| CTRI Number |
CTRI/2025/06/089896 [Registered on: 30/06/2025] Trial Registered Prospectively |
| Last Modified On: |
15/06/2025 |
| 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
|
Comparison of BASKA Mask and Igel Supraglottic Airway devices in Patients undergoing Planned Surgery |
|
Scientific Title of Study
|
Comparison of BASKA Mask and Igel Supraglottic Airway devices in Patients undergoing Elective Surgery - Randomized Control Trail |
| 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 Srinivasan S K |
| Designation |
Professor |
| Affiliation |
Vinayaka Missions Medical College and Hospital, Karaikal |
| Address |
Department of Anaesthesiology Vinayaka Mission Medical College and hospital Keezhakasakudy Medu Kottucherry Post Puducherry Karaikal
PONDICHERRY 609609
India
Karaikal PONDICHERRY 609609 India |
| Phone |
9360363321 |
| Fax |
|
| Email |
drsrisha@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Pallaki Sai Mishita Reddy |
| Designation |
Junior Resident/Post Graduate |
| Affiliation |
Vinayaka Missions Medical College and Hospital, Karaikal |
| Address |
Room No 2 Department of Anaesthesiology Vinayaka Mission Medical College and hospital Keezhakasakudy Medu Kottucherry Post Puducherry Karaikal
PONDICHERRY 609609
India
Karaikal PONDICHERRY 609609 India |
| Phone |
9108102566 |
| Fax |
|
| Email |
mishitapallaki42@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Pallaki Sai Mishita Reddy |
| Designation |
Junior Resident/Post Graduate |
| Affiliation |
Vinayaka Missions Medical College and Hospital, Karaikal |
| Address |
Room No 2 Department of Anaesthesiology Vinayaka Mission Medical College and hospital Keezhakasakudy Medu Kottucherry Post Puducherry Karaikal
PONDICHERRY 609609
India
Karaikal PONDICHERRY 609609 India |
| Phone |
9108102566 |
| Fax |
|
| Email |
mishitapallaki42@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Medical College and Hospital, Keezhakasudimedu,Karaikal, Pondicherry,India-609609 |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Medical College and Hospital |
| Address |
Vinayaka Missions Medical College and Hospital Keezhakasakudy Medu Kottucherry post Puducherry 609609 |
| 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 Pallaki Sai Mishita Reddy |
Vinayaka Missions Medical College and Hospital |
Room No.2, Department of Anaesthesiology Karaikal PONDICHERRY |
9108102566
mishitapallaki42@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical 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 |
BASKA MASK |
Participants will undergo insertion of BASKA Mask during elective procedures. |
| Intervention |
I-GEL |
Participants will undergo insertion of I-GEL during elective procedures. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
- ASA Class I,II and III
- BMI less than 35kg/m2
- Surgery for less than 1 hour
- Patients who provide informed consent for participation in the study
|
|
| ExclusionCriteria |
| Details |
- Pregnancy
- Undergoing head and neck surgeries
- Previous history of difficult intubation
- Risk of gastric aspiration
- Mouth opening less than 3 cm.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) To assess and compare the overall success rate of airway management, including successful insertion and ventilation efficacy by using the Baska mask and I-gel in patients undergoing elective surgery.
2) To compare the ease of use and handling by healthcare providers for the Baska mask and I-gel. |
until end of procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the incidence of complications (e.g., airway leaks, desaturation events) associated with the use of the Baska mask and I-gel.
2. To investigate the impact of patient characteristics (e.g., age, BMI) on the performance of the Baska mask and I-gel in elective surgery scenarios. |
until end of procedure |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/06/2025 |
| 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
|
- INTRODUCTION:
Surgical
procedures under general anaesthesia require a patent airway for safe and
smooth conduction of anaesthesia . For such procedures, various supraglottic
airway devices have been designed and are being used exceedingly. Although
endotracheal intubation is the gold standard for airway management, it is being
replaced by supraglottic airway devices because they are easy to introduce,
better tolerated and results in a lesser haemodynamic response. Further these
devices have lesser implications on airway and respiratory mechanics.
2. RESEARCH QUESTION: IS BASKA MASK BETTER
THAN I GEL IN ELECTIVE SURGERIES ?
3.AIM AND OBJECTIVES:
Aim:
Compare the effectiveness of I-gel and Baska mask in terms of Ease of
Insertion and its success rate, sealing pressure, Quality of ventilation and
incidence of post insertion complications.
Primary
Objective:
1)
To assess
and compare the overall success rate of airway management, including successful
insertion and ventilation efficacy by using the Baska mask and I-gel in
patients undergoing elective surgery.
2) To compare the ease of use and handling by
healthcare providers for the Baska mask and I-gel.
Secondary
Objectives:
1. To evaluate
the incidence of complications (e.g., airway leaks, desaturation events)
associated with the use of the Baska mask and I-gel.
2. To investigate
the impact of patient characteristics (e.g., age, BMI) on the performance of
the Baska mask and I-gel in elective surgery scenarios.
5.REVIEW OF LITERATURE:
1) According to a study by
Sinasamy et Al, Group IG showed a significantly shorter median insertion time
(13.3 [interquartile range, IQR 7.8] vs. 17.0 [IQR 9.6] s; P < 0.001), a
higher percentage in the ’very easy’ ease of insertion category (62.5% vs. 10.0%;
P < 0.001), a higher percentage in the no corrective manoeuvre category
(92.5% vs. 72.5%; P = 0.003) and a higher percentage in the no post-operative
throat pain category (67.5% vs. 32.5%; P = 0.011) than Group BM. However, Group
BM showed a significantly higher generated PAP than Group IG (12.7 [1.8] and
11.5 [2.2] cm H2O, respectively; P = 0.010). There were no significant
differences in other parameters. (1)
2) A similar study by Sachidananda
et Al showed that the first-time insertion success rate of the Baska® mask was
21/24 (88%) when compared with the I-gel, which was 23/25 (92%) (p=0.585). The
insertion time of the Baska® mask was 14.9±6.2 s, whereas that of the I-gel was
14.7±4.4 s (p=0.877). The mean sealing pressure of the Baska® mask was
significantly higher when compared with the I-gel (28.9±3.5 vs. 25.9±2.5 cmH2O)
(p=0.001). (2)
3) According to Kara et Al,
compared to I-gel, the Baska mask required a longer time for insertion, and its
airway pressure was higher. The median (minimum-maximum) duration of LMA
insertion in the Baska and I-gel groups was 14 (6-25) and 7 (5-12) seconds, respectively
(z=-10.934; P<.001). The mean (SD) airway pressures were significantly
different between the two groups (15.8 [1.9] and 14.9 [1.7] cm/H2O for Baska
and I-gel, respectively; t=3.668; P<.001). Seal pressure was not
significantly different between the groups (0.08 [0.2] vs. 0.07 [0.2] cm/H2O in
the Baska and I-gel groups, respectively, (t=1.35; P=.194).
4) Based on a study by Agarwal et
Al,Oropharyngeal seal pressure was significantly higher at insertion
(31.70±3.67 cmH2O versus 27.3±2.93 cmH2O respectively, p value<0.001) and
after deflation of carboperitoneum (31.33±3.51 cmH2O and 28.20±3.07 cmH2O respectively,
p value < 0.001) in group B than group I. Time for achieving effective
airway in group B was comparable to that in group I (17.83±2.05 seconds
vs17.86±1.041 seconds respectively, p value=0.937). Ease of insertion of device
was comparable between the two groups (p value= 0.584). Upon fibreoptic
assessment, anatomical alignment of the device to larynx was comparable between
the two groups (p value =0.655). |