| CTRI Number |
CTRI/2026/01/102257 [Registered on: 28/01/2026] Trial Registered Prospectively |
| Last Modified On: |
27/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing machine-controlled breathing and hand-controlled breathing during the start of general anaesthesia, to see their effects on lung pressure and the risk of air going into the stomach |
|
Scientific Title of Study
|
COMPARISON OF EFFECTS OF PRESSURE-CONTROLLED VENTILATION AND MANUAL VENTILATION ON PEAK AIRWAY PRESSURE AND GASTRIC INSUFFLATION DURING INDUCTION OF GENERAL ANAESTHESIA–A RANDOMISED CONTROL STUDY |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Darshan Gowda G S |
| Designation |
Junior resident |
| Affiliation |
Shri B.M. Patil Medical College Hospital and Research Centre |
| Address |
Department of Anaesthesiology, Shri B.M. Patil Medical College Hospital and Research Centre,Vijayapura ,Karnataka
Bijapur
KARNATAKA
586103
India |
| Phone |
9008876997 |
| Fax |
|
| Email |
darshansrinivas007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Renuka Holyachi |
| Designation |
Professor, Head of the department of Anaesthesiology |
| Affiliation |
Shri B.M. Patil Medical College Hospital and Research Centre |
| Address |
Department of Anaesthesiology, Shri B.M. Patil Medical College Hospital and Research Centre,Vijayapura ,Karnataka
Bijapur
KARNATAKA
586103
India |
| Phone |
9008876997 |
| Fax |
|
| Email |
renuka312@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Darshan Gowda G S |
| Designation |
Junior resident |
| Affiliation |
Shri B.M. Patil Medical College Hospital and Research Centre |
| Address |
Department of Anaesthesiology, Shri B.M. Patil Medical College Hospital and Research Centre,Vijayapura ,Karnataka
Bijapur
KARNATAKA
586103
India |
| Phone |
9008876997 |
| Fax |
|
| Email |
darshansrinivas007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Shri B.M. Patil Medical College Hospital and Research Centre,Vijayapura ,Karnataka |
|
|
Primary Sponsor
|
| Name |
Shri BM Patil Medical College Hospital and Research Centre |
| Address |
Department of Anaesthesiology, Shri B.M. Patil Medical College Hospital and Research Centre, Vijayapura ,Karnataka 586103 |
| Type of Sponsor |
Private medical college |
|
|
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 Darshan Gowda G S |
Shri B.M. Patil Medical College Hospital and Research Centre |
Department of Anaesthesiology, 3rd floor, Shri B.M. Patil Medical College Hospital and Research Centre, Vijayapura, Karnataka
Bijapur
KARNATAKA |
09008876997
darshansrinivas007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri BM Patil Medical College Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comparison of the effects of manual ventilation on peak airway pressure and gastric insufflation during induction of general anaesthesia |
Comparison of the effects of manual ventilation on peak airway pressure and gastric insufflation using usg and etco2 during induction of general anaesthesia |
| Intervention |
Comparison of the effects of pressure-controlled ventilation on peak airway pressure and gastric insufflation during induction of general anaesthesia |
Comparison of the effects of pressure-controlled ventilation on peak airway pressure and gastric insufflation using usg and etco2 during induction of general anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients aged 18 to 60 years receiving elective procedures under general anaesthesia.
2.Patients were classed as American Society of Anaesthesiologists (ASA) 1 and 2 following a complete pre-anaesthetic examination.
|
|
| ExclusionCriteria |
| Details |
1.Patient refusal.
2.Pregnant woman.
3.Patients having a BMI of 30 kg/m2 or higher.
4.Patients with anticipated difficult airway
5.Patients with oropharyngeal/facial pathologies
6.Patients who actively smoke |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare Peak Airway Pressure between Pressure Control Ventilation and Manual Ventilation during induction of general Anaesthesia |
Compare Peak Airway Pressure between Pressure Control Ventilation and Manual Ventilation during induction of general Anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•Compare End Tidal CO2 levels between Pressure Control Ventilation & Manual Ventilation during anesthesia induction.
•To compare gastric insufflation rates during anaesthesia induction using Pressure Control Ventilation & Manual Ventilation methods
|
EtCo2 0 seconds,30 seconds ,60 seconds ,90 seconds ,120 seconds ,180 seconds
gastric insufflation at 0seconds & 180 seconds |
|
|
Target Sample Size
|
Total Sample Size="153"
Sample Size from India="153"
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)
|
09/02/2026 |
| 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="1"
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
|
This study is a prospective, randomized controlled trial designed to compare the effects of pressure-controlled ventilation (PCV) and manual ventilation (MV) on peak airway pressure and gastric insufflation during induction of general anaesthesia. Facemask ventilation is a critical component of airway management during induction; however, excessive airway pressure may lead to gastric insufflation, increasing the risk of regurgitation and aspiration. A total of 154 adult patients scheduled for elective surgeries under general anaesthesia will be randomly allocated into two groups: Group PCV (pressure-controlled ventilation) and Group MV (manual ventilation). After standard induction of anaesthesia and neuromuscular blockade, patients will receive mask ventilation for 180 seconds according to their allocated group. Peak airway pressure, end-tidal carbon dioxide, oxygen saturation, heart rate, and mean arterial pressure will be recorded at 30-second intervals. Gastric insufflation will be assessed using epigastric auscultation and ultrasonography. The primary outcome is comparison of peak airway pressure between the two ventilation techniques. The secondary outcome is the incidence of gastric insufflation during mask ventilation. This study aims to determine whether pressure-controlled ventilation provides safer airway dynamics and reduces gastric insufflation compared to manual ventilation during induction of general anaesthesia. |