Clinical trial NCT06610461: High-flow Nasal Oxygen Therapy for Advanced Endoscopy in High-risk Patients.
Official title: High-flow Nasal Oxygen Versus Face Mask or Nasal Cannula for Advanced Endoscopy in High-risk Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypoxemia During Surgery
Keywords: Nasal cannula, humidified oxygen, hypoxemia, endoscopy
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Detailed description: This non-blinded, randomized controlled trial compares two study groups, the interventional and control group, to investigate whether HFNO-treatment reduces the risk of hypoxemia during peri-interventional high-risk upper GI endoscopy.

The randomization schema is developed by an unblinded statistician using SAS (Statistical system) and uploaded to the REDCap randomization module, enabling delegated team members to generate sequential allocations for enrolled subjects.

Patients assigned to the control group will receive supplemental oxygen throughout anesthesia in accordance with hospital guidelines, either using a standard nasal cannula or procedural oxygen mask (POM). The choice of supplemental oxygen delivery, as well as oxygen flow rates, are at the discretion of the anesthesia provider. Post-anesthesia, patients will be transferred to the recovery room with either the standard nasal cannula or procedural oxygen mask at a flow rate determined by the anesthesia provider.

Patients assigned to the intervention group will receive humidified oxygen throughout anesthesia in order to assess the effect of HFNO. High-flow nasal cannula (Fisher \& Paykel Optiflow) are connected prior to induction of anesthesia, allowing for different flow rates and oxygen concentration to be administered according to the study protocol. The oxygen concentration of the delivered gas for the trial is 100%. Prior to induction, flow rate will be set to 20 liters per minute and increased to 30 liters per minute if tolerated by the patient. After induction of anesthesia, flow rate will be increased to 60 liters per minute and maintained throughout anesthesia. After anesthesia, the high-flow nasal cannula will be exchanged to a standard nasal cannula and the patient will be transferred to the recovery room at which point the flow rate will be determined by the anesthesia provider.

The decision to discontinue the intervention of the study is entirely at the discretion of the attending anesthesiologist. Alternative means of supplemental oxygen delivery, such as nasal cannula or oxygen mask, may be considered by the attending anesthesiologist. If the intervention is discontinued, the rationale for the decision is documented for later analysis.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Additional actions had to be taken to ensure sufficient SpO2 oxygenation.
timeFrame: 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:
measure: Satisfaction of care provider
timeFrame: 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
measure: Procedure interruption
timeFrame: Procedure interruption will be assessed for the duration of the procedure, which is typically between 30 and 120 minutes
measure: Occurrence of hypoxemia
timeFrame: 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
Other outcomes:
Locations:
city: Boston
country: United States
facility: Anesthesia, Critical Care and Pain Medicine Department at Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
References:
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citation: 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.
citation: 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.