| CTRI Number |
CTRI/2024/01/061870 [Registered on: 25/01/2024] Trial Registered Prospectively |
| Last Modified On: |
25/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
problems occuring in very sick patients while placing a tube for ventilation |
|
Scientific Title of Study
|
Major Adverse Peri-Intubation events during intubation of critically ill patients - A prospective observational study in south Asian population |
| Trial Acronym |
Not applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr J Kavitha |
| Designation |
Additional Professor |
| Affiliation |
Nizams Institute of Medical Sciences |
| Address |
Dept of Anesthesia and Intensive Care
Nizams Institute of Medical Sciences, Punjagutta, Hyderabad
Hyderabad
TELANGANA
500082
India |
| Phone |
8143769301 |
| Fax |
|
| Email |
drkarunya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr J Kavitha |
| Designation |
Additional Professor |
| Affiliation |
Nizams Institute of Medical Sciences |
| Address |
Dept of Anesthesia and Intensive Care
Nizams Institute of Medical Sciences, Punjagutta, Hyderabad
TELANGANA
500082
India |
| Phone |
8143769301 |
| Fax |
|
| Email |
drkarunya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Padmaja Durga |
| Designation |
Professor |
| Affiliation |
Nizams Institute of Medical sciences |
| Address |
Dept of Anesthesia and Intensive Care
Nizams Institute of Medical Sciences, Punjagutta, Hyderabad
Hyderabad
TELANGANA
500082
India |
| Phone |
9440387299 |
| Fax |
|
| Email |
padmajanims@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Nizams Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Nizams Institute of Medical Sciences |
| Address |
Dept of Anesthesia and Intensive Care
Nizams Institute of Medical Sciences, Punjagutta, Hyderabad |
| 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 Somavenkata Krishna |
Nizams Institute of Medical Sciences |
Dept of Anesthesia and Intensive Care
Nizams Institute of Medical Sciences, Punjagutta, Hyderabad
Hyderabad
TELANGANA |
8500031880
somakrishna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nizams Institutional Ethics Committee |
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 |
None |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Critically ill patients with life threatening impairment requiring endotracheal intubation
2. In-hospital emergency intubations occurring in EMD, ICU, wards |
|
| ExclusionCriteria |
| Details |
1. Patients who underwent out of hospital intubation
2. Intubations following cardiac arrest
3. Patients with saturations less than 80% at the end of preoxygenation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the incidence of major adverse peri-intubation events defined as severe hypoxemia SpO2 less than 80%, Cardiac arrest, Cardiovascular instability, new requirement for or increase in vasopressors |
Baseline, At the time of intubation and 10 minutes later |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Incidence of cardiac arrhythmias
2. Incidence of difficult intubation
3. Pulmonary aspiration
4. Oesophageal intubation
5. Airway injury
6. Cannot intubate cannot ventilate scenarios |
Baseline, during intubation & 10 minutes after intubation |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
14/02/2024 |
| 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="1"
Months="0"
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
|
This study is designed to assess the incidence and types of major adverse peri-intubation events in critically ill patients with appropriate inclusion and exclusion criteria. All the patients intubated under anesthesia residents will be included and data taken from medical records for a period of one year. Parameters studied will be reason for intubation,intubator details, complications present during assessment, hemodynamics in peri-intubation period, respiratory status, method of preoxygenation, drugs used for intubation, equipment, success rate of intubation, complications. Statistical analysis will be performed using SPSS version 24 |