CTRI Number |
CTRI/2017/05/008498 [Registered on: 05/05/2017] Trial Registered Retrospectively |
Last Modified On: |
24/04/2017 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cohort Study |
Study Design |
Randomized, Crossover Trial |
Public Title of Study
|
comparing normal breathing for 3 minutes and 8 deep breaths in 1 minute to achieve better oxygenation before giving general anaesthesia |
Scientific Title of Study
|
a prospective, randomized controlled, crossover study of effectiveness of two preoxygenation techniques : breathing 100% oxygen at 8 vital capacity breaths in 1 minute vs tidal volume breathing for 3 minutes in patients undergoing elective surgery under general anaesthesia |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Anjali Pingle |
Designation |
consultant anaesthesiologist |
Affiliation |
P D Hinduja National Hospital and MRC |
Address |
anaesthesiaa office, department of anaesthesiology, 3rd floor, new building, Veer Savarkar Marg,
Mahim, Mumbai - 400016
Maharashtra
Mumbai (Suburban) MAHARASHTRA 400016 India |
Phone |
9833733915 |
Fax |
|
Email |
dranjalipingle@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Anjali Pingle |
Designation |
consultant anaesthesiologist |
Affiliation |
P D Hinduja National Hospital and MRC |
Address |
anaesthesiaa office, department of anaesthesiology, 3rd floor, new building, Veer Savarkar Marg,
Mahim, Mumbai - 400016
Maharashtra
Mumbai (Suburban) MAHARASHTRA 400016 India |
Phone |
9833733915 |
Fax |
|
Email |
dranjalipingle@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Anup Nawal |
Designation |
clinical assisstant |
Affiliation |
P D Hinduja National Hospital and MRC |
Address |
anaesthesiaa office, department of anaesthesiology, 3rd floor, new building, Veer Savarkar Marg,
Mahim, Mumbai - 400016
Maharashtra
Mumbai (Suburban) MAHARASHTRA 400016 India |
Phone |
8600013430 |
Fax |
|
Email |
anupnawaldr@gmail.com |
|
Source of Monetary or Material Support
|
P D Hinduja National Hospital and MRC, Veer Savarkar Marg, Mahim,Mumbai, Maharashtra - 400016 |
|
Primary Sponsor
|
Name |
P D Hinduja National Hospital and MRC |
Address |
Veer Savarkar Marg,
Mahim, Mumbai - 400016
Maharashtra |
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 Anjali Pingle |
P D Hinduja National Hospital and MRC |
anaesthesia office, anaesthesia department,
3rd floor, new building,
Veer Savarkar Marg,
Mahim - 400016 Mumbai (Suburban) MAHARASHTRA |
9833733915
dranjalipingle@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Review Board |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
preoxygenation / denitrogenation, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
3 minutes tidal volume breathing |
patient is asked to breath 100% oxygen through a closed circuit and tight fitting mask for 3 minutes at normal tidal volume and rate |
Intervention |
8 vital capacity breaths |
patient is asked to breath 100% oxygen through closed circuit and tight fitting mask for 8 deep vital capacity breaths |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
ASA physical status I and II patients posted for elective surgery under general anaesthesia |
|
ExclusionCriteria |
Details |
1.pre existing respiratory or cardiac diseases
2.anticipated difficult airway
3.pregnancy
4.anticipated difficult mask ventilation
5.uncooperative patients
6.claustrophobia
7.patient refusal |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
To identify which technique of preoxygenation : 3 minutes tidal volume breathing and eight vital capacity breaths, is effective across the study group. |
3 minutes for tidal volume breathing and 8 vital capacity breaths |
|
Secondary Outcome
|
Outcome |
TimePoints |
To identify which technique of preoxygenation : 3 minutes tidal volume breathing and eight vital capacity breaths, is effective in overweight and obese patients. |
3 minutes for tidal volume breathing and 8 vital capacity breaths |
|
Target Sample Size
|
Total Sample Size="270" Sample Size from India="270"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
01/01/2015 |
Date of Study Completion (India) |
Date Missing |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="0" Months="8" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
Not published |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
This was a prospective, randomized, crossover study comparing two preoxygenation techniques: eight vital capacity (VC) breaths vs. three minutes tidal volume (TV) breaths in 270 patients undergoing elective surgery under general anaesthesia. It was a single centre study conducted at P. D. Hinduja National Hospital and Medical Research Centre, Mumbai. The primary outcome is to identify which of the two techniques of preoxygenation is effective across the study group. The secondary outcome is to identify the effectiveness of either technique of preoxygenation in overweight and obese patients. As it was a crossover study all patients underwent both techniques of preoxygenation. However, the patients were randomized to either perform the TV or VC maneuver first. This randomization into two groups was done by a computer generated sequence of random numbers. All the patients were given a 250 head up position for both the techniques. Patients assigned to Group One were instructed to breathe at normal TV for 3 min through a close fitting mask. Over the next ten minutes the patients breathed room air to allow the PAO2 to come back to baseline before crossing over to VC breathing. Patients assigned to Group Two were first instructed to take eight VC breaths, followed by ten minutes of room air breathing before they crossed over to the TV breathing. Preoxygenation was carried out with 15 L/min of FGF with FiO2 of 1.0 using the circle system. The ETO2 achieved was sampled at the patient end, on completion of each technique. After data collection, data entry was done in Excel. Data analysis was done using SPSS Software version 20.0. |