| CTRI Number |
CTRI/2024/09/073191 [Registered on: 02/09/2024] Trial Registered Prospectively |
| Last Modified On: |
27/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Tracheal intubation in critically ill and its complication |
|
Scientific Title of Study
|
Prospective observational study to evaluate the immediate complications of endotracheal intubation in the intensive care unit |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mayur Gupta |
| Designation |
Senior Resident |
| Affiliation |
Shri Balaji Institute of Medical Sciences |
| Address |
Department of Critical Care Medicine, Fourth Floor, Shri Balaji Institute of Medical Sciences, Dubey Colony, Mova, Raipur, Chhattisgarh
Raipur
CHHATTISGARH
492001
India |
| Phone |
08770107359 |
| Fax |
|
| Email |
drmayurgupta@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prafulla Agnihotri |
| Designation |
Senior consultant |
| Affiliation |
Shri Balaji Institute of Medical Sciences |
| Address |
Department of Critical Care Medicine, Fourth Floor, Shri Balaji Institute of Medical Sciences, Dubey Colony, Mova, Raipur, Chhattisgarh
Raipur
CHHATTISGARH
492001
India |
| Phone |
9685699030 |
| Fax |
|
| Email |
prafullaagnihotri@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mayur Gupta |
| Designation |
Senior Resident |
| Affiliation |
Shri Balaji Institute of Medical Sciences |
| Address |
Department of Critical Care Medicine, Fourth Floor, Shri Balaji Institute of Medical Sciences, Dubey Colony, Mova, Raipur, Chhattisgarh
Raipur
CHHATTISGARH
492001
India |
| Phone |
08770107359 |
| Fax |
|
| Email |
drmayurgupta@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Shri Balaji Institute of Medical Sciences, Dubey Colony, Mova, Raipur, Chhattisgarh 492014 |
|
|
Primary Sponsor
|
| Name |
Shri Balaji Institute of Medical Sciences |
| Address |
Shri Balaji Institute of Medical Sciences, Dubey Colony, Mova, Raipur, Chhattisgarh 492014 |
| Type of Sponsor |
Private medical college |
|
|
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 Mayur Gupta |
Medical Intensive Care Unit |
Fourth Floor, Shri Balaji Institute of Medical Sciences, Dubey Colony, Mova, Raipur, Chhattisgarh 492014
Raipur
CHHATTISGARH |
8770107359
drmayurgupta@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethic Committee, Shri Balaji Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Endotracheal intubation. |
Traditional curved laryngoscope blades were used for intubation.. Atracuronium 0.5mg/kg and succinylcholine 2 mg/kg were used as neuromuscular blocking agents. Propofol 2mg/kg or midazolam 0.1mg/kg or ketamine 2mg/kg were used as sedative-hypnotics. All intubated patients were supervised using heart monitors and automatic, non-invasive blood pressure monitors. All intubated patients oxygen saturation levels were tracked using pulse oximeters. Before intubation, patients were routinely preoxygenated. Endotracheal intubation success was evaluated using colorimetric end-tidal CO2 detection. To locate the end of the endotracheal tube, chest auscultation was performed. After intubation, chest x-rays were taken. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
We will include all adult (≥ 18 years old) critically ill patients undergoing intubation in medical intensive care unit during the period of observation. We will define critically ill those patients with a life-threatening condition requiring intubation for either respiratory failure or airway protection |
|
| ExclusionCriteria |
| Details |
Intubation performed in the emergency room, ward and operation theater.
Intubation performed in the out-of-hospital setting
Intubation in patients with cardiac arrest
Intubation performed only for anesthesia (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 complications associated with endotracheal intubation (ETI) performed in the intensive care unit (ICU) |
30 Minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Difficult intubation
Cannot intubate cannot ventilate
Cardiac arrhythmia
Aspiration
Esophageal intubation
Pneumothorax |
30 Minutes |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/09/2024 |
| 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="2"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
CRITICALLY ILL PATIENTS FREQUENTLY REQUIRE TRACHEAL INTUBATION IN THE INTENSIVE CARE UNIT. CRITICALLY ILL PATIENTS OFTEN PRESENTS WITH SEVERE RESPIRATORY FAILURE, HEMODYNAMIC INSTABILITY, CARDIAC AND CEREBROVASCULAR DISEASE AND RECENT FOOD INTAKE WHICH MAKE THEN PHYSIOLOGICALLY DIFFICULT INTUBATION. AIRWAY MANAGEMENT IN INTENSIVE CARE UNIT IS ASSOCIATED WITH HIGHER INCIDENCE OF SEVERE HYPOXIA, HEMODYNAMIC COLLAPSE, CARDIAC ARREST AND DEATH. LIMITED INFORMATION IS AVALIABLE ON ADVERSE PERI-INTUBATION EVENTS. WE AIM TO EVALUATE THE INCIDENCE AND NATURE OF ADVERSE PERI-INTUBATION ADVERSE EVENTS.
|