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CTRI Number  CTRI/2024/08/072199 [Registered on: 09/08/2024] Trial Registered Prospectively
Last Modified On: 04/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing effects of Volume Control Ventilation vs Manual Ventilation on the Airway Dynamics during Induction of General Anesthesia  
Scientific Title of Study   The Comparative study of effects of Volume Control Ventilation and Manual Ventilation on the Airway Dynamics during induction of General Anaesthesia : A Prospective 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  Dr G K ANKUSH 
Designation  Post-graduate 
Affiliation  Rajarajeswari Medical College And Hospital , Bangalore 
Address  Department of Anaesthesiology , RajaRajeswari Medical College And Hospital, No 202 , Kambipura, Mysore Road, Bangalore 560074, Karnataka, India.

Bangalore
KARNATAKA
560074
India 
Phone  7338120305  
Fax    
Email  28121998gkankush@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr MAHESH CHANDRA 
Designation  Associate Professor 
Affiliation  Rajarajeswari Medical College And Hospital , Bangalore 
Address  Department of Anaesthesiology , RajaRajeswari Medical College And Hospital, No 202 , Kambipura, Mysore Road, Bangalore 560074, Karnataka, India.

Bangalore
KARNATAKA
560074
India 
Phone  9483251081  
Fax    
Email  mahesh324@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr MAHESH CHANDRA 
Designation  Associate Professor 
Affiliation  Rajarajeswari Medical College And Hospital , Bangalore 
Address  Department of Anaesthesiology , RajaRajeswari Medical College And Hospital, No 202 , Kambipura, Mysore Road, Bangalore 560074, Karnataka, India.

Bangalore
KARNATAKA
560074
India 
Phone  9483251081  
Fax    
Email  mahesh324@gmail.com  
 
Source of Monetary or Material Support  
Rajarajeswari Medical College And Hospital, No 202, Kambipura, Mysore Road, Bangalore 560074, Karnataka, India. 
 
Primary Sponsor  
Name  Rajarajeswari Medical College And Hospital Bangalore 
Address  No 202 , Kambipura, Mysore Road, Bangalore 560074, Karnataka, India 
Type of Sponsor  Private medical college 
 
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 G K ANKUSH  Rajarajeswari Medical College And Hospital   2nd Floor Hospital Building , Department of Anaesthesiology , Rajarajeswari Medical College And Hospital, No 202, Kambipura, Mysore Road, Bangalore 560074, Karnataka, India.
Bangalore
KARNATAKA 
7338120305

28121998gkankush@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RRMCH Institutional Ethics Committee  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 
Comparator Agent  Manual Ventilation  Patients will receive Manual ventilation via a 2 L reservoir bag in the circle system of the GE CARESTATION 650 A1 Anaesthesia Machine , with a fresh gas flow of 10L/min and Adjustable pressure limiting valve adjusted to 20 cm H2O during induction of General Anaesthesia. 
Intervention  Volume Control Ventilation  Patients will receive Volume Control Ventilation via the GE CARESTATION 650 A1 Anaesthesia Machine, with Tidal Volume set at 6-8 ml/kg body weight , Respiratory Rate of 14 and Inspiratory : Expiratory ratio of 1:2 during induction of General Anaesthesia. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Patients of age group 18 to 60 years, undergoing elective surgeries under general anaesthesia, from different departments.
2)Patients classified under American Society of Anaesthesiologists (ASA) 1 and 2 after thorough Pre-
Anaesthetic evaluation 
 
ExclusionCriteria 
Details  1)Patient refusal
2)Pregnant women
3)Patients with BMI of 30kg/m2 and more
4)Patients undergoing emergency surgeries
5)Patients with anticipated difficult airway Mallampatti Grade 3 or 4, short neck.
6)Patients with compromised Respiratory conditions.
7)Patients with Oropharyngeal or Facial Pathologies
8)Patients who are active smokers. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare Peak Airway Pressure between Volume Control Ventilation and Manual Ventilation during induction of anaesthesia.  0 seconds, 30 seconds, 60 seconds, 90 seconds, 120 seconds, 150 seconds, 180 seconds 
 
Secondary Outcome  
Outcome  TimePoints 
1)To compare End Tidal CO2 between Volume Control Ventilation and Manual Ventilation during induction of anaesthesia.
2)To assess the Incidence of Gastric Insufflation between Volume Control Ventilation and Manual Ventilation during induction of anaesthesia. 
0 seconds, 30 seconds, 60 seconds, 90 seconds, 120 seconds, 150 seconds, 180 seconds 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   Phase 4 
Date of First Enrollment (India)   15/08/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  
Facemask ventilation plays a crucial role in airway management, serving as
a routine procedure to guarantee sufficient oxygenation until the patient’s
airway can be securely established during the induction of anaesthesia.
Facemask ventilation carries potential risks, including inadequate alveolar
ventilation and gastric insufflation. Retention of carbon dioxide due to
inadequate ventilation causes acidosis which may lead to hypoxemia,
atelectasis, and inadequate depth of anaesthesia. Gastric insufflation (GI)
can cause gastric regurgitation, leading to aspiration.
One of the approaches to make mask ventilation safer in an unprotected
airway is to limit Peak Airway Pressure (PAP).
The entry of air into the stomach during positive pressure facemask
ventilation depends on the peak airway pressure, which is determined by a combination of variables related to the patient’s airway, lung condition, and facemask ventilation.
The relationship between PAP and lower oesophageal sphincter muscle tone is an important factor that can influence the entry of air into the stomach during facemask ventilation which might result in regurgitation and
subsequent pulmonary aspiration.
Manual ventilation (MV) is a commonly used facemask ventilation
technique during the induction of anaesthesia. The adjustable pressure
limiting valve (APL) is preferably set at < 20 cm H2O during MV in adults
in order to prevent Gastric Insufflation.

Thus, this study will compare the effects of Volume Control
Ventilation and Manual Ventilation on the airway dynamics such
as Peak Airway Pressure and End Tidal CO2, during induction of
general anaesthesia. In addition, incidence of Gastric Insufflation
between Volume Control Ventilation and Manual Ventilation,
during induction of general anaesthesia will also be studied.
 
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