| CTRI Number |
CTRI/2025/04/084755 [Registered on: 15/04/2025] Trial Registered Prospectively |
| Last Modified On: |
04/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparison of three techniques of face mask ventilation in patients undergoing surgery. |
|
Scientific Title of Study
|
Comparison of three techniques of two hand face mask ventilation: Prospective randomized
crossover trial in patients undergoing elective surgery. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anjana Wajekar |
| Designation |
Professor, Department of Anaesthesia Critical care and Pain |
| Affiliation |
Tata Memorial Hospital |
| Address |
ACTREC, Tata Memorial Centre, HBNI.
Kharghar, Navi Mumbai.
Mumbai
MAHARASHTRA
410210
India |
| Phone |
9930104106 |
| Fax |
|
| Email |
anjanawajekar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Athul R G |
| Designation |
Junior resident, Department of anaesthesia critical care and pain |
| Affiliation |
Tata Memorial Hospital |
| Address |
Tata memorial hospital, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
7994553050 |
| Fax |
|
| Email |
atulrg995@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Athul R G |
| Designation |
Junior resident, Department of anaesthesia critical care and pain |
| Affiliation |
Tata Memorial Hospital |
| Address |
Tata memorial hospital, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
7994553050 |
| Fax |
|
| Email |
atulrg995@gmail.com |
|
|
Source of Monetary or Material Support
|
| ACTREC, Tata memorial centre. Mumbai |
|
|
Primary Sponsor
|
| Name |
ACTREC, Tata memorial centre |
| Address |
ACTREC, TMC, Kharghar, Navi Mumbai.
410210 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Athul R G |
ACTREC |
ACTREC,Sector 22, unsaved chowk-cis road,
Kharghar,Navi mumbai.
410210
Mumbai
MAHARASHTRA |
9656446880
atulrg995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC- III,ACTREC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Two hand face mask ventilation technique-L technique. |
Transverse mandibular or bilateral
L technique. |
| Intervention |
Two hand face mask ventilation techniques- CE technique, VE technique |
Two techniques of two hand face mask ventilation in all the selected patients ,in randomised order.
1.Bilateral C-E technique.
2.Bilateral thenar eminence grip or the
V-E technique. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA I-III adult patients (18 - 65 years) scheduled to undergo elective surgery under general anaesthesia, with the use of non-depolarising muscle relaxant, will be included. |
|
| ExclusionCriteria |
| Details |
1.Pediatric patients
2.Patients greater than or equal to 66 years of age
3.Patients at risk of aspiration such as pregnant patients, patients with gastro-intestinal obstruction, uncontrolled diabetes mellitus etc
4. Patients undergoing Emergency surgery
5. Patients with anticipated difficult mask ventilation such as patients with a
history of previous surgery, radiation, trauma, burns or mass (benign or malignant) in
the airways or the cranial, cervical and facial regions, patients with restricted neck and
mandible mobility (rheumatoid arthritis, cervical disc disorders, or temporomandibular joint disorders)
6. Patients with beard
7. Edentulous patients
8. Body mass index (BMI) greater than 30 kg/m2 or less than 18.5 kg/m2
9. Patients with history of snoring or obstructive sleep apnoea |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the difference between the set tidal volume (TV) and expired TV on controlled ventilation, of these three types of two hand face mask ventilation. |
Ten consecutive breaths with each technique with a time break of 10 to 20 seconds between each techniques. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the end tidal carbon dioxide (ETCO2) graph as per the Concord
grading scale for facemask ventilation
Number of failed breaths as reflected by expired tidal volumes less than 2 ml/kg as recorded by the anaesthesia machine.
To compare the mean peak inspiratory pressure (PIP) of each technique. |
Ten consecutive breaths with each technique with a time break of 10 to 20 seconds between each techniques. |
|
|
Target Sample Size
|
Total Sample Size="161"
Sample Size from India="161"
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)
|
01/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/05/2025 |
| 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 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
|
Comparison of three techniques of two hand face mask ventilation:Prospective randomized crossover trial in patients undergoing elective surgery. Written informed consent for participation in this study will be obtained one day prior to surgery from all ASA 1-3 adults patients (18-65 years, with no anticipated difficult airway) scheduled to undergo elective surgery under general anaesthesia, with the use of non- depolarising muscle relaxant, during the two year study duration, in our institute. All the patients will be explained the sequence of events that will be occurring during induction of anaesthesia. A detailed discussion about face mask ventilation, airway management before surgery, anaesthesia protocol and its inherent risks ,benefits and safety measures will be done with them. Their demographic details including age ,sex, weight, any comorbidities along with their treatment, etc will be noted. initial hemodynamic parameters like HR, BP, SPO2 and ECG rhythm will be noted. After adequate preoxygenation, anaesthesia inducing agents and non-depolarising muscle relaxant will be given(confirmed with TOF). Three types of two hand face mask ventilation will be tried under volume control mode of ventilation with fixed respiratory parameters, and corresponding Expiratory tidal volume, EtCO2 and Peak inspiratory pressure are noted from ventilator machine. The patient will be monitored with HR, BP, SPO2, and ECG throughout the procedure. |