| CTRI Number |
CTRI/2026/01/100881 [Registered on: 12/01/2026] Trial Registered Prospectively |
| Last Modified On: |
28/12/2025 |
| 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
|
A clinical study comparing the time taken to insert a nasogastric tube through two primary devices in patients undergoing laparoscopic surgeries |
|
Scientific Title of Study
|
COMPARISON OF RYLES TUBE INSERTION TIME USING LMA PROTECTOR VERSUS I-GEL PLUS IN LAPAROSCOPIC SURGERIES |
| 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 Meghna Yadav |
| Designation |
Junior Resident |
| Affiliation |
Guru Gobind Singh Medical College and Hospital,Faridkot |
| Address |
Department of Anaesthesiology, Guru Gobind Singh Medical College and Hospital,Faridkot, Punjab,India
Faridkot
PUNJAB
151203
India |
| Phone |
9041089334 |
| Fax |
|
| Email |
meghnayadav1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gurkaran Kaur Sidhu |
| Designation |
Associate professor |
| Affiliation |
Baba farid university of health sciences |
| Address |
Department of Anaesthesia and Intensive Care
Faridkot
PUNJAB
151203
India
Faridkot
PUNJAB
151203
India |
| Phone |
09876766522 |
| Fax |
|
| Email |
sugarsidhu2007@outlook.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meghna Yadav |
| Designation |
Junior Resident |
| Affiliation |
Guru Gobind Singh Medical College and Hospital,Faridkot |
| Address |
Department of Anaesthesiology, Guru Gobind Singh Medical College and Hospital,Faridkot, Punjab,India
Faridkot
PUNJAB
151203
India |
| Phone |
9041089334 |
| Fax |
|
| Email |
meghnayadav1996@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Guru Gobind Singh Medical College Hospital,Faridkot, Punjab,151203 India |
|
|
Primary Sponsor
|
| Name |
Guru Gobind Singh Medical College and Hospital,Faridkot |
| Address |
Department of Anaesthesiology, Guru Gobind Singh Medical College Hospital,Faridkot, Punjab,151203 India |
| Type of Sponsor |
Government 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 Meghna Yadav |
Guru Gobind Singh Medical College and Hospital,Faridkot |
Department of Anaesthesiology, Guru Gobind Singh Medical College and Hospital,Faridkot, Punjab
Faridkot
PUNJAB |
9041089334
meghnayadav1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Guru Gobind Singh Medical College |
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 |
| Comparator Agent |
I-gel plus supraglottic airway device |
The moment the lubricated ryles tube is introduced into the gastric channel of the airway until its correct placement in the stomach only once at induction |
| Intervention |
LMA Protector supraglottic airway device |
The moment the lubricated ryles tube is introduced into the gastric channel of the airway until its correct placement in the stomach only once at induction |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anesthesiologists (ASA) grade I and II.
Patient giving valid, informed and written consent.
Patients weighting between 50-90Kg posted for elective laparoscopic abdominal surgery under General Anaesthesia. |
|
| ExclusionCriteria |
| Details |
Patients having high risk of aspiration (symptomatic gastro-esophageal reflux
disease & hiatus hernia).
Patients having obstructive sleep apnea.
Patients having recent (last 10days) upper respiration tract infection.
Patients having previous head & neck surgery or radiotherapy.
Patients having restricted mouth opening or anticipated difficult airway.
Any facial, laryngeal and pharyngeal anatomy problem |
|
|
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 |
| Time Taken for Successful Insertion of Ryles tube |
At Baseline only |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ease of Insertion of Ryles tube |
The moment the lubricated tube is introduced into the gastric channel of the airway until its correct placement in the stomach |
| Ease of successful insertion of ryles tube |
The moment the lubricated tube is introduced into the gastric channel of the airway until its correct placement in the stomach |
| Oropharyngeal leak pressure |
The moment the lubricated airway is introduced until its correct placement |
| Leak percentage through airway |
5 minutes post device insertion |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/02/2026 |
| 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
|
Supraglottic airway devices are increasingly being used as an excellent alternative to mask ventilation and tracheal intubation with fewer complications. The airway devices with gastric access tubes are increasingly being used in surgery requiring general anesthesia and positive airway ventilation. To ensure patient safety it is important that their advantages and limitations must be studied. The hunt is on for a supraglottic airway device that combines the benefits of existing supraglottic airway devices with aspiration protection. To comparison of time taken in insertion of Ryle’s tube using LMA Protector versus I-gel plus in laparoscopic surgeries. |