| CTRI Number |
CTRI/2024/11/076867 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
16/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Effect of head rotation on the of
mask ventilation |
|
Scientific Title of Study
|
Effect of left head rotation versus right head rotation on the efficacy of
mask ventilation in apneic adult patients undergoing surgery under general
anaesthesia : a prospective randomised 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. Harshit Sharma |
| Designation |
Junior Resident |
| Affiliation |
AIIMS BATHINDA |
| Address |
Department Of Anaesthesiology, 1st Floor, OT complex, Hospital building, AIIMS BATHINDA, Mandi Dabwali Road, Bathinda
Punjab
Bathinda
PUNJAB
151001
India |
| Phone |
|
| Fax |
|
| Email |
hshanu1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Anju Grewal |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
AIIMS BATHINDA |
| Address |
Department Of Anaesthesiology, Room No. 141, 1st Floor, OT complex, Hospital building, AIIMS BATHINDA, Mandi Dabwali Road, Bathinda
Punjab
Bathinda
PUNJAB
151001
India |
| Phone |
9815482626 |
| Fax |
|
| Email |
dranjugrewal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Anju Grewal |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
AIIMS BATHINDA |
| Address |
Department Of Anaesthesiology, Room No. 141, 1st Floor, OT complex, Hospital building, AIIMS BATHINDA, Mandi Dabwali Road, Bathinda
Punjab
PUNJAB
151001
India |
| Phone |
9815482626 |
| Fax |
|
| Email |
dranjugrewal@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Bathinda Mandi Dabwali Rd, Bathinda, Punjab India - 151001 |
|
|
Primary Sponsor
|
| Name |
Dr Harshit Sharma |
| Address |
Department Of Anaesthesiology, 1st Floor, Hospital building, AIIMS BATHINDA, Mandi Dabwali Road, Bathinda
Punjab |
| 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 Harshit Sharma |
AIIMS BATHINDA |
OT complex, 1st floor, Department of Anaesthesiology, AIIMS BATHINDA, Mandi Dabwali Road, Bathinda
Punjab, India -151001
Bathinda
PUNJAB |
9811470501
hshanu1998@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 |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HEAD ROTATION SEQUENCE IN MASK VENTILATION IN GROUP A |
Face mask ventilation in each head position will be done for 60 seconds (i.e., 12 breaths per position)
using two hand EC technique in which the thumb and index finger of both hands form a C shape to
compress the mask while the third, fourth, and fifth fingers of each hand lifts the lower jaw forming
a ‘E’ shape
GROUP A : Left-neutral-right |
| Comparator Agent |
HEAD ROTATION SEQUENCE IN MASK VENTILATION IN GROUP B |
In comparison to Group A here, the sequence of head rotation will be different: Right-Neutral-left, as this is a crossover study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
-Adult patients of either gender between 18 and 65 years of age scheduled for elective surgery
under general anaesthesia
• American Society of Anaesthesiologists (ASA) physical status I, II, III
• Body Mass Index between 18.5 to 30 kg/m2
• Neck circumferences less than 40 cm for females and less than 42 cm for males |
|
| ExclusionCriteria |
| Details |
-Refusal of consent
• Pre-existing Respiratory conditions such as COPD or Restrictive Lung disease
• limited head rotation (less than 80 degrees in both directions) and limited neck movements
(less than 50 degrees flexion and 80 degrees extension)
• Maxillofacial trauma
• Edentulous patients
• cervical spine pathology
• Pregnant patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. leak fraction
2.peak inspiratory pressure |
average of 12 breaths in each head position |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
operator ease of mask ventilation in different head positions using 5 point likert
scale |
at end of ventilation in each head position |
|
|
Target Sample Size
|
Total Sample Size="495"
Sample Size from India="495"
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)
|
27/11/2024 |
| 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) |
Open to Recruitment |
|
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-identification.
- 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 whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [hshanu1998@gmail.com].
- For how long will this data be available start date provided 21-11-2024 and end date provided 21-05-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This thesis protocol titled “Effect of Left Head Rotation Versus Right Head Rotation on the Efficacy of Mask Ventilation in Apneic Adult Patients Undergoing Surgery Under General Anaesthesia: A Prospective Randomised Crossover Study†by Dr. Harshit Sharma aims to evaluate the impact of different head positions (left vs. right) on the effectiveness of mask ventilation. This prospective, randomized crossover study is designed to measure parameters such as leak fraction, peak inspiratory pressure, and operator ease during mask ventilation with different head rotations. The study will be conducted at AIIMS Bathinda, including adult patients undergoing general anaesthesia, to determine if left or right head rotation can improve mask ventilation, which is crucial in maintaining a clear airway. This research is particularly relevant due to limited literature on the comparative benefits of head positioning in airway management during anaesthesia. The protocol also outlines rigorous monitoring, consent processes, and ethical considerations for participant safety. |