| 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
|
|
|
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
|
|
|
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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