or acidosis was strongly linked to poor outcomes. Emerging tools such as the Difficult Airway Physiological Score (DAPS) further underscore the prognostic importance of physiological parameters over anatomical markers.

The primary objective of this study is to quantify the incidence of PICI in ED patients meeting PDA criteria. Secondary objectives include identifying independent physiologic predictors of PICI, comparing the effects of different induction agents (e.g., ketamine vs etomidate), evaluating the influence of first-pass success and pre-intubation vasopressor use, and developing a preliminary risk stratification tool. Additionally, the study will assess the impact of post-intubation hemodynamic management on short-term outcomes, including 24-hour mortality.

The study will enroll at least 550 adult ED patients requiring intubation and exhibiting PDA features (hypotension, hypoxemia, or acidosis). Patients intubated outside the ED, those in pre-intubation cardiac arrest, or those re-intubated within 24 hours will be excluded. The primary outcome is the incidence of PICI, defined by standardized criteria including sustained hypotension, new or increase in vasopressor requirement, or cardiac arrest within 30 minutes of intubation. Secondary outcomes include ICU/hospital length of stay and mortality at 24 hours, 7 days, and 28 days.

 
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