| 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
|
|
|
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
|
|
|
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. |