| CTRI Number |
CTRI/2025/07/092088 [Registered on: 31/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two hand chin lift vs Hybrid mask technique for breathing support by new learner’s in adults under anaesthesia |
|
Scientific Title of Study
|
Comparison of two hand C-E with hybrid mask ventilation techniques by novice airway providers in adult patients under general anaesthesia |
| 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 Payal Pandya |
| Designation |
Doctor (Resident) |
| Affiliation |
ABVIMS and Dr RML hospital New Delhi |
| Address |
Department of anaesthesia ABVIMS and Dr RML hospital New Delhi
New Delhi DELHI 110001 India |
| Phone |
8839633180 |
| Fax |
|
| Email |
Pandyapayal12@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sangeeta Yadav |
| Designation |
Associate professor |
| Affiliation |
ABVIMS and Dr RML hospital |
| Address |
Department of anaesthesia ABVIMS and Dr RML hospital New Delhi
New Delhi DELHI 110001 India |
| Phone |
9871386600 |
| Fax |
|
| Email |
Sangiydv80@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sujali nang chupoo |
| Designation |
Associate professor |
| Affiliation |
ABVIMS and Dr RML hospital |
| Address |
Department of anaesthesia ABVIMS and Dr RML hospital New Delhi
New Delhi DELHI 110001 India |
| Phone |
8587887234 |
| Fax |
|
| Email |
Sujalichoupoo@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia , ABVIMS and Dr RML hospital , baba kharak singh marg, New Delhi, Delhi, India, pin 110001 |
|
|
Primary Sponsor
|
| Name |
ABVIMS and Dr RML Hospital |
| Address |
Room no 301, Department of anaesthesia, Third floor, ABVIMS and Dr RML hospital, New Delhi, Delhi, India, 110001 |
| 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 Payal Pandya |
ABVIMS and Dr RML hospital |
Room no 301 department of anaesthesia third floor ABVIMS and Dr RML hospital New Delhi pin 110001 India New Delhi DELHI |
8839633180
Pandyapayal12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, ABVIMS and Dr RML hospital |
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 |
Hybrid mask ventilation technique |
Two hand Hybrid mask ventilation technique performed by novice airway providers under general anaesthesia in adult patients |
| Comparator Agent |
Standard two hand C-E technique |
Traditional C-E hand position for mask ventilation technique using two hands by novice airway providers in adult patients under general anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA class I and II
Patients posted for elective surgery under general anaesthesia
Modified Mallampti grade I and II |
|
| ExclusionCriteria |
| Details |
Patients which predictors of difficult mask ventilation that is edentulous, beard, history of snoring, old age, BMI greater than 30 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 2 minutes or 24 breaths mean exahaled tidal volume in both groups |
2 minutes or 24 breaths mean exahaled tidal volume in both groups |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of failed breaths reflected by no exhaled tidal volume & operator comfort based on 5 point likert scale |
Total no of failed breaths at one minute two minutes & three minutes from baseline |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/08/2025 |
| 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="5" 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
|
The study will be conducted following approval from the Institutional Ethical and Scientific Review Committee. All enrolled patients will undergo a routine pre-anesthetic checkup, including medical history, physical examination, and airway assessment. Adequate fasting status will be ensured, and informed written consent will be obtained in a language understood by the patient.Participants will be randomly assigned to one of two groups (Group A or B) using computer-generated randomization, with group assignments concealed in sequentially numbered opaque envelopes.Upon arrival in the operating room, standard monitoring (pulse oximetry, 5-lead ECG, and non-invasive blood pressure) will be initiated, and baseline parameters including heart rate, systolic and diastolic blood pressure, and oxygen saturation will be recorded.An intravenous line will be secured, and premedication with IV midazolam (0.05 mg/kg) will be administered. Each patient will receive pre-oxygenation with 100 percent oxygen at 10 L/min for 3 minutes using a well-fitting transparent face mask.General anesthesia will be induced using IV propofol (2 mg/kg), IV fentanyl (2 mcg/kg), and IV vecuronium (0.1 mg/kg). Mechanical ventilation will be set in pressure-controlled mode (peak pressure 15 cm H2O, no PEEP, 12 breaths per minute, I:E ratio 1:2).A consultant anesthesiologist will perform mask ventilation for the first minute to confirm adequacy, then hand over to a novice airway provider (less than 3 years of experience) for 2 minutes of ventilation using the allocated technique—either two-hand C-E or hybrid (dominant hand C-E and non-dominant hand thenar eminence). An independent observer will record parameters such as exhaled tidal volume and oxygen saturation.If oxygen saturation drops below 94 percent or there is any hemodynamic instability, the consultant anesthesiologist will intervene immediately to ensure patient safety. After the study period, the anesthesiologist will proceed with standard care.Study Aim is to compare the effectiveness of the two-hand C-E technique and the hybrid mask ventilation technique when performed by novice airway providers in adult patients under general anesthesia.
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