| CTRI Number |
CTRI/2024/07/071479 [Registered on: 29/07/2024] Trial Registered Prospectively |
| Last Modified On: |
29/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to comparatively evaluate peak inspiratory pressure and dynamic compliance between ambu auragain laryngeal mask airway and endotracheal tube |
|
Scientific Title of Study
|
Comparison of peak inspiratory pressure and dynamic compliance between ambu auragain laryngeal mask airway and endotracheal tube |
| 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 Kamakshi Garg |
| Designation |
Professor Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of anaesthesia , First Floor , Dayanand Medical College And Hospital Civil Lines Ludhiana
Ludhiana
PUNJAB
141001
India |
| Phone |
9814444121 |
| Fax |
|
| Email |
drkamakshigarg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhideep Singh Sandhu |
| Designation |
PG Resident Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of anaesthesia Dayanand Medical College And Hospital Tagore Nagar Civil lines Ludhiana PG hostel Room no. 176 Ludhiana Punjab
Ludhiana
PUNJAB
141001
India |
| Phone |
8968828829 |
| Fax |
|
| Email |
singhabhideep10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhideep Singh Sandhu |
| Designation |
PG Resident Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of anaesthesia Dayanand Medical College And Hospital Tagore Nagar Civil lines Ludhiana PG hostel Room no. 176 Ludhiana Punjab
Ludhiana
PUNJAB
141001
India |
| Phone |
8968828829 |
| Fax |
|
| Email |
singhabhideep10@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayanand Medical College and Hospital Tagore Nagar, Civil lines ,Ludhiana 141001 Punjab India |
|
|
Primary Sponsor
|
| Name |
Dayanand Medical College and Hospital |
| Address |
Tagore Nagar,Civil lines,Ludhiana,141001 Punjab |
| 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 Kamakshi Garg |
Dayanand Medical College and Hospital |
Department of anaesthesia , Dayanand Medical College And Hospital, Tagore Nagar, Civil Lines Ludhiana
Ludhiana
PUNJAB |
9814444121
drkamakshigarg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and ethical committee,Dayanand Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K80-K87||Disorders of gallbladder, biliary tract and pancreas, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ambu AuraGain |
Patients in Group A will be given Ambu Auragain to secure the airway. |
| Comparator Agent |
Endotracheal tube |
Patients in Group E will be given Endotracheal tube to secure the airway |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults of either gender
2. Age between 18 to 65 years
3. Patients undergoing elective laparoscopic cholecystectomy
4. American Society of Anaesthesiologists Physical Status (ASA) I, II and III patients
5. BMI less than 35 kg/m2
|
|
| ExclusionCriteria |
| Details |
1. Anticipated anatomical or physiological difficult airway
2. Pregnant patients
3. Presence of significant acute or chronic lung disease
4. Presence of significant acute or chronic cardiac disease
5. Patient refusal to participate in study |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in peak inspiratory pressure and dynamic compliance with the use of either Ambu AuraGain or endotracheal tube . |
Patients will be observed at baseline after induction of anaesthesia , 5 minutes after positioning of patient and before pneumoperitoneum , 5 minutes post pneumoperitoneum creation ,10 minutes post pneumoperitoneum and then every 10 minutes upto 180 minutes after induction of anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in haemodynamic parameters ,ease of insertion of airway device & post operative complications if any with the use of airway device whether Ambu AuraGain or endotracheal tube. |
Patients will be observed at baseline, immediately after insertion, at 5 minutes,10 minutes,20 minutes,30 minutes & then every 15 minutes upto 180 minutes after induction of anaesthesia.Post operative complications will be recorded till the discharge of the patient from the post anaesthesia care unit. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
09/08/2024 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [singhabhideep10@gmail.com].
- For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Respiratory mechanics are significantly altered in patients who are undergoing laparoscopic surgeries. Pneumoperitoneum created during laparoscopic cholecystectomy alters respiratory system mechanics which may be deleterious in patients with compromised pulmonary function. Therefore a proper choice and use of airway device whether Ambu AuraGain laryngeal mask airway or endotracheal tube can help avoid respiratory and haemodynamic complications. A prospective, randomised, interventional study will be conducted on 70 ASA I,II and III patients undergoing elective laparoscopic cholecystectomy under general anaesthesia. Enrolled patients will be randomly allocated into two groups. In Group A, Ambu AuraGain will be inserted while in Group E, endotracheal tube will be inserted. Peak inspiratory pressure, dynamic compliance ,haemodynamic parameters, ease of insertion of airway device and post operative complications with the use of airway device will be noted in both the groups. |