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CTRI Number  CTRI/2025/06/088408 [Registered on: 06/06/2025] Trial Registered Prospectively
Last Modified On: 04/06/2025
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   Comparison of two techniques of facemask ventilation (manual vs ventilator facemask ventilation) in obese patients undergoing surgery under general anaesthesia 
Scientific Title of Study   Comparison of Gastric Insufflation by Real-Time Ultrasonography with Manual Facemask Ventilation and Pressure Control Ventilation During Induction of General Anaesthesia in Obese Patients Undergoing Elective Surgeries: A Randomized Clinical 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 SHRIJITA CHOWDHURY 
Designation  JUNIOR RESIDENT 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of Anaesthesiology & Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvantry Nagar, Gorimedu, Puducherry
Department of Anaesthesiology & Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvantry Nagar, Gorimedu, Puducherry
Pondicherry
PONDICHERRY
605006
India 
Phone  9088379611  
Fax    
Email  shrijita.14apr@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Banupriya R 
Designation  Assistant Professor  
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of Anaesthesiology & Critical Care Jawaharlal Institute of Postgraduate Medical Education and Research Dhanvantry Nagar Gorimedu

Pondicherry
PONDICHERRY
605006
India 
Phone  9677629587  
Fax    
Email  banupriya147@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Banupriya R 
Designation  Assistant Professor  
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of Anaesthesiology & Critical Care Jawaharlal Institute of Postgraduate Medical Education and Research Dhanvantry Nagar Gorimedu

Pondicherry
PONDICHERRY
605006
India 
Phone  9677629587  
Fax    
Email  banupriya147@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Jawaharlal Institute of Postgraduate Medical Education and Research Puducherry 
Address  Jawaharlal Institute of Postgraduate Medical Education and Research Gorimedu Dhanvantry Nagar Puducherry- 605006 
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 SHRIJITA CHOWDHURY  JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL RESEARCH AND EDUCATION  DEPT OF ANAESTHESIOLOGY AND CRITICAL CARE JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL RESEARCH AND EDUCATION GORIMEDU, DHANVANTRI NAGAR PUDUCHERRY
Pondicherry
PONDICHERRY 
9088379611

shrijita.14apr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee- interventional studies, JIPMER, Puducherry  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E669||Obesity, unspecified, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Manual facemask ventilation  For facemask ventilation, the Adjustable Pressure Limiting valve (APL) will be kept at 20 cm H2O and adjusted to achieve a tidal volume target of 8 ml/kg (IBW- Ideal Body Weight) with a pressure limit of 30 cm H2O. The respiratory rate will be maintained at 12-15/min titrated to achieve EtCO2 of 35-40 mmHg. 
Intervention  Pressure Controlled Ventilation  For facemask ventilation, A pressure-controlled ventilation will be initiated with an initial inspiratory pressure of 15cm of H2O, respiratory rate of 12/min and PEEP of 5 cm of H2O. The inspiratory pressure will be adjusted up and down by 2 cm of H2O to achieve a target tidal volume of 8 ml/kg (IBW) with a maximum pressure limit of 30 cm of H2O. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details 
Patients more than 18 years of age, with BMI more
than 30 kg/m2 undergoing elective surgery under
general anaesthesia in JIPMER will be included in
this study 
 
ExclusionCriteria 
Details  1) Patients requiring rapid sequence intubation
(RSI)
2) Known or predicted respiratory disorder
3) Patients oropharyngeal or facial pathology
4) Patients with a nasogastric tube in situ
5) Gastrointestinal diseases such as intragastric
hypertension and intestinal obstruction 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the incidence of ‘comet-tail’ artefacts
using gastric antral ultrasonography in obese patients
between manual facemask ventilation and pressure controlled
ventilation during induction of general
anaesthesia 
During induction (3 minutes of facemask ventilation) 
 
Secondary Outcome  
Outcome  TimePoints 
Change in CSA measurements of gastric antrum   Pre and post induction 
Peak airway pressure, exhaled tidal volume , minute ventilation , EtCO2,   Every 30 seconds during 3 minutes of mask ventilation 
 
Target Sample Size   Total Sample Size="146"
Sample Size from India="146" 
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)   16/06/2025 
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  

The study will commence after obtaining approval from the Postgraduate Research Monitoring Committee (PGMRC), Institute Ethics Committee (IEC) and Clinical Trials Registry-India (CTRI) registration.

Informed and written consent will be obtained from all patients after the preoperative assessment. A baseline pre-induction gastric ultrasonography will be performed by the investigating anesthesiologist on the day of the surgery. The cross-sectional area of the gastric antrum will be measured by the free tracing method and a mean value of three readings will be noted. In the operating room, standard ASA monitors will be attached, and all patients will be pre-oxygenated with 100% oxygen with a fresh gas flow of 6L/minute with a 25-degree head-end elevation. The patients will be induced with Fentanyl (2 µg/kg), titrated dose of Propofol and atracurium (0.5 mg/kg)/vecuronium (0.1 mg/kg). Once the patient is induced, and check ventilation is confirmed, an appropriate size oropharyngeal airway (Guedel) will be inserted, and the facemask will be held against the patient’s face using a 2-handed technique. The patients according to the randomization will be ventilated as follows by the attending anaesthesiologist:

Group A- Manual Facemask ventilation: The Adjustable Pressure Limiting valve (APL) will be kept at 20 cm H2O and adjusted to achieve a tidal volume target of 8 ml/kg (IBW- Ideal Body Weight) with a pressure limit of 30 cm H2O. The respiratory rate will be maintained at 12-15/min titrated to achieve EtCO2 of 35-40 mmHg.

Group B-Pressure controlled ventilation: A pressure-controlled ventilation will be initiated with an initial inspiratory pressure of 15cm of H2O, respiratory rate of 12/min and PEEP of 5 cm of H2O. The inspiratory pressure will be adjusted up and down by 2 cm of H2O to achieve a target tidal volume of 8 ml/kg (IBW) with a maximum pressure limit of 30 cm of H2O. 

 In both groups, ventilation will be continued for 3 minutes. Simultaneously, the investigating anaesthesiologist will observe the occurrence of the comet-tail artefact by real-time gastric antral ultrasonography. The peak airway pressure, at the time of appearance of the comet tail artefact will be noted. The ventilating anaesthesiologist will be unaware of the ultrasound findings. After three minutes the airway will be secured with an endotracheal tube and will be secured after confirming the position. The investigating anaesthesiologist will repeat the gastric antral ultrasonography in the same site as marked and observe for the CSA. (An average of 3 recordings will be noted). Subsquent anaesthetic management will be left at the discretion of the concerned anaesthesiologist. 

 
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