| CTRI Number |
CTRI/2023/07/055095 [Registered on: 11/07/2023] Trial Registered Prospectively |
| Last Modified On: |
10/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of gastric inflation during mask ventilation at two different tidal volumes for induction of general anaesthesia. |
|
Scientific Title of Study
|
Comparison of ultrasound guided gastric inflation at two different tidal volumes during facemask ventilation for induction of general anaesthesia. |
| 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 Arvind Kumar |
| Designation |
Post Graduate Resident |
| Affiliation |
ABVIMS and Dr RML Hospital |
| Address |
Department of Anaesthesia,
ABVIMS and Dr. RML Hospital,
Presidents Estate
Central Delhi
India
Central
DELHI
110001
India |
| Phone |
8130881845 |
| Fax |
|
| Email |
akarvindkumar914@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neerja Banerjee |
| Designation |
Professor |
| Affiliation |
ABVIMS and Dr RML Hospital |
| Address |
Department of Anaesthesia,
ABVIMS and Dr. RML Hospital,
Presidents Estate
Central Delhi
India
Central
DELHI
110001
India |
| Phone |
9810517575 |
| Fax |
|
| Email |
neerja.banerjee@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arvind Kumar |
| Designation |
Post Graduate Resident |
| Affiliation |
ABVIMS and Dr RML Hospital |
| Address |
Department of Anaesthesia,
ABVIMS and Dr. RML Hospital,
Presidents Estate
Central Delhi
India
Central
DELHI
110001
India |
| Phone |
8130881845 |
| Fax |
|
| Email |
akarvindkumar914@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia,3rd floor PGI Building,ABVIMS and Dr. RML Hospital,Presidents Estate Central Delhi
India |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia |
| Address |
ABVIMS and Dr. RML Hospital,
Presidents Estate
Central Delhi
India |
| Type of Sponsor |
Government 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 |
| Arvind Kumar |
ABVIMS and Dr. RML Hospital |
Department of Anaesthesia,
3rd floor PGI Building
ABVIMS and Dr. RML Hospital,
Presidents Estate
Central Delhi
India
Central
DELHI |
8130881845
akarvindkumar914@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,ABVIMS and Dr RMLHospital |
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 |
TIDAL VOLUME |
Tidal volume of 6ml/kg during facemask ventilation for three minutes |
| Comparator Agent |
TIDAL VOLUME |
Tidal volume of 8ml/kg during facemask ventilation for three minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients posted for elective surgery under general anaesthesia
2. ASA I and II patients
3. Patient aged 18-60 years |
|
| ExclusionCriteria |
| Details |
1. Any anticipated difficult airway including altered anatomy like cervical fractures, maxillofacial abnormalities, restricted neck movement, neck swelling/mass
2. BMI > 30 kg/m2
3. Patients at risk of aspiration
4. Patients with history of respiratory disorders
5. Pregnant patients
6. Patients with history of or posted for gastric surgeries |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ultrasound guided measurement of longitudinal & anteroposterior diameters to calculate cross sectional area(CSA) of gastric antrum |
a.Baseline
b.Three minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Measurement of aretrial carbon dioxide levels (PaCO2) values |
a.Baseline
b.Three minutes |
| Ultrasound guided observation of left paratracheal esophagus for detecting air entry during the three minutes of facemask ventilation. |
Real time |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
20/07/2023 |
| 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="3"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [akarvindkumar914@gmail.com].
- For how long will this data be available start date provided 01-04-2025 and end date provided 31-03-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
We propose to compare tidal volumes of 6ml/kg and 8ml/kg ,by ultrasound guided estimation of gastric inflation i.e. Increase in size of gastric antrum by comparing the cross-sectional area before and after three minutes of facemask ventilation. This will be combined with real-time monitoring of left paratracheal esophageal air entry and evaluation of changes in arterial carbon dioxide values before and after three minutes of facemask ventilation by arterial blood gas analysis. |