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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 25head 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 PAOto 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.

 
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