| CTRI Number |
CTRI/2025/04/084265 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
04/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [METHODS OF MASK HOLDING] |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparison of two methods of mask holding in patients undergoing general anesthesia |
|
Scientific Title of Study
|
Comparison of two-handed C-E technique and V-E technique for mask
ventilation in unconscious apnoeic adults with simulated C-spine immobilization: A
randomized crossover 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 SUSHMA H |
| Designation |
Senior Resident |
| Affiliation |
KASTURBA MEDICAL COLLEGE,MANIPAL |
| Address |
Department of Anesthesiology, Main OT Complex, Baliga block
Kasturba Medical College and Hospital, Manipal 576104
Udupi
KARNATAKA
576104
India |
| Phone |
09483305224 |
| Fax |
|
| Email |
sushmahaithal237@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SUSHMA H |
| Designation |
SENIOR RESIDENT |
| Affiliation |
KASTURBA MEDICAL COLLEGE,MANIPAL |
| Address |
Department of Anesthesiology, KASTURBA MEDICAL COLLEGE AND HOSPITAL, MANIPAL 576104
Udupi
KARNATAKA
576104
India |
| Phone |
09483305224 |
| Fax |
|
| Email |
sushmahaithal237@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SUSHMA H |
| Designation |
Senior Resident |
| Affiliation |
KASTURBA MEDICAL COLLEGE,MANIPAL |
| Address |
Department of Anesthesiology, Main OT Complex, Baliga block
Kasturba Medical College and Hospital, Manipal 576104
Udupi
KARNATAKA
576104
India |
| Phone |
09483305224 |
| Fax |
|
| Email |
sushmahaithal237@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College and Hospital, Udupi-Hebri road, Madhav nagar, Manipal, Udupi district, Karnataka state, India 576104 |
|
|
Primary Sponsor
|
| Name |
DR SUSHMA H |
| Address |
Department of Anesthesiology, Main OT Complex, Baliga block, Kasturba Medical College and Hospital, Manipal, Udupi district, Karnataka state, India 576104 |
| Type of Sponsor |
Other [Self] |
|
|
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 Sushma H |
DEPARTMENT OF ANAESTHESIOLOGY KASTURBA MEDICAL COLLEGE,MANIPAL |
KASTURBA MEDICAL COLLEGE AND HOSPITAL, MANIPAL 576104
Udupi
KARNATAKA |
9483305224
sushmahaithal237@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KASTURBA MEDICAL COLLEGE AND KASTURBA HOSPITAL 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 |
| Intervention |
TECHNIQUE OF MASK HOLDING |
Two handed C-E technique of mask ventilation is done for 2 min while induction of general anesthesia |
| Comparator Agent |
TECHNIQUE OF MASK HOLDING |
Two handed V-E technique of mask ventilation is done for 2 min during induction of general anesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients posted for surgery under general anesthesia
2. American Society of Anesthesiologists -physical status (ASA-PS) grade 1 to 3 patients
|
|
| ExclusionCriteria |
| Details |
1.Patients with anticipated difficult airway
2.Pregnant patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean expired tidal volume as measured by the anesthetic machine flow sensor |
Mean expired tidal volume as measured by the anesthetic machine flow sensor over 1 min of mask ventilation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean expired tidal volume per predicted body weight and incidence of audible leak |
Over 2 min of mask ventilation |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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)
|
21/04/2025 |
| 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 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
|
This study is done to compare the efficacy of two techniques of mask ventilation (two-handed C-E technique and two-handed V-E technique) in unconscious apneic adults with simulated C spine immobilization. Objective is to compare of average expired tidal volume achieved using two-handed C-E technique and V-E technique in unconscious apneic adults with simulated C spine immobilization. Patients with C-spine injury are an important subset of patients who require special care during mask ventilation. Airway management in patients with neck injury requires C-spine immobilization as inordinate flexion or extension of the neck can lead to spinal cord injury and quadriparesis. Mask ventilation has been described as the intervention that leads to maximum neck mobility and hence strict C-spine immobilization is paramount during mask ventilation. In this sub-population, the performance of the two techniques has not been compared. Hence this study will help in comparing the technique of mask ventilation. |