| CTRI Number |
CTRI/2024/10/075242 [Registered on: 14/10/2024] Trial Registered Prospectively |
| Last Modified On: |
05/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessing ventilation with bag and mask before and after giving muscle relaxant. |
|
Scientific Title of Study
|
Comparison of face mask ventilation before and after the administration of neuromuscular blocking drugs |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Smriti Agrawal |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College , Manipal |
| Address |
Department of Anaesthesiology, Kasturba Medical College, Manipal
Udupi
KARNATAKA
576014
India |
| Phone |
9643445589 |
| Fax |
|
| Email |
smritiagrawal95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun Kumar HD |
| Designation |
Associate professor |
| Affiliation |
Kasturba Medical College , Manipal |
| Address |
Department of Anaesthesiology, Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9008415858 |
| Fax |
|
| Email |
arunhd2000@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arun Kumar HD |
| Designation |
Associate professor |
| Affiliation |
Kasturba Medical College , Manipal |
| Address |
Department of Anaesthesiology, Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9008415858 |
| Fax |
|
| Email |
arunhd2000@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Kasturba Medical College, Manipal, Udupi district, Karnataka, India. Pin code 576104 |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College Manipal |
| Address |
Department of Anaesthesiology, Kasturba Medical College, Manipal, Udupi district, Karnataka, India. Pin code 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 Smriti Agrawal |
Kasturba Medical College, Manipal |
Department of Anaesthesiology, Kasturba Medical College, Manipal, Udupi district, Karnataka, India. Pin code 576104
Udupi
KARNATAKA |
9643445589
smritiagrawal95@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 |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective surgery under general anaesthesia where placement of
endotracheal tube is considered.
American society of Anesthesiologists classification I, II, III patients |
|
| ExclusionCriteria |
| Details |
Patients with known allergy to muscle relaxant
Patients with any contraindications to muscle relaxant.
Pregnant patients.
Patients with full stomach.
Patients with hiatus hernia.
Emergency surgery. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the ease of face mask ventilation before and after the administration of
neuromuscular blocking drugs in terms of
Expired tidal volume.
Peak inspiratory pressure.
Minute ventilation. |
T1: After loss of verbal contact post administration of propofol as per standard of care.
T2: 3 minutes after administration of neuromuscular blocking agent Vecuronium as per standard of acre. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the factors affecting face mask ventilation including Mallampatti grade.
BMI more than 30kg/m2.
Beard (Absence/presence).
Ability to & extent of mandibular protrusion.
Lack of dentition.
Limited cervical spine motion.
|
T1: After loss of verbal contact post administration of propofol as per standard of care.
T2: 3 minutes after administration of neuromuscular blocking agent Vecuronium as per standard of acre. |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
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)
|
16/10/2024 |
| 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="2"
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
|
Face mask ventilation is considered the most basic technique
for maintaining patency of airway in unconscious and apneic patients. It is the
rescue method of ventilation in difficult intubation.
In routine practice of general anaesthesia, we
test the ability to ventilate the patient (check ventilation) before giving
neuromuscular blocking drugs for tracheal intubation to avoid cannot intubate-
cannot ventilate scenario. The administration of neuromuscular blocking agent Vecuronium could result in increased ease of face mask ventilation. |