| CTRI Number |
CTRI/2025/11/097382 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
01/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
Compare Ease of Ventilation Using a Facemask Before and After Giving Muscle Relaxant Medication |
|
Scientific Title of Study
|
Comparative Analysis of Facemask Ventilation Effectiveness Pre and Post Neuromuscular Blocking Drug Administration: A Prospective Observational 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 |
MEDHA DINESH RAI |
| Designation |
M Sc Anaesthesia and Operation Theatre Technology |
| Affiliation |
K S Hegde Medical Academy |
| Address |
5th floor Department of Anaesthesia and Operation Theatre Technology K S Hegde Medical Academy Nithyananda Nagar Deralakatte Mangaluru
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
8296495041 |
| Fax |
|
| Email |
medhashetty1@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
SHARADA ADIGA M |
| Designation |
Senior resident Department of Anaesthesiology and Critical Care |
| Affiliation |
Justice K S Hegde Charitable Hospital |
| Address |
Department of Anaesthesiology and Critical Care Justice K S Hegde Charitable Hospital
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
9740442123 |
| Fax |
|
| Email |
Sharada.3149@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
SHARADA ADIGA M |
| Designation |
Senior resident Department of Anaesthesiology and Critical Care |
| Affiliation |
Justice K S Hegde Charitable Hospital |
| Address |
Department of Anaesthesiology and Critical Care Justice K S Hegde Charitable Hospital
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
9740442123 |
| Fax |
|
| Email |
Sharada.3149@gmail.com |
|
|
Source of Monetary or Material Support
|
| Justice K S Hegde Charitable Hospital
Deralakatte
Mangalore 575018
Karnataka India |
|
|
Primary Sponsor
|
| Name |
MEDHA DINESH RAI |
| Address |
Department of Anaesthesia and Operation Theatre Technology
K S Hegde Medical Academy Nithyananda Nagar Deralakatte
Mangaluru 575018 Karnataka India |
| 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 |
| Sharada Adiga M |
Justice K S Hegde Charitable Hospital |
Department of Anaesthesiology and Critical Care medicine K S Hegde Medical Academy Nithyananda Nagar Deralakatte Mangaluru Dakshina Kannada KARNATAKA |
9740442123
Sharada.3149@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| K S HEGDE MEDICAL ACADEMY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K829||Disease of gallbladder, unspecified, (2) ICD-10 Condition: N645||Other signs and symptoms in breast, (3) ICD-10 Condition: H738||Other specified disorders of tympanic membrane, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing general anaesthesia
Adult patients of age greater than or equal to 18 years and less than or equal to 65 years
Patients with American Society of Anesthesiologists grade I and II
BMI between 18 to 30
Patients receiving vecuronium |
|
| ExclusionCriteria |
| Details |
Planned awake tracheal intubation
Full stomach
A known allergy to the medications being studied
Pregnancy
Neuromuscular disorder
Rapid sequence intubation
Facial deformity
Anticipated difficult mask ventilation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the efficacy of Facemask ventilation before and after Neuromuscular blocking drug administration in terms of peak
airway pressure, expired tidal volume, minute ventilation, ETCO2 and SpO2. |
4 minutes in intraoperative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the ease of Face mask ventilation and
Comfort of anaesthesiologist. |
4 minutes in intraoperative |
|
|
Target Sample Size
|
Total Sample Size="132" Sample Size from India="132"
Final Enrollment numbers achieved (Total)= "132"
Final Enrollment numbers achieved (India)="132" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/11/2025 |
| Date of Study Completion (India) |
30/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The most fundamental and important skill in airway management is facemask ventilation, which is the primary line of treatment in patients who are apnoeic. It is an essential element of airway management skills crucial for both general anaesthesia and rescue oxygenation. During general anaesthesia, it is vital for ensuring adequate oxygenation and ventilation of the patient after the administration of anaesthetic / muscle relaxant agents. This technique involves placing a mask over the patient’s nose and mouth and applying positive pressure to facilitate the flow of oxygen or anaesthetic gases into the lungs. In emergency situations, facemask ventilation becomes an indispensable tool for providing immediate oxygenation to the patients who are unable to breathe independently. Mastery of this skill is essential for preventing complications such as hypoxia and ensuring effective airway management in a variety of clinical scenarios. The routine use of neuromuscular blocking drugs (NMBDs) before testing mask ventilation is a subject of debate. While NMBDs generally assist with intubation and may improve facemask ventilation, they can also obstruct ventilation by causing upper airway collapse. Advocates for "testing" the ability to ventilate before administering NMBDs argue that the risk of complete airway obstruction due to NMBD induced collapse could lead to a “cannot intubate, cannot ventilate” scenario if intubation attempts fail. On the other hand, some suggest that residual muscle tone after anaesthesia induction might create resistance during mask ventilation, which could be misinterpreted as difficult mask ventilation. DMV arises as a result of several technique-related and / or airway-related issues. . There is some evidence for administering an NMBD immediately after induction to facilitate ventilation, enabling early identification of patients at risk of difficult ventilation, facilitating prompt airway management, potentially reducing the risks associated with hypoxia. Therefore, the current study is envisaged to assess how neuromuscular blocking medication affects facemask ventilation in individuals undergoing general anaesthesia. |