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Clinical Trials/CTRI/2025/06/088653
CTRI/2025/06/088653
Not yet recruiting
Not Applicable

Comparison of high flow nasal cannula versus standard oxygen therapy assisted sedation during endoscopic retrograde cholangiopancreatography

Army hospital Research and Referral1 site in 1 country80 target enrollmentStarted: June 24, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
80
Locations
1
Primary Endpoint
Incidence of hypoxemia spo2 less than 95% for 10 seconds and severe hypoxemia spo2 less than 90% for 10seconds during procedural time

Overview

Brief Summary

ERCP is a common diagnostic and therapeutic procedure often require sedation. The incidence of hypoxemia noted during ERCP under sedation presumably because lengthy procedure, endoscopist share common airway and is performed in semiprone or pronr postion. The choice of oxygen method during sedation play a crucial role in safety and outcomes as well as patient comfort.

Use of HFNC is widened to critical care and day care procedures in non operating room anesthesia settings under sedation.

Very few similar studies conducted in Indian population .

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • ASA Physical status class I-III , schedule for elective ERCP under sedation.

Exclusion Criteria

  • Age less than 18yrs or more than 70yrs with coexisting respiratory, cardiac illness, dementia, cognitive disorder, pregnancy, allergic to Propofol and Fentanyl, anticipated difficult intubation , tracheostomized, emergency ERCP.

Outcomes

Primary Outcomes

Incidence of hypoxemia spo2 less than 95% for 10 seconds and severe hypoxemia spo2 less than 90% for 10seconds during procedural time

Time Frame: At baseline and T1,5,10,15,20,30,45,60,75(minutes) and PACU

Secondary Outcomes

  • Total Propofol consumption(At end of procedure in PACU)
  • Need of assisted ventilation(During procedure in between when required & requirement episodes will be recorded)
  • Airway manipulation(During procedure & episodes will be recorded)
  • Endoscopist & Patient satisfaction(At end of Procedure)
  • Total procedural duration(At end of procedure)

Investigators

Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr D R Famara

Army Hospital Research and Referral, Delhi

Study Sites (1)

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