| CTRI Number |
CTRI/2024/05/066963 [Registered on: 07/05/2024] Trial Registered Prospectively |
| Last Modified On: |
06/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of three methods of pre oxygenation - a randomised controlled trial |
|
Scientific Title of Study
|
Denitrogenation: comparison of three methods of preoxygenation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kavya Pinto |
| Designation |
Junior resident |
| Affiliation |
St John’s National academy of health sciences |
| Address |
Dept of Anaesthesiology,
St John’s medical college hospital,
Sarjapur Road, Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
9632669565 |
| Fax |
|
| Email |
kavya.pinto@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Savitha KS |
| Designation |
Professor |
| Affiliation |
St John’s National academy of health sciences |
| Address |
Department of Anaesthesiology,
St John’s medical college hospital,
Sarjapur Road, Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
9844638121 |
| Fax |
|
| Email |
drsavitha_ks@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Kavya Pinto |
| Designation |
Junior resident |
| Affiliation |
St John’s National academy of health sciences |
| Address |
Department of Anaesthesia,
St John’s medical college hospital,
Sarjapur Road, Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
9632669565 |
| Fax |
|
| Email |
kavya.pinto@yahoo.com |
|
|
Source of Monetary or Material Support
|
| St Johns National Academy of Health Sciences |
|
|
Primary Sponsor
|
| Name |
St Johns National Academy of Health Sciences |
| Address |
Department of Anaesthesiology,
St Johns National Academy of Health Sciences,
Sarjapur Road, Bangalore - 560034,
Karnataka, India. |
| 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 Kavya Pinto |
St John’s medical college hospital |
Department of Anaesthesia,
St Johns Medical College hospital,
Sarjapur Road, Bangalore - 560034,
Karnataka, India
Bangalore
KARNATAKA |
9632669565
kavya.pinto@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, St John’s 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 |
| Intervention |
4 room air vital capacity breaths followed by preoxygenation |
General Electronics Avance CS2 work station with circle breathing system having a 2L capacity reservoir bag will be used. Patients will be supine with a 20 degree head up position, patient will be instructed to take 4 room air vital capacity breaths followed by transparent anaesthetic face mask held with air tight seal with FGF of 10L/min and FiO2 of 1. Time taken and number of breaths to reach EtO2 of 0.9 will be recorded |
| Comparator Agent |
Preoxygenation by tidal volume breathing for 3 minutes |
General Electronics Avance CS2 work station with circle breathing system having a 2L capacity reservoir bag will be used. Patients will be supine with a 20 degree head up position, transparent anaesthetic face mask held with air tight seal with FGF of 10L/min and FiO2 of 1 for full 3 minutes of preoxygenation, as is the standard method |
| Intervention |
Preoxygenation with CPAP of 5cm H2O |
General Electronics Avance CS2 work station with circle breathing system having a 2L capacity reservoir bag will be used. Patients will be supine with a 20 degree head up position, transparent anaesthetic face mask held with air tight seal with FGF of 10L/min and FiO2 of 1 and CPAP of 5cmH2O. Time taken and number of breaths to reach EtO2 of 0.9 will be recorded |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Adults (ages 18-50)
Both sexes
ASA grade I and II
Elective surgeries under general anaesthesia
|
|
| ExclusionCriteria |
| Details |
Recent respiratory infection
Chronic smokers
Asthmatics
Anticipated difficult airway
Pregnant women
BMI more than 30kg/m2
Cardiac/respiratory diseases
Patients who do not consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total time taken, number of breaths to reach EtO2 of 0.9 |
0,1,2,3 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of breaths required to reach EtO2 of 0.9 |
0,30s,1min,1.5 min, 2 min, 2.5 min, 3 min |
|
|
Target Sample Size
|
Total Sample Size="69"
Sample Size from India="69"
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)
|
06/06/2024 |
| 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="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
|
Preoxygenation is standard protocol before the onset of general anaesthesia. If we are able to find a way to increase efficiency and efficacy, it would save the anaesthetist both time and energy and reduce the rush to secure an airway. Aim of the study is to assess the clinical efficacy of different methods of pre oxygenation with gas monitoring using an advanced workstation. Primary objective: To compare the time taken and total number of breaths required to achieve EtO2 of 0.9 with delivery of fresh gas flow of 10L of oxygen between group A, group B and group C. Group A: Conventional method, preoxygenation with tidal breaths for three minutes, with FiO2 of 1 Group B: Pre oxygenation with tidal breathing applying continuous positive airway pressure (CPAP) of 5 cm H2O Group C: Pre oxygenation with tidal breaths following four room air vital capacity breaths in 30 seconds Secondary objective: To assess the time taken for decline in EtO2 to 0.5 in group A, group B, group C
Inclusion Criteria: ASA I and II patients, Adults aged 18-59, Both gender, Patients undergoing elective surgery under any form of anaesthesia Exclusion criteria: Anticipated difficult airway, Chronic smokers, Asthmatics, BMI >30kg/m2, Pregnant women, Cardiac/respiratory diseases, Patients who do not consent General Electronics Avance CS2 work station with circle breathing system having a 2L capacity reservoir bag will be used. Patients taking part in the study will be given anxiolytic Alprazolam 0.25mg HS. Prior to preoxygenation, baseline RR and EtO2 will be documented. Patients will be supine with a 20 degree head up position, transparent anaesthetic face mask held with air tight seal with FGF of 10L/min and FiO2 of 1. During the denitrogenation process, the total time taken along with number of breaths will be recorded. Exhaled tidal volume, EtCo2, FiO2, and ETO2 will be recorded after each breath. After this process, fresh gas flow will be switched to 100% air. Total time taken and number of breaths required to record a drop in ETO2 to 0.5 will be recorded. Data will be analysed using SPSS 2021. Descriptive statistics will be reported using mean and SD for continuous variables and numbers and percentages for categorical variables |