| CTRI Number |
CTRI/2024/05/067856 [Registered on: 24/05/2024] Trial Registered Prospectively |
| Last Modified On: |
17/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Fitting of airway device on application of pressure. |
|
Scientific Title of Study
|
The influence of positive end expiratory pressure on leakage and oxygenation during ventilation with laryngeal mask airway:A randomized 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 |
Nagma Qadir |
| Designation |
junior resident( academic) |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of Anaesthesiology and critical care Medicine,Neurosurgery Ot Complex,1st Floor Ward Block,IGIMS,Sheikhpura,Patna,Bihar,800014,India
Patna
BIHAR
800014
India |
| Phone |
7488526477 |
| Fax |
|
| Email |
nagmaqadir786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Swati |
| Designation |
Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences,Patna |
| Address |
Department of Anaesthesiology and critical care Medicine,Neurosurgery ot Complex,Fist floor,Ward Block,IGIMS Patna,Sheikhpura,Patna,800014,Bihar,India
Patna
BIHAR
800014
India |
| Phone |
9113463130 |
| Fax |
|
| Email |
swatipgi2006@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Swati |
| Designation |
Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences,Patna |
| Address |
Department of Anaesthesiology and critical care Medicine,Neurosurgery ot Complex,Fist floor,Ward Block,IGIMS Patna,Sheikhpura,Patna,800014,Bihar,India
Patna
BIHAR
800014
India |
| Phone |
9113463130 |
| Fax |
|
| Email |
swatipgi2006@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and Critical care Medicine,Neurosurgery ot Complex,First floor,Ward Block,IGIMS,PATNA,Sheikhpura,Patna,800014,Bihar,India |
|
|
Primary Sponsor
|
| Name |
Dr Nagma Qadir |
| Address |
Department of Anaesthesiology and critical care Medicine,Neurosurgery ot Complex,IGIMS Patna,Sheikhpura,Patna,800014,Bihar,India |
| 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 Nagma Qadir |
Indira Gandhi Institute of Medical Sciences,Patna |
Department of Anaesthesiology and Critical Care Medicine,Neurosurgery Ot Complex,First floor,Ward Block,IGIMS Patna,Sheikhpura,Patna-800014,Bihar,India
Patna
BIHAR |
7488526477
nagmaqadir786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES, PATNA |
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 |
Application of PEEP |
After insertion of Laryngeal mask airway a PEEP of 4 millibar is applied during intraoperative period. |
| Comparator Agent |
No PEEP is applied after LMA Insertion. |
After introduction of LMA no PEEP is applied during intraoperative period ventilation. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1) Patient undergoing elective surgery with general anaesthesia and ventilation with laryngeal mask
2)ASA 1 or 2
3)Age less than 18 years
|
|
| ExclusionCriteria |
| Details |
Patient at risk of aspiration
Gastroesophageal reflux disease
BMI percentile 95 or greater
Surgical procedures in prone or lateral positions and laproscopic surgeries |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find difference between PEEP and ZEEP with respect to gas leakage in patients receiving positive pressure ventilation with ProSeal LMA mask. |
Intraoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To clearify the potential benefit or harm to PEEP application during Positive pressure with ventilation with
Proseal LMA mask |
Intraoperative period |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
15/06/2024 |
| 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="2"
Months="0"
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
|
To clarify the potential benefit or harm to PEEP application during positive pressure ventilation with a Proseal LMA mask,we plan to compare the effect of PEEP versus ZEEP on gas leakage and oxygenation.we hypothesized that a PEEP of 4cm.This study will be prospective,controlled,randomized,single blinded conducted at a single centre.Using a computer generated randomization system,p atients were randomized to positive pressure ventilation with zero end -expiratory pressure or a PEEP of 4mbar.Age will be in between 1 to 18 year.Gas leakage are determined by seeing the difference in tidal delivered using values provided by machine and the presence of audible gas leakage.Based on that ,the qualityof ProSeal LMAmask placement and adequacy of ventilation would also be evaluated by the anaesthesiologist. |