| CTRI Number |
CTRI/2024/02/062217 [Registered on: 01/02/2024] Trial Registered Prospectively |
| Last Modified On: |
23/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Safety of using reduced oxygen concentration during administration of anaesthesia prior to surgery |
|
Scientific Title of Study
|
Safety of Pre-oxygenation with 50% oxygen- A Randomized Control Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jithin Mathew Abraham |
| Designation |
Professor |
| Affiliation |
Believers Church Medical College Hospital |
| Address |
Department of Anaesthesiology,Believers Church Medical College Hospital,St Thomas Nagar,Kuttapuzha,Thiruvalla
Pathanamthitta
KERALA
689103
India |
| Phone |
9446765053 |
| Fax |
|
| Email |
jithinmab@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jithin Mathew Abraham |
| Designation |
Professor |
| Affiliation |
Believers Church Medical College Hospital |
| Address |
Department of Anaesthesiology,Believers Church Medical College Hospital,St Thomas Nagar,Kuttapuzha,Thiruvalla
Pathanamthitta
KERALA
689103
India |
| Phone |
9446765053 |
| Fax |
|
| Email |
jithinmab@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jithin Mathew Abraham |
| Designation |
Professor |
| Affiliation |
Believers Church Medical College Hospital |
| Address |
Department of Anaesthesiology,Believers Church Medical College Hospital,St Thomas Nagar,Kuttapuzha,Thiruvalla
Pathanamthitta
KERALA
689103
India |
| Phone |
9446765053 |
| Fax |
|
| Email |
jithinmab@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology,
Believers Church Medical College Hospital,St Thomas Nagar,Kuttapuzha,Thiruvalla 689103,Kerala |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
Believers Church Medical College Hospital,St Thomas Nagar,Kuttapuzha,Thiruvalla 689103,Kerala |
| 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 Jithin Mathew Abraham |
Believers Church Medical College Hospital |
Department of Anaesthesiology, St Thomas Nagar,Kuttapuzha,Thiruvalla 689103
Pathanamthitta
KERALA |
9446765053
jithinmab@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,BELIEVERS CHURCH MEDICAL COLLEGE HOSPITAL |
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 |
| Comparator Agent |
GROUP 100 |
Patient will be pre- oxygenated with 100% oxygen for three minutes prior to induction of anaesthesia |
| Intervention |
GROUP 50
|
Patient will be pre- oxygenated with 50% oxygen for three minutes prior to induction of anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to ASA PS classes I and II posted for elective non cardiac surgeries under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Following patients will be excluded
ASA PS classes III and IV
Emergency surgeries
Anticipated difficult airway
Cardiac, neurological and thoracic surgeries
Pregnant and obese patients
Full stomach
Lack of consent
Preoperative saturation less than 96 percent
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| % OF PATIENTS WITH DESATURATION |
FROM START OF PREOXYGENATION TILL INTUBATION |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. TIME TAKEN FOR INTUBATION
2. HEMODYNAMIC VARIATIONS DURING INTUBATION
3. EXPIRED OXYGEN CONCENTRATION DURING THE FIRST FIVE MINUTES OF PREOXYGENATION |
FROM START OF PREOXYGENATION TILL 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)
|
05/02/2024 |
| 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="0"
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
|
Preoxygenation is the initiation of oxygenation prior to induction of general anaesthesia and tracheal intubation. Traditional practice of preoxygenation is done with 100% oxygen at 6-10 L/min of oxygen flow for 3-5 minutes. This helps to increase the safe apnea time for intubation. This practice results in wastage of oxygen as well could cause problems of oxygen toxicity. This study aims to establish the safety of using 50% oxygen during preoxygenation in ASA I and II patients without anticipated difficult airway. The intubation will be done by anaesthesiologists with over five years of experience.
Patients fulfilling inclusion criteria will be randomised to receive either 100% or 50% oxygen during preoxygenation. The vitals (heart rate, blood pressure and saturation) and the expired oxygen concentration will be monitored at specified time intervals. The time to intubation and any oxygenation/airway related incidents will be noted. At any time point, if there is a difficulty with mask ventilation/ intubation in those receiving 50% oxygen, they will be administered 100% oxygen. |