| 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
|
|
|
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
|
|
|
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
|
|
|
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. |