| CTRI Number |
CTRI/2022/09/045949 [Registered on: 27/09/2022] Trial Registered Prospectively |
| Last Modified On: |
23/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to compare two oxygen delivery devices LMA Gastro and Low flow nasal Cannula in patients undergoing Upper Gastro-Intestinal Endoscopic procedures under anaesthesia |
|
Scientific Title of Study
|
Comparison between Laryngeal Mask Airway- Gastro and Low flow nasal Cannula in patients undergoing Upper Gastro-Intestinal Endoscopic procedures under Total Intravenous Anaesthesia: A Randomized Control study |
| Trial Acronym |
RACE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Japhia S |
| Designation |
Junior Resident |
| Affiliation |
JiPMER -Autonomous Institute |
| Address |
Junior Resident
Department of Anaesthesiology and Critical care
JIPMER
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
|
| Fax |
|
| Email |
japhiajaph@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Stalin V |
| Designation |
Additional Professor |
| Affiliation |
JiPMER -Autonomous Institute |
| Address |
Additional Professor
Department of Anaesthesiology and Critical care
JIPMER
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
|
| Fax |
|
| Email |
drvstalin@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Japhia S |
| Designation |
Junior Resident |
| Affiliation |
JiPMER -Autonomous Institute |
| Address |
Junior Resident
Department of Anaesthesiology and Critical care
JIPMER
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
|
| Fax |
|
| Email |
japhiajaph@gmail.com |
|
|
Source of Monetary or Material Support
|
| JIPMER HOSPITAL, GORIMEDU, PRIYADARSHINI NAGAR, PUDUCHERRY |
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
JIPMER HOSPITAL
GORIMEDU,
PUDUCHERRY |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Japhia S |
JIPMER |
Room number 2
Division of Anaesthesiology
Department of Anaesthesiology and Critical care
JIPMER
Pondicherry
PONDICHERRY |
9486720299
japhiajaph@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comimitte JIPMER Puducherry |
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 |
Laryngeal Mask Airway- Gastro |
Total intravenous anaesthesia with the insertion of LMA gastro and the success rate of passing endoscopy in the frist attempt will be noted |
| Comparator Agent |
Low flow nasal Cannula |
Total intravenous anaesthesia with Low flow nasal cannula and the success rate of passing endoscopy in the frist attempt will be noted |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1} Age 18 to 60 yrs of either sex
2) ASA physical status I and II
3}Elective upper gastro intestinal endoscopic procedure
|
|
| ExclusionCriteria |
| Details |
1) ASA physical status ≥III
2) Hemodynamically unstable
patients – Heart rate <60beats per
minute and BP <90/60mmHg
3)Patients requiring Endotracheal
intubation
4)Patients with anticipated difficult
airway |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare success rate of passing endoscopy in the first attempt with LMA gastro and low flow Nasal cannula under TIVA. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Endoscopy insertion time |
Baseline |
| interruption of procedure |
End of the procedure |
| Endoscopist satisfaction |
Likert scale |
| Anaesthesiologist satisfaction |
Likert scale |
| Complication |
30 minutes after the procedure |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
30/09/2022 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Anaesthesia during gastroenterological procedures is a growing field. While the numbers of patients with severe comorbidities are rising constantly, gastrointestinal endoscopic interventions are moving closer to minimally invasive endoscopic surgery. Various airway techniques have been employed for endoscopic procedures, with an aim to optimise patient outcome by improving airway control and preventing hypoxia whilst avoiding the need for intubation. The LMA gastro is a newer supraglottic airway device, developed specifically for upper gastrointestinal endoscopy and intervention. Patients undergoing upper Gastro intestinal endoscopy typically receive either Total intravenous anaesthesia(TIVA) or general endotracheal anaesthesia (GETA). Patients receiving propofol based TIVA are at higher risk of sedation related complication. The LMA gastro Airway, a novel dual channel supraglottic airway technique, has a dedicated endoscopy channel which runs parallel along the separate airway channel with terminal cuffs. Use of LMA Gastro helps in avoiding sedation related airway complications like apnea, desaturation and also gives the advantage of initiating rescue measures like positive pressure ventilation without interrupting the endoscopic procedure. |