High-flow Nasal Oxygen Therapy for Advanced Endoscopy in High-risk Patients.

NCT06610461 | Completed FDA Device

• 1 other identifier: 2023P000245
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Anesthesia is crucial during upper GI endoscopy in order to improve the procedural conditions for the interventionist, increase the quality of examination and alleviate patient discomfort. However, sedation during endoscopy carries a serious risk of blood oxygen desaturation. This study aims to investigate the hypothesis if the application of high-flow nasal oxygen (HFNO) during high-risk gastroscopy reduces the risk of blood oxygen levels to drop below a defined threshold. Enrolled patients will be randomly assigned to either the control group, receiving standard care during endoscopy, or the intervention group, receiving HFNO therapy during the procedure. Throughout the intervention, vital parameters will be recorded. Care providers will be asked to answer a questionnaire that specifically evaluates the effect of HFNO on patient safety and the procedure.

Conditions

Hypoxemia During Surgery

Keywords

Nasal cannula, humidified oxygen, hypoxemia, endoscopy

Outcome Measures

Primary Outcomes (1)

• Additional actions had to be taken to ensure sufficient SpO2 oxygenation.

  A composite outcome including the occurrence of any airway manipulation due to inadequate ventilation, which may include jaw thrust or Esmarch maneuver, bag-mask ventilation, insertion of a nasogastric tube, laryngeal mask airway or endotracheal intubation or procedural interruption to treat inadequate ventilation. The necessity for airway manipulation is at the discretion of the anesthesia provider. Documentation of the primary outcome is conducted on paper sheets by the anesthesia provider including time, type and reason of upper airway manipulation.

  The primary outcome will be assessed in the time between start of induction of anesthesia and awakening until discharge from the procedural room, which is typically between 30 and 120 minutes

Secondary Outcomes (3)

• Satisfaction of care provider

  Satisfaction of the provider will be assessed at the end of the procedure upon discharge from the procedure room and will relate to the duration of the procedure, typically between 30 and 120 minutes

• Procedure interruption

  Procedure interruption will be assessed for the duration of the procedure, which is typically between 30 and 120 minutes

• Occurrence of hypoxemia

  The occurence of hypexmia will be assessed in the time between start of induction of anesthesia and awakening until discharge from the procedural room, which is typically between 30 and 120 minutes

Study Arms (2)

Control group

NO INTERVENTION

Supplemental oxygen throughout anesthesia in accordance with hospital guidelines.

Intervention group

ACTIVE COMPARATOR

HFNO- treatment

Device: HFNO-Treatment

Interventions

HFNO-Treatment DEVICE

The investigated intervention is the application of HFNO throughout a high-risk upper GI-endoscopy. Concentration of oxygen is 100%. Prior to induction, flow rate is set to 20 l/min and increased to 30 l/min if tolerated by the patient. After induction of anesthesia, flow rate is increased to 60 l/min and maintained throughout the anesthesia.

Intervention group

Eligibility Criteria

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

You may qualify if:

• Upper endoscopy (EGD, ERCP, EUC etc.) w/wo colonoscopy expected duration \> 15 min under MAC
• one or more of the following:
• Diagnosis of sleep apnea
• BMI ≥ 30 kg/m2
• Baseline SpO2 \< 96% or Requirement for long-term oxygen therapy
• BOSTN score ≥ 2
• BMI ≥ 30 kg/m2
• Observed apnea
• Observed loud Snoring
• Daytime Tiredness
• Neck circumference ≥ 16.5 inches in female, ≥ 17.5 inches in male

You may not qualify if:

• Known Pregnancy
• Known Current infection with COVID-19
• Planned general anesthesia

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Anesthesia, Critical Care and Pain Medicine Department at Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (7)

• Lin OS. Sedation for routine gastrointestinal endoscopic procedures: a review on efficacy, safety, efficiency, cost and satisfaction. Intest Res. 2017 Oct;15(4):456-466. doi: 10.5217/ir.2017.15.4.456. Epub 2017 Oct 23.

  PMID: 29142513 RESULT

• Elphick DA, Donnelly MT, Smith KS, Riley SA. Factors associated with abdominal discomfort during colonoscopy: a prospective analysis. Eur J Gastroenterol Hepatol. 2009 Sep;21(9):1076-82. doi: 10.1097/MEG.0b013e32832357b3.

  PMID: 19339891 RESULT

• Ahrens E, Tartler TM, Suleiman A, Wachtendorf LJ, Ma H, Chen G, Kendale SM, Kienbaum P, Subramaniam B, Wagner S, Schaefer MS. Dose-dependent relationship between intra-procedural hypoxaemia or hypocapnia and postoperative delirium in older patients. Br J Anaesth. 2023 Feb;130(2):e298-e306. doi: 10.1016/j.bja.2022.08.032. Epub 2022 Oct 1.

  PMID: 36192221 RESULT

• Qadeer MA, Lopez AR, Dumot JA, Vargo JJ. Hypoxemia during moderate sedation for gastrointestinal endoscopy: causes and associations. Digestion. 2011;84(1):37-45. doi: 10.1159/000321621. Epub 2011 Feb 8.

  PMID: 21304242 RESULT

• Lenglet H, Sztrymf B, Leroy C, Brun P, Dreyfuss D, Ricard JD. Humidified high flow nasal oxygen during respiratory failure in the emergency department: feasibility and efficacy. Respir Care. 2012 Nov;57(11):1873-8. doi: 10.4187/respcare.01575. Epub 2012 Mar 13.

  PMID: 22417844 RESULT

• Nay MA, Fromont L, Eugene A, Marcueyz JL, Mfam WS, Baert O, Remerand F, Ravry C, Auvet A, Boulain T. High-flow nasal oxygenation or standard oxygenation for gastrointestinal endoscopy with sedation in patients at risk of hypoxaemia: a multicentre randomised controlled trial (ODEPHI trial). Br J Anaesth. 2021 Jul;127(1):133-142. doi: 10.1016/j.bja.2021.03.020. Epub 2021 Apr 28.

  PMID: 33933271 RESULT

• Mazzeffi MA, Petrick KM, Magder L, Greenwald BD, Darwin P, Goldberg EM, Bigeleisen P, Chow JH, Anders M, Boyd CM, Kaplowitz JS, Sun K, Terrin M, Rock P. High-Flow Nasal Cannula Oxygen in Patients Having Anesthesia for Advanced Esophagogastroduodenoscopy: HIFLOW-ENDO, a Randomized Clinical Trial. Anesth Analg. 2021 Mar 1;132(3):743-751. doi: 10.1213/ANE.0000000000004837.

  PMID: 32398433 RESULT

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Center for Anesthesia Research Excellence (CARE), Division Director of Thoracic Anesthesia, Assistant Professor of Anesthesia

Model Details: This study will be a non-blinded, randomized, controlled trial comparing two study groups ("intervention" and "control"). Participants are assigned to one of two groups in parallel for the duration of the study.

Study Record Dates

• First Submitted: August 30, 2024
• First Posted: September 24, 2024
• Study Start: September 25, 2024
• Primary Completion: September 12, 2025
• Study Completion: September 12, 2025
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)