| CTRI Number |
CTRI/2023/09/057309 [Registered on: 06/09/2023] Trial Registered Prospectively |
| Last Modified On: |
23/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Two ventilatory device are being compared in this study for ventilation in laparoscopic surgery done for removal of gall bladder. |
|
Scientific Title of Study
|
Comparison of clinical efficacy of laryngeal mask airway Protector with laryngeal mask airway Proseal for ventilation in patient undergoing laparoscopic cholecystectomy under general anaesthesia. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nidhi Kharb |
| Designation |
Post graduate resident |
| Affiliation |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive care, Vardhman Mahavir Medical College and Safdarjung hospital, Ansari Nagar, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9811472730 |
| Fax |
|
| Email |
nidhikharb4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nidhi Agrawal |
| Designation |
Professor |
| Affiliation |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive care, Vardhman Mahavir Medical College and Safdarjung hospital, Ansari Nagar, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9811030408 |
| Fax |
|
| Email |
nidhi.agrawal1970@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nidhi Agrawal |
| Designation |
Professor |
| Affiliation |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive care, Vardhman Mahavir Medical College and Safdarjung hospital, Ansari Nagar, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9811030408 |
| Fax |
|
| Email |
nidhi.agrawal1970@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung hospital, Ansari Nagar, New Delhi |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung hospital |
| Address |
Vardhman Mahavir Medical College and Safdarjung hospital, Ansari Nagar, New Delhi |
| 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 |
| Nidhi Kharb |
Vardhman Mahavir Medical College and Safdarjung hospital |
1st floor OT complex Anaesthesia Department Vardhman Mahavir Medical College and Safdarjung hospital, Ansari Nagar, New Delhi
New Delhi
DELHI |
9811472730
nidhikharb4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vardhman Mahavir Medical College and Safdarjung hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
laryngeal mask airway |
Laryngeal Mask Airway Protector is being compared with
Laryngeal Mask Airway Proseal in term of oropharyngeal seal pressure and other patient parameter in laparoscopic cholecystectomy.
Total duration of intervention is 18 months. |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
144 patients, in age group of 18 to 60 years,
American society of Anaesthesiologists (ASA) physical status I and II
undergoing laparoscopic cholecystectomy under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
Patients with anticipated difficult airway including:
Thyromental distance<6.5 cm, Upper lip bite test class<1, Mallampati class III and IV,
Restricted head and neck mobility, Mouth opening <3.5 cm, BMI>30kg/m2, Cervical spine pathology, High risk of aspiration. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Oropharyngeal leak pressure will be noted within 5 minutes after device insertion.
Other reading of oropharyngeal leak pressure will be taken after inflation & after deflation of carboperitoneum. |
Oropharyngeal leak pressure will be noted within 5 minutes after device insertion.
Other reading of oropharyngeal leak pressure will be taken after inflation & after deflation of carboperitoneum. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
insertion characteristics
1.NUMBER OF ATTEMPTS TAKEN FOR SUCCESSFUL INSERTION OF DEVICE
2.TIME FOR ACHIEVING EFFECTIVE VENTILATION
3.NUMBER OF PATIENTS REQUIRING MANIPULATION FOR ACHIEVING EFFECTIVE
VENTILATION AND TYPE OF MANIPULATION
4.EASE OF INSERTION OF DEVICE
5. EASE OF GASTRIC CATHETER INSERTION
6. SCORE REGARDING ANATOMICAL ALIGNMENT OF DEVICE
7.LEAK PERCENT
8.INTRAOPERATIVE AND POSTOPERATIVE ADVERSE EVENTS |
1.At time of insertion of device
2.Just after Insertion of Device
3.During Insertion
4.At time of insertion of device
5.During insertion of device.
6.Just after insertion
7.1 min after insertion, just before carboperitoneum, 5 mins after carboperitoneum, 5 mins after deflating carboperitoneum.
8.After completion of Surgery |
|
|
Target Sample Size
|
Total Sample Size="144"
Sample Size from India="144"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
20/10/2023 |
| 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
|
The study is a prospective ranadmoized interventional comparative study to compare clinical efficacy of Laryngeal Mask Airway Protector with Laryngeal mask airway Proseal for ventilation, in patients undergoing laparoscopic cholecystectomy under general anaesthesia, with hypothesis that the clinical efficacy of laryngeal mask airway Protector is equivalent to that of laryngeal mask airway ProSeal for ventilation in terms of oropharyngeal leak pressure in patients undergoing laparoscopic cholecystectomy under general anaesthesia. |