| CTRI Number |
CTRI/2024/10/075505 [Registered on: 18/10/2024] Trial Registered Prospectively |
| Last Modified On: |
17/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of three supraglottic airway devices, I-Gel, Laryngeal Mask Airway- Supreme and Laryngeal Mask Airway- Protector for giving anaesthesia |
|
Scientific Title of Study
|
Comparative efficacy of I-Gel, Laryngeal Mask Airway-Supreme and Laryngeal Mask Airway-Protector in Short Surgical Procedures under General Anaesthesia with Spontaneous Ventilation - A Randomised Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Damandeep Kaur |
| Designation |
PG resident |
| Affiliation |
Adesh Institute of Medical Sciences and Research |
| Address |
Department of Anaesthesiology and Intensive Care
Adesh institute of medical sciences and research Bathinda
Bathinda
PUNJAB
151001
India
Bathinda
PUNJAB
151001
India |
| Phone |
8360943292 |
| Fax |
|
| Email |
damandk98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Minnu Panditrao |
| Designation |
Professor |
| Affiliation |
Adesh Institute of Medical Sciences and Research |
| Address |
Department of Anaesthesiology and Intensive Care
Adesh institute of medical sciences and research Bathinda
Bathinda
PUNJAB
151001
India
Bathinda
PUNJAB
151001
India |
| Phone |
8699943250 |
| Fax |
|
| Email |
drmmprao@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Damandeep Kaur |
| Designation |
PG resident |
| Affiliation |
Adesh Institute of Medical Sciences and Research |
| Address |
Department of Anaesthesiology and Intensive Care
Adesh institute of medical sciences and research Bathinda
Bathinda
PUNJAB
151001
India
Bathinda
PUNJAB
151001
India |
| Phone |
8360943292 |
| Fax |
|
| Email |
damandk98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Adesh institute of medical sciences and research, Bathinda, Punjab 151001 |
|
|
Primary Sponsor
|
| Name |
Dr Damandeep Kaur |
| Address |
Adesh institute of medical sciences and research, Bathinda, Punjab 151001 |
| Type of Sponsor |
Other [Self] |
|
|
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 Damandeep Kaur |
Adesh institute of medical sciences and research |
Operation Theatre Complex, Department of Anaesthesiology and Intensive Care
Bathinda
PUNJAB |
8360943292
damandk98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Adesh University |
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 |
GENERAL ANESTHESIA WITH SPONTANEOUS VENTILATION USING SUPRAGLOTTIC AIRWAY DEVICES |
Comparison of induction for short surgical procedures (less than 1.5 hours) viz. I-Gel, LMA SUPREME and LMA PROTECTOR. Placement of the said SADs shall be carried out using the standard insertion technique that is advancement along the hard palate and soft palate into the posterior pharyngeal space. Only three attempts (of not more than 2 minutes) will be allowed. If unsuccessful, patient would be intubated with endotracheal tube and excluded from the study. The insertion of the SAD will be confirmed using waveform capnography. |
| Comparator Agent |
I-GEL |
Comparison of induction for short surgical procedures (less than 1.5 hours) viz. I-Gel, LMA SUPREME and LMA PROTECTOR. Placement of the said SADs shall be carried out using the standard insertion technique that is advancement along the hard palate and soft palate into the posterior pharyngeal space. Only three attempts (of not more than 2 minutes) will be allowed. If unsuccessful, patient would be intubated with endotracheal tube and excluded from the study. The insertion of the SAD will be confirmed using waveform capnography. |
| Comparator Agent |
LMA PROTECTOR |
Comparison of induction for short surgical procedures (less than 1.5 hours) viz. I-Gel, LMA SUPREME and LMA PROTECTOR. Placement of the said SADs shall be carried out using the standard insertion technique that is advancement along the hard palate and soft palate into the posterior pharyngeal space. Only three attempts (of not more than 2 minutes) will be allowed. If unsuccessful, patient would be intubated with endotracheal tube and excluded from the study. The insertion of the SAD will be confirmed using waveform capnography. |
| Comparator Agent |
LMA SUPREME |
Comparison of induction for short surgical procedures (less than 1.5 hours) viz. I-Gel, LMA SUPREME and LMA PROTECTOR. Placement of the said SADs shall be carried out using the standard insertion technique that is advancement along the hard palate and soft palate into the posterior pharyngeal space. Only three attempts (of not more than 2 minutes) will be allowed. If unsuccessful, patient would be intubated with endotracheal tube and excluded from the study. The insertion of the SAD will be confirmed using waveform capnography. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grading I ,II
Patients undergoing elective short surgeries less than 1.5hrs under general anaesthesia.
|
|
| ExclusionCriteria |
| Details |
Non Consenting Patient
BMI more than 30Kg/m2
Difficult airway MPC Class ≥3
Uncontrolled Co-morbid illness
H/O GERD, Hiatus Hernia
Musculo-skeletal Abnormalities Like Cervical Spine Deformities
Obstructive Sleep Apnea
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of I-Gel, LMA Supreme, and LMA Protector in maintaining a patent airway during short surgical procedures. |
Baseline(To)
1 min after insertion T1
3 min T2
5 min T3
15 min T4
30 min T5
45 min T6
60 min T7
75 min T8
90 min T9
105min T10
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the insertion characteristics, including ease and success rates, of the three supraglottic airway devices.
To assess safety parameters, such as seal pressures and incidence of complications, associated with I-Gel, LMA Supreme, and LMA Protector.
To analyze and compare hemodynamic stability and oxygenation levels achieved with each device during general anesthesia with spontaneous ventilation
|
Baseline(To)
1 min after insertion T1
3 min T2
5 min T3
15 min T4
30 min T5
45 min T6
60 min T7
75 min T8
90 min T9
105min T10
|
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
01/11/2024 |
| 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
|
While previous studies have compared different supraglottic airway devices or focused on other aspects, a dedicated investigation directly comparing these three commonly used devices could offer more precise guidance to clinicians in selecting the most suitable device for positive pressure ventilation in anesthetized patients. Therefore, our study aims to fill this gap by providing a comprehensive comparison among I-Gel, LMA-Supreme and LMA Protector, focusing on insertion ease, insertion time, placement attempts, airway leak pressure, and complications, ultimately aiming to optimize patient care and outcomes in anesthesia settings. |