| CTRI Number |
CTRI/2024/07/070072 [Registered on: 05/07/2024] Trial Registered Prospectively |
| Last Modified On: |
04/07/2024 |
| 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
|
In patients of 2 to 12 years, with laryngeal mask airway device based general anaesthesia, with and without the application of positive end expiratory pressure and calculating leak volume in time intervals of 5 mins, 15 mins, 30 mins, and 1 hour to assess the affectiveness of ventilation. |
|
Scientific Title of Study
|
To compare the leak volume with and without the application of positive end-expiratory pressure with I-gel based general anaesthesia in pediatric patients: A Randomised Control 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 |
Dr Sriya V Tallapragada |
| Designation |
MD Anaesthesiology |
| Affiliation |
KAHERs Jawaharlal Nehru Medical College |
| Address |
Department of Anaesthesiology
Jawaharlal Nehru Medical College
Belagavi 590010
Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
8054262555 |
| Fax |
|
| Email |
svtallapragada@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh S Mane |
| Designation |
Professor & HOD Anaesthesiology |
| Affiliation |
KAHERs Jawaharlal Nehru Medical College |
| Address |
Department of Anaesthesiology
Jawaharlal Nehru Medical College
Belagavi 590010
Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
8054262555 |
| Fax |
|
| Email |
drrajeshmane@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sriya V Tallapragada |
| Designation |
MD Anaesthesiology |
| Affiliation |
KAHERs Jawaharlal Nehru Medical College |
| Address |
Department of Anaesthesiology
Jawaharlal Nehru Medical College
Belagavi 590010
Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
8054262555 |
| Fax |
|
| Email |
svtallapragada@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLEs Prabhakar Kore Hospital, Jawaharlal Nehru Medical College
Nehru Nagar, Belagavi
Belgaum
Karnataka
India
590010 |
|
|
Primary Sponsor
|
| Name |
Dr Sriya V Tallapragada |
| Address |
Department of Anaesthesiology
Jawaharlal Nehru Medical College
Belagavi 590010
Karnataka |
| 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 Sriya V Tallapragada |
KLE Dr Prabhakar Kore Hospital and Medical Research Centre, Belagavi |
Dr. Sriya V Tallapragada
Department of Anaesthesiology
Jawaharlal Nehru Medical College
Nehru Nagar
Belagavi
590010
Belgaum
KARNATAKA |
08054262555
svtallapragada@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics 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 |
| Comparator Agent |
Application of positive end expiratory pressure |
Application of positive end expiratory pressure with laryngeal mask airway based general anaesthesia in paediatric patients, and calculating leak volume in time intervals of every 15 mins, over one hour of surgical procedure. |
| Intervention |
The application of positive end expiratory pressure with I gel based general anaesthesia in paediatric patients. |
After obtaining informed consent and inducing patient under I-gel based general anaesthesia, patients will be divided into two groups, Group A where PEEP of 5cm of H2O will be added to pressure controlled ventilation and Group B where no PEEP will be applied. Assessment of leak in both groups will be done by recording leak volumes. The patients will be monitored throughout the procedure. Vitals were noted and recorded. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Day(s) |
| Age To |
12.00 Day(s) |
| Gender |
Both |
| Details |
Age 2 to 12 years of age
ASA l and ll
Elective Surgeries
Consent given |
|
| ExclusionCriteria |
| Details |
Airway deformities (congenital)
Risk of aspiration
Preoperative sore throat or upper respiratory tract infection
Allergy to local anaesthetic |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the leak volume with and without the application of positive end expiratory pressure with I-gel based general anaesthesia in pediatric patients |
To compare leak volume at intervals of 5 minutes, 30 minutes, and 1 hour. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare end tidal carbon dioxide and peak inspiratory pressure with I-gel based general anaesthesia in paediatric patients |
To compare end tidal carbon dioxide and peak inspiratory pressure at intervals of 5 minutes, 30 minutes, and 1 hour. |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/07/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 term positive end expiratory pressure (PEEP) refers to pressure in the airway at the end of passive expiration that exceeds atmospheric pressure. The use of PEEP has mainly been reserved to recruit or stabilise lung units and improve oxygenation in patients. I-gel is an innovative second generation supraglottic airway device, designed to create a non-inflatable, anatomical seal of the pharyngeal, laryngeal, and perilaryngeal structures whilst avoiding compression trauma. Although there are numerous adult studies on the effectiveness and safety of I-gel with and without PEEP pressure, we sought to assess the same efficacy in children. This study is a one year randomised control trial. |