FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/06/088736 [Registered on: 12/06/2025] Trial Registered Prospectively
Last Modified On: 09/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A COMPARATIVE STUDY OF PRE OXYGENATION BETWEEN PRESSURE SUPPORT WITH POSITIVE END EXPIRATORY PRESSURE, USING PRESSURE SUPPORT VENTILATION AND SPONTANEOUS BREATHUNG WITH FACE MASK DURING GENERAL ANAESTHESIA IN PATIENTS UNDERGOING SURGERY UNDER GENERAL ANAESTHESIA TO COMPARE SAFE APNEA TIME 
Scientific Title of Study   A COMPARATIVE STUDY OF PRE OXYGENATION WITH PRESSURE SUPORT VENTILATION , PRESSURE SUPPORT VENTILATION WITH THE POSITIVE END-EXPIRATORY PRESSURE, AND SPONTANEOUS BREATHING WITH FACE MASK DURING GENERAL ANAESTHESIA 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  MADHU MANOHAR V 
Designation  POST GRADUATE JUNIOR RESIDENT 
Affiliation  Srinivas Institute of Medical sciences and Research Centre 
Address  DEPARTMENT OF ANAESTHESIA, SRINIVAS INSTITUTE OPF MEDICAL SCIENCES AND RESEARCH CENTRE, MANGALORE - 575021
Srinivas Institute of Medical sciences and Research Centre, Mukka, Surathkal, Mangalore - 575021
Dakshina Kannada
KARNATAKA
575021
India 
Phone  7736572616  
Fax    
Email  madhumanoharv@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR BARBARA COELHO  
Designation  PROFESSOR 
Affiliation  Srinivas Institute of Medical sciences and Research Centre 
Address  Dept. Of Anaesthesia ,Srinivas Institute of Medical sciences and Research Centre, Mukka, Surathkal, Mangalore
Srinivas Institute of Medical sciences and Research Centre, Mukka, Surathkal, Mangalore - 575021
Dakshina Kannada
KARNATAKA
575021
India 
Phone  9901243519  
Fax    
Email  babcoelho@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR RAMESH PRABHU 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Srinivas Institute of Medical sciences and Research Centre 
Address  Dept. Of Anaesthesia ,Srinivas Institute of Medical sciences and Research Centre, Mukka, Surathkal, Mangalore
Srinivas Institute of Medical sciences and Research Centre, Mukka, Surathkal, Mangalore - 575021
Dakshina Kannada
KARNATAKA
575021
India 
Phone  6363246704  
Fax    
Email  rameshkunjarga@gmail.com  
 
Source of Monetary or Material Support  
SRINIVAS INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE 
 
Primary Sponsor  
Name  MADHU MANOHAR V 
Address  Srinivas Institute of Medical sciences and Research Centre, Mukka, Surathka, Mangalore - 575021  
Type of Sponsor  Other [SELF] 
 
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 PRASHANTH KUMAR HOD  Srinivas Institute of Medical sciences and Research Centre  DEPARTMENT OF ANESTHESIA, OPERATION THEATRE COMPLEX, GROUND FLOOR
Dakshina Kannada
KARNATAKA 
9738400843

drprashanthkumarc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRINIVAS INSTITUTE ETHICS COMMITTEE/ SRINIVAS INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Preoxygenation with Pressure Support Ventilation  Preoxygenation with PSV (FiO2-1, face mask, PSV OF 10 CmH20 ) 
Intervention  Preoxygenation with Pressure Support Ventilation and Positive End Expiratory Pressure  Preoxygenation with PSV and PEEP (FiO2-1, face mask, PSV OF 10 CmH20,PEEP of 8 CmH20) 
Comparator Agent  Standard preoxygenation   Spontaneous breathing with face mask) (FiO2-1, face mask, 10L 02 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients belonging to age group 18to 65 years undergoing elective operative procedure under general anesthesia.
2. ASA grade 1 and grade 2
3. Patients Room air peripheral oxygen saturation of more than 97%
4. Body mass index (BMI) of 18 to 26.0 kg per metre square 
 
ExclusionCriteria 
Details  1.Patients with history of respiratory disease
2.Patients having lesions / tumours of tracheobronchial tree and upper airway.
3.Patients with history of cardiac disorder affecting the effort tolerance
4.Patients with history of neurological disorder and neuromuscular disorders
5.Patients with anticipated difficult intubation.
6.Patients posted for emergency surgeries
7.Pregnant patients and patients with risk of aspiration 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. In all three groups time taken for desaturation till 92% of SpO2 (IN SECONDS)
will be recorded .
2. Heamodynamic parameters (HR, NIBP) will be recorded 
AT BASELINE 
 
Secondary Outcome  
Outcome  TimePoints 
Heamodynamic parameters (HR, NIBP) will be recorded  MEASUREMENT ET EVERY MIUTE TILL SPO2 REACHES 92% AND AFTER 2 MINUTES OF VENTILATION LATER 
 
Target Sample Size   Total Sample Size="105"
Sample Size from India="105" 
Final Enrollment numbers achieved (Total)= "105"
Final Enrollment numbers achieved (India)="105" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   20/06/2025 
Date of Study Completion (India) 09/12/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [madhumanoharv@gmail.com].

  6. For how long will this data be available start date provided 01-06-2025 and end date provided 01-10-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

1. Among the pool of eligible candidates, after taking written informed consent

from study participants ,105 subjects will be selected randomly and will be

allotted into 3 groups, group I, group II and group III.( A simple randomisation

technique will be followed. A total of 105 random numbers will generated at the

beginning of the study and kept centrally with the study guide. While participants

will be kept blind to the procedure and group allocation, the same is not feasible

for the investigators due to the inherent nature of the interventions. Although the

statistician who performs the data analysis will be blind to the intervention, the

master chart and statistical review were also conducted by the study guide, who

will not blind to the intervention. )

2. Once the subject is allocated to either of the three group, the subject will

continue to participate in the study.In the operating room, patients will be

positioned supine with their neck flexed and head extended. The American

Society of Anaesthesiologists (ASA) standard monitoring will be applied , and

pulse-oximetry of the same make will be used in all patients. Group allocation

will be disclosed to the intraoperative anesthesia team at this point.

3. GA induction will be standardised. Fresh gas flow will be set at 10L/

min.Patient will be pre oxygenated for 3 minutes from this point by any of the

following methods in which they are allocated.

4. Group I - The group with Facemask (with fresh gas flow of 10L/min and FiO2

100), patients will be breathing spontaneously with tidal volume breathing,

without bagging or pressure support .

5. Group II - In the PSV group, the PSV will be given using BPL E-FLO 6C

Anesthesia Machine and circle absorbent system with face mask. Pressure

support of 10CmH2O and FIO2 100.6. Group III- In the PSV +PEEP group settings of PSV 10CMH2O, PEEP of 8

CmH2O, FIO2 100.

7. After three minutes of pre oxygenation patient will be induced with propofol

(1.5-2.5 mg/Kg) bolus dose followed by propofol infusion of 200mcg/kg/min).

8. Two check ventilation breath will be performed to ensure that the patient is

able to be ventilated - Vecuronium 0.1 mg/Kg will be administered and facemark

will be removed from patient.

9. From this point ,time taken for desaturation till 92% of SpO2 (IN SECONDS)

will be recorded . Heamodynamic parameters (HR, NIBP) will be recorded. After

SpO2 reaches 92% , patients will be mask ventilated for 2 minutes, followed by

endotracheal intubation or supraglottic airway insertion will be performed and

anesthesia will be continued as per plan. .

10. The correct placement of the ET tube will be confirmed by capnography and

five-point auscultation (five breaths). After this, standard management will be

followed for both ventilation and peri-operative management as per protocol for

all three groups.

11.Heamodynamic parameters will be recorded at the beginning of

preoxygeantion, at the end of pre oxygenation, at the end of safe apnea period

and 2 minutes after ventilation later.

12.The statistical analysis will be done by appropriate statistical methods like

mean,percentages, standard deviation, Chi-square test and other relevant type of

statistical tests depending upon the type of data collected.

 
Close