High Flow Nasal Oxygen Versus Standard Nasal Oxygen in Endoscopic Retrograde Cholangiopancreatography Under Sedation

NCT06689033 | Completed

• 1 other identifier: E2-23-4070
• Study Type: observational
• Target: 187
• Locations: 1 country
• Sites: 1

Brief Summary

The administration of supplemental oxygen using a standard nasal cannula is the current standard of care for patients undergoing sedation for gastrointestinal endoscopic procedures. Endoscopic Retrograde Cholangio Pancreatography can be particularly challenging for anesthesiologists due to the increased difficulty in airway access when performed in the prone position. High-flow nasal oxygen is a non-invasive oxygen therapy system that can provide heated and humidified air containing oxygen at a high flow rate.This study aims to compare the effectiveness of High Flow Nasal Oxygen versus standard nasal oxygen in preventing hypoxemia in patients undergoing deep sedation during ERCP procedures.

Conditions

Cholangiopancreatography, Endoscopic Retrograde; Hypoxia; Sedation

Keywords

HFNO; sedation; prone position; Cholangiopancreatography, Endoscopic Retrograde

Outcome Measures

Primary Outcomes (1)

• Oxygen saturation SpO2 levels of the cases in %

  Each patient was monitored with an oxygen saturation probe and SpO2 levels of the cases were recorded before induction of sedation and every 5 minutes, throughout the procedure. Hypoxemia was detected.

  Oxygen saturation levels were recorded before induction and every 5 minutes throughout the procedure that lasted around 30 minutes.

Secondary Outcomes (1)

• Number of interventions over procedure time (number)

  Number of maneuvers performed throughout the procedure, that lasted around 30 minutes were recorded.

Other Outcomes (2)

• Systolic, diastolic and mean blood pressures were recorded

  Blood pressure monitorization was performed before induction and every 5 minutes throughout the procedure that lasted around 30 minutes.

• Heart beat was recorded in beats per minute

  Heart beat monitorization was performed before induction and every 5 minutes throughout the procedure that lasted around 30 minutes.

Study Arms (2)

Group 1: Patients sedated for ERCP, receiving nasal oxygen

Nasal Oxygen, preoxygenation with 100% oxygen for 3 min with an oxygen flow rate of 8 L.min-1 via a nasal cannula before induction and 100% oxygen with a flow rate of 5 L.min-1 throughout the procedure.

Group 2: Patients sedated for ERCP receiving high flow nasal oxygen

High flow nasal oxygen, preoxygenation with 100% oxygen with a flow rate of 40 L.min-1 for 3 min before induction and received 50% oxygen with a flow rate of 50 L.min-1.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients scheduled for ERCP procedure under sedation in Ankara City Hospital's Gastrointestinal Endoscopy Colonoscopy Unit are included.

You may qualify if:

• Voluntary patients over 18 years of age
• ASA (American Society of Anaesthesiologists) I-IV risk scores

You may not qualify if:

• Patients with altered mental status, dementia, cognitive disorders
• Intubation
• Tracheostomies
• Need for oxygen therapy due to preexisting disease
• Pregnancy
• Recent history of nasal bleeding
• Allergy to propofol

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital, Department of Anesthesiology

Ankara, 06800, Turkey (Türkiye)

Location

Related Publications (8)

• Carron M, Tamburini E, Safaee Fakhr B, De Cassai A, Linassi F, Navalesi P. High-flow nasal oxygenation during gastrointestinal endoscopy. Systematic review and meta-analysis. BJA Open. 2022 Oct 18;4:100098. doi: 10.1016/j.bjao.2022.100098. eCollection 2022 Dec.

  PMID: 37588780 BACKGROUND

• Sawase H, Ozawa E, Yano H, Ichinomiya T, Yano R, Miyaaki H, Komatsu N, Ayuse T, Kurata S, Sato S, Pinkham MI, Tatkov S, Ashizawa K, Nagata K, Nakao K. Respiratory support with nasal high flow without supplemental oxygen in patients undergoing endoscopic retrograde cholangiopancreatography under moderate sedation: a prospective, randomized, single-center clinical trial. BMC Anesthesiol. 2023 May 8;23(1):156. doi: 10.1186/s12871-023-02125-w.

  PMID: 37158818 BACKGROUND

• Zhang YX, He XX, Chen YP, Yang S. The effectiveness of high-flow nasal cannula during sedated digestive endoscopy: a systematic review and meta-analysis. Eur J Med Res. 2022 Feb 24;27(1):30. doi: 10.1186/s40001-022-00661-8.

  PMID: 35209948 BACKGROUND

• Douglas N, Ng I, Nazeem F, Lee K, Mezzavia P, Krieser R, Steinfort D, Irving L, Segal R. A randomised controlled trial comparing high-flow nasal oxygen with standard management for conscious sedation during bronchoscopy. Anaesthesia. 2018 Feb;73(2):169-176. doi: 10.1111/anae.14156. Epub 2017 Nov 24.

  PMID: 29171661 BACKGROUND

• Corral-Blanco M, Sayas-Catalan J, Hernandez-Voth A, Rey-Terron L, Villena-Garrido V. High-Flow Nasal Cannula Therapy as an Adjuvant Therapy for Respiratory Support during Endoscopic Techniques: A Narrative Review. J Clin Med. 2023 Dec 22;13(1):81. doi: 10.3390/jcm13010081.

  PMID: 38202089 BACKGROUND

• Cha B, Lee MJ, Park JS, Jeong S, Lee DH, Park TG. Clinical efficacy of high-flow nasal oxygen in patients undergoing ERCP under sedation. Sci Rep. 2021 Jan 11;11(1):350. doi: 10.1038/s41598-020-79798-7.

  PMID: 33432035 BACKGROUND

• Lee MJ, Cha B, Park JS, Kim JS, Cho SY, Han JH, Park MH, Yang C, Jeong S. Impact of High-Flow Nasal Cannula Oxygenation on the Prevention of Hypoxia During Endoscopic Retrograde Cholangiopancreatography in Elderly Patients: A Randomized Clinical Trial. Dig Dis Sci. 2022 Aug;67(8):4154-4160. doi: 10.1007/s10620-021-07272-z. Epub 2021 Nov 2.

  PMID: 34727281 BACKGROUND

• Kim SH, Bang S, Lee KY, Park SW, Park JY, Lee HS, Oh H, Oh YJ. Comparison of high flow nasal oxygen and conventional nasal cannula during gastrointestinal endoscopic sedation in the prone position: a randomized trial. Can J Anaesth. 2021 Apr;68(4):460-466. doi: 10.1007/s12630-020-01883-2. Epub 2021 Jan 6.

  PMID: 33403549 BACKGROUND

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ezgi Erkilic, Associate Professor

  Ankara Bilkent City Hospital, Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: November 14, 2024
• Study Start: April 1, 2023
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Beginning right after publication and ending 2 years after the publication of results
• Access Criteria: Data required for research and meta-analysis will be shared.

Locations

TU (1)