| CTRI Number |
CTRI/2025/08/093904 [Registered on: 29/08/2025] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| 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 Nasal Mask and Face Mask Ventilation on Air Leak in Obese Adults Undergoing Surgery: A Randomized Controlled Study |
|
Scientific Title of Study
|
Effect of nasal mask versus face mask ventilation on mean air leak in class 2 and class 3 obese adult patients undergoing elective surgery under general anaesthesia: a randomised 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 |
DR RAHUL MAHAJAN |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
AIIMS BATHINDA |
| Address |
Department of Anaesthesia, AIIMS Bathinda, Mandi Dabwali Rd
Department of Anaesthesia, AIIMS Bathinda, Mandi Dabwali Rd
Bathinda
PUNJAB
151001
India |
| Phone |
7305419200 |
| Fax |
|
| Email |
rahulmahajan495@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR NAVNEH SAMAGH |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
AIIMS BATHINDA |
| Address |
Room number 139, IPD building, first floor, A block, Department of Anaesthesia, AIIMS Bathinda, Mandi Dabwali road
Department of Anaesthesia, AIIMS Bathinda, Mandi Dabwali Rd
Bathinda
PUNJAB
151001
India |
| Phone |
8427264480 |
| Fax |
|
| Email |
navnehsamagh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR GOPAL KRISHAN JALWAL |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
AIIMS BATHINDA |
| Address |
Room number 143, IPD building, first floor, A block, Department of Anaesthesia, AIIMS Bathinda, Mandi Dabwali road
Department of Anaesthesia, AIIMS Bathinda, Mandi Dabwali Rd
Bathinda
PUNJAB
151001
India |
| Phone |
7838939833 |
| Fax |
|
| Email |
gopaljalwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Bathinda, Bathinda, Punjab-151001, INDIA |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 RAHUL MAHAJAN |
AIIMS BATHINDA |
Anesthesia department AIIMS Bathinda, Bathinda. Punjab
Bathinda
PUNJAB |
7305419200
rahulmahajan495@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE AIIMS BATHINDA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R635||Abnormal weight gain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
GROUP A-Nasal mask ventilation |
Group A patients will be taken in RAMP position. preoxygenation will be done totally for three minutes by nasal mask and effective mask ventilation will be measured by using mean air leak volume |
| Intervention |
GROUP B- Face Mask ventilation |
Group B patients will be taken in RAMP position. preoxygenation will be done totally for three minutes by face mask and effective mask ventilation will be measured by using mean air leak volume |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients of either gender between age group 18-65 years of class 2 and class 3 obesity undergoing elective surgery under general anaesthesia
ASA-PS III
|
|
| ExclusionCriteria |
| Details |
Patients not willing to give consent
Patients with maxillofacial trauma
Parturients
Edentulous patients |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the mean air leak volume in nasal and face mask ventilation in anaesthetized class 2 and class 3 obese adults undergoing general surgery |
Ten readings will be taken During three minutes of mask ventilation via face mask or nasal mask. The average or mean of ten readings will be taken |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare Mean expired tidal volume in the nasal versus face mask ventilation group
|
For first 10 breaths during mask ventilation via face mask or nasal mask at the end of 3 minutes
|
To compare Mean PIP in the nasal versus face mask ventilation group
|
For first 10 breaths during mask ventilation via face mask or nasal mask at the end of 3 minutes |
To compare Mean Pplat in the nasal versus face mask ventilation group
|
For first 10 breaths during mask ventilation via face mask or nasal mask at the end of 3 minutes |
To compare Mean SpO2 in the nasal versus face mask ventilation group
|
For first 10 breaths during mask ventilation via face mask or nasal mask at the end of 3 minutes |
To compare Mean EtCO2 in the nasal versus face mask ventilation group
|
For first 10 breaths during mask ventilation via face mask or nasal mask at the end of 3 minutes |
To compare Mean leak fraction in the nasal versus face mask ventilation group
|
For first 10 breaths during mask ventilation via face mask or nasal mask at the end of 3 minutes |
| To compare Difference in gastric residual volume in the nasal versus face mask ventilation group |
first reading will be taken pre-operatively, next reading after three minutes of bag & mask ventilation after securing the airway, then the mean difference between these two readings will be calculated at the end of 3 minutes |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 4 |
|
Date of First Enrollment (India)
|
08/09/2025 |
| 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="6"
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
|
Participant Selection After a thorough pre-anaesthetic evaluation and confirmation of eligibility based on inclusion and exclusion criteria, participants will be randomly allocated to one of two groups: - Group A: Nasal mask ventilation
- Group B: Face mask ventilation
Randomization will be performed using a computer-generated list and concealed using sequentially numbered opaque sealed envelopes. Participants will receive detailed study information, and written informed consent will be obtained. Preoperative Preparation - Standard airway assessment including a focused airway examination (line of sight method) will be documented.
- Adjusted body weight (AjBW) will be calculated to guide tidal volume settings.
- Nil per oral (NPO) status will be maintained as per standard guidelines.
- Standard ASA monitoring will be attached upon arrival in the operating room.
- Gastric ultrasound will be performed pre-induction to assess baseline gastric residual volume.
Participants will be positioned using a ramped position (RAMP) to align the external auditory meatus with the sternal notch. Preoxygenation with 100% oxygen at 10 L/min will be performed for 3 minutes. Anaesthesia Induction - Intravenous fentanyl (2 mcg/kg) and propofol (2–2.5 mg/kg) will be administered.
- An appropriately sized nasopharyngeal airway will be inserted post-induction.
- Once mask ventilation is confirmed, muscle relaxant will be administered for neuromuscular blockade.
Ventilation Settings Ventilation will be performed in volume-controlled ventilation (VCV) mode with the following settings: - Fresh gas flow: 10 L/min
- Tidal volume: 7 mL/kg of adjusted body weight
- Respiratory rate: 10 breaths/min
- Pressure limit: 40 cmH2O
Data Collection After 3 minutes of ventilation, the following parameters will be recorded for 10 consecutive breaths, and the mean of the last 5 breaths will be analyzed: - Set tidal volume (mL)
- Expired tidal volume (VtE) (mL)
- Air leak volume (set tidal volume – expired tidal volume) (mL)
- Peak inspiratory pressure (PIP) (cmH2O)
- Plateau pressure (PPLAT) (cmH2O)
- Oxygen saturation (SpO2) (%)
- End-tidal carbon dioxide (EtCO2) (mmHg)
Post-ventilation gastric ultrasound will be performed to assess residual volume. The difference between pre- and post-bag-mask ventilation gastric residual volumes will be recorded. Criteria for Inadequate Ventilation Ventilation will be considered inadequate if any of the following occur: - No visible chest rise
- EtCO2 < 20 mmHg with low amplitude on capnography for three consecutive breaths
In cases of inadequate ventilation, airway adjuncts will be employed, and the patient will be excluded from the analysis. Outcomes and Comparisons The following parameters will be compared between Group A and Group B: - Set tidal volume (mL)
- Expired tidal volume (mL)
- Air leak (mL)
- Leak fraction
- Peak inspiratory pressure (cmH2O)
- End-tidal carbon dioxide (mmHg)
- Oxygen saturation (%)
- Plateau pressure (cmH2O)
- Difference in gastric residual volume before and after bag-mask ventilation (mL)
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