| CTRI Number |
CTRI/2026/02/103345 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
05/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two mask holding ventilation techniques in cervical spine surgeries |
|
Scientific Title of Study
|
Effectiveness of C-E vs modified V-E two handed mask ventilation technique in patients with cervical spine injury requiring surgical fixation- A prospective randomized controlled 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 |
Akrity Singh |
| Designation |
Associate professor |
| Affiliation |
Indira Gandhi Institute Of medical Sciences |
| Address |
Department of Anaesthesiology and critical care medicine, First floor, Ward block, Indira Gandhi institute of medical sciences, Patna
Patna
BIHAR
800014
India |
| Phone |
9693876659 |
| Fax |
|
| Email |
drakrity_s@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Akrity Singh |
| Designation |
Associate professor |
| Affiliation |
Indira Gandhi Institute Of medical Sciences |
| Address |
Department of Anaesthesiology and critical care medicine, First floor, Ward block, Indira Gandhi institute of medical sciences, Patna
BIHAR
800014
India |
| Phone |
9693876659 |
| Fax |
|
| Email |
drakrity_s@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Akrity Singh |
| Designation |
Associate professor |
| Affiliation |
Indira Gandhi Institute Of medical Sciences |
| Address |
Department of Anaesthesiology and critical care medicine, First floor, Ward block, Indira Gandhi institute of medical sciences, Patna
BIHAR
800014
India |
| Phone |
9693876659 |
| Fax |
|
| Email |
drakrity_s@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Indira Gandhi Institute of Medical sciences |
| Address |
Sheikhpura, Raja bazar, Patna-800014 |
| 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 Akrity Singh |
Indira gandhi institute of medical sciences |
Department of Anaesthesiology and critical care medicine, Ward Block first floor
Patna
BIHAR |
9693876659
drakrity_s@yahoo.co.in |
|
|
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: S129||Fracture of neck, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Two handed mask ventilation technique C-E vs V-E was compared in cervical surgery patients for effectiveness for 3 minutes. |
Ventilating the patients with thumb and index finger making C shape and rest three fingers making E on mandible vs two thumbs making V and rest fingers on mandible as E for mask ventilation before anaesthesia and analysing effectiveness |
| Intervention |
C-E vs V-E Two handed mask ventilation technique was compared in cervical surgery patients |
Ventilating the patients with thumb and index finger making C shape and rest three fingers making E on mandible vs two thumbs making V and rest fingers on mandible as E for mask ventilation before anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients of ASA grade 1,II
Patients posted for cervical spine fixation surgeries |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary objective of the study is to determine the difference in mean tidal volume between the two groups (C-E vs. V-E) after induction of general anaesthesia. |
10 breaths for both C-E and V-E techniques. The mean of last five breaths will be used for the final analysis to calculate expiratory tidal volume and airway pressure . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary objectives included the difference in peak airway pressure (Paw), to determine the failure rates of mask ventilation and the difference in the percentage of cases requiring oropharyngeal airway due to failure of ventilation between the two groups |
differences in airway pressure,ventilation failure rates during initial 5 minutes of mask ventilation |
|
|
Target Sample Size
|
Total Sample Size="124"
Sample Size from India="124"
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)
|
16/03/2026 |
| 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="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Patients
with cervical spine injury comes with cervical collar in place and main concern
is to protect the spine by manual in line stabilisation during intubation and
mask ventilation without neck extension. The primary aim of this study is to
determine and compare the efficiency of mask ventilation in adult subjects by using either the C-E
technique or the modified V-E technique with jaw thrust ,scheduled for cervical
spine surgeries. |