| CTRI Number |
CTRI/2019/11/021848 [Registered on: 04/11/2019] Trial Registered Prospectively |
| Last Modified On: |
26/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparative study of breathing through new intraoral (fits inside mouth) mask versus that by using the usual face mask during starting of general anaesthesia |
|
Scientific Title of Study
|
Comparative evaluation of ventilation using intraoral mask and conventional face mask |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KESHAV GAUR |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
3rd FLOOR, BL TANEJA BLOCK, DEPARTMENT OF ANAESTHESIOLOGY, MAULANA AZAD MEDICAL COLLEGE AND LOK NAYAK HOSPITAL
North West
DELHI
110002
India |
| Phone |
08826228805 |
| Fax |
|
| Email |
keshavgaur14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr UC VERMA |
| Designation |
DIRECTOR PROFESSOR |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND INTENSIVE CARE, B.L. TANEJA BLOCK, LOK NAYAK HOSPITAL, DELHI 110002
Central
DELHI
110002
India |
| Phone |
9868604211 |
| Fax |
|
| Email |
ucverma2k@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr UC VERMA |
| Designation |
DIRECTOR PROFESSOR |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND INTENSIVE CARE, B.L. TANEJA BLOCK, LOK NAYAK HOSPITAL, DELHI 110002
DELHI
110002
India |
| Phone |
9868604211 |
| Fax |
|
| Email |
ucverma2k@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and associated Hospitals |
|
|
Primary Sponsor
|
| Name |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
MAULANA AZAD MEDICAL COLLEGE, BAHADUR SHAH ZAFAR MARG, DELHI 110002 |
| 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 |
| DR UC VERMA |
LOK NAYAK HOSPITAL |
3rd FLOOR, BL TANEJA BLOCK,DEPARTMENT OF ANAESTHESIOLOGY, MAULANA AZAD MEDICAL COLLEGE, DELHI 110002
Central
DELHI |
9968604211
ucverma2k@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
POSTED FOR ELECTIVE SURGERY UNDER GENERAL ANAESTHESIA |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional face mask |
conventional silicon face mask of appropriate size
Applied over the face , only once , for two minutes |
| Intervention |
NUMASK |
INTRAORAL MASK
Applied orally (between lips and gums) , only once , for a duration of two minites |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I,II,III |
|
| ExclusionCriteria |
| Details |
1. ANTICIPATED DIFFICULT INTUBATION
2. ANTICIPATED DIFFICULT MASK VENTILATION AS INDICATED BY BEARDED PATIENTS, EDENTULOUS, MORBID OBESITY, HISTORY OF SNORING, OBESITY
3. PATIENTS WITH HIGH ASPIRATION RISK (GERD, PREGNANCY) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| DIFFERENCE IN EXPIRED MINUTE VOLUME DELIVERED BY TWO TYPE OF MASKS |
AT THE TIME OF EXPIRATION OF EACH BREATH |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. ETCO2
2. ANY SIGN OF TRAUMA TO LIPS, GUMS OR TEETH |
3-4 MINUTES |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/11/2019 |
| Date of Study Completion (India) |
12/12/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NOT YET |
|
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 [keshavgaur14@gmail.com].
- For how long will this data be available start date provided 16-10-2021 and end date provided 16-10-2031?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
BAG MASK VENTILATION IS THE CORNER STONE OF AIRWAY MANAGEMENT. IT PERMITS OXYGENATION AND VENTILATION UNTIL A MORE DEFINITIVE AIRWAY CAN BE ESTABLISHED.BAG MASK VENTILATION CONVENTIONALLY REQUIRES FORMATION OF AN EFFECTIVE SEAL AND AIRWAY PATENCY. ASA I,II AND III PATIENTS OF AGE 18-60 YEARS OF EITHER SEX WHO ARE POSTED FOR SURGERY REQUIRING GENERAL ANAESTHESIA ARE SELECTED. PRE OXYGENATED FOR 3 MINUTES AND THEN INDUCED USING A STANDARD ANAESTHESIA TECHNIQUE WITH PROPOFOL, FENTANYL AND VECURONIUM. THE PATIENT IS VENTILATED USING EITHER THE INTRAORAL MASK OR THE CONVENTIONAL FACE MASK AND TIDAL VOLUME EXPIRED AS WELL AS ETCO2 ARE NOTED AFTER 1 MINUTE STABILIZATION PERIODS FOR EACH MASK
|