| CTRI Number |
CTRI/2025/09/094491 [Registered on: 10/09/2025] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative evaluation of two supraglottic airway devices (Air Q and Baska Mask) in patients undergoing
ambulatory surgery under general anesthesia. |
|
Scientific Title of Study
|
Comparative evaluation of the Air Q and Baska Mask in patients undergoing ambulatory surgery under general anesthesia. |
| 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 Ranjini M Nair |
| Designation |
PG Resident |
| Affiliation |
Dr Moopens Medical College |
| Address |
Department of Anaesthesiology
7th floor
Dr Moopens Medical College
Naseera nagar
Meppadi
Wayanad
Wayanad
KERALA
673577
India |
| Phone |
9400803150 |
| Fax |
|
| Email |
ranjunair98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhishek R |
| Designation |
Professor |
| Affiliation |
Dr Moopens Medical College |
| Address |
Department of Anaesthesiology
7th floor
Dr Moopens Medical College
Naseera nagar
Meppadi
Wayanad
Wayanad
KERALA
673577
India |
| Phone |
7795098801 |
| Fax |
|
| Email |
abhishek.r@drmoopensmc.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ranjini M Nair |
| Designation |
PG Resident |
| Affiliation |
Dr Moopens Medical College |
| Address |
Department of Anaesthesiology
7th floor
Dr Moopens Medical College
Naseera nagar
Meppadi
Wayanad
Wayanad
KERALA
673577
India |
| Phone |
9400803150 |
| Fax |
|
| Email |
ranjunair98@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Moopens Medical College |
| Address |
Dr Moopens Medical College
Naseera nagar
Meppadi
Wayanad
Pin 673577 |
| Type of Sponsor |
Private medical college |
|
|
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 Ranjini M Nair |
Dr Moopens Medical College |
Department of Anaesthesiology
Dr Moopens Medical College
Naseera nagar
Meppadi
Wayanad
Pin 673577
Wayanad
KERALA |
9400803150
ranjunair98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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 |
Air Q |
The Air-Q is a second-generation supraglottic airway device (SGA) designed for airway management during anesthesia. It features a wide airway tube, self-pressurizing cuff, and a design that facilitates easy blind or fiberoptic-guided endotracheal intubation through the device. It provides effective ventilation and a conduit for intubation, especially in difficult airway situations.
It will used for securing airway on induction and maintained throughout and removed once case is over.primary parameters assessed will include insertion time, ease of insertion, oropharyngeal leak pressure (OLP), ventilation adequacy, and number of insertion attempts. Hemodynamic stability and airway-related complications monitored |
| Comparator Agent |
Baska mask |
The Baska mask is a third-generation supraglottic airway device (SGA) used during general anesthesia for airway management. It features a non-inflatable, self-sealing cuff, integrated gastric drainage, and allows for effective positive pressure ventilation.
It will used for securing airway on induction and maintained throughout and removed once case is over. primary parameters assessed will include insertion time, ease of insertion, oropharyngeal leak pressure (OLP), ventilation adequacy, and number of insertion attempts. Hemodynamic stability and airway-related complications monitored |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients planned for day care surgeries
2. Patients who have been planned for an elective non head and neck surgical intervention by general anaesthesia
3. American Society of Anaesthesiologist Physical Status I-II
|
|
| ExclusionCriteria |
| Details |
ASA III - V patients
Difficult Airway:
a) Mallampati class 3 and 4
b) Adentulous patents
c) Mouth opening less than 5cm
d) Thyromental distance less than 5cm
e) Patients with body mass index morethan or equal to 40.
Patients known to have risk of gastric aspiration, gastro-esophageal refux disease
or hiatus hernia.
Pregnancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Baska Mask’s non-inflatable cuff may offer superior sealing, while the Air-Q with blocker provides easier insertion and dynamic pressure regulation, potentially reducing airway morbidity. |
Airway sealing pressure and Peak airway pressure after placement. Hemodynamic monitoring at insertion and every 5 min for half hour then every 10 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ease of insertion and postoperative complications |
Ease of insertion after placement
postoperative complications after shifting the patient to recovery |
|
|
Target Sample Size
|
Total Sample Size="118"
Sample Size from India="118"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
15/10/2025 |
| 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 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
|
This double-blinded, randomized controlled trial aims to compare the efficacy and safety of two supraglottic airway devices—the Baska Mask and the Air-Q—in adult patients undergoing elective minor or ambulatory surgeries under general anesthesia. A total of 118 patients, aged 18–60 years, classified as ASA physical status I or II with a BMI <40 kg/m², will be recruited and randomly assigned to either device group.
Both devices will be inserted by experienced anesthesiologists without the use of neuromuscular blockers, and the primary parameters assessed will include insertion time, ease of insertion, oropharyngeal leak pressure (OLP), ventilation adequacy, and number of insertion attempts. Hemodynamic stability and airway-related complications, including sore throat, mucosal trauma, and postoperative nausea and vomiting, will also be monitored.
The Air-Q, with its self-pressurizing cuff and gastric protection features, is evaluated as a newer alternative to the Baska Mask, which is known for its self-sealing cuff and integrated suction system. The study’s outcomes aim to provide evidence-based guidance on optimal supraglottic airway device selection in daycare surgical settings, where rapid recovery and minimal complications are critical. |