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Clinical Trials/CTRI/2022/09/045949
CTRI/2022/09/045949Not yet recruitingNot Applicable

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

JIPMER1 site in 1 country140 target enrollmentStarted: September 30, 2022Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
JIPMER
Enrollment
140
Locations
1
Primary Endpoint
To compare success rate of passing endoscopy in the first attempt with LMA gastro and low flow Nasal cannula under TIVA.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Not Applicable

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 1} Age 18 to 60 yrs of either sex 2) ASA physical status I and II 3}Elective upper gastro intestinal endoscopic procedure.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

To compare success rate of passing endoscopy in the first attempt with LMA gastro and low flow Nasal cannula under TIVA.

Time Frame: Baseline

Secondary Outcomes

  • Endoscopy insertion time(Baseline)
  • interruption of procedure(End of the procedure)
  • Complication(30 minutes after the procedure)
  • Anaesthesiologist satisfaction(Likert scale)
  • Endoscopist satisfaction(Likert scale)

Investigators

Sponsor
JIPMER
Sponsor Class
Research institution and hospital

Study Sites (1)

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