COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

High-flow Nasal Oxygen Versus Face Mask or Nasal Cannula for Advanced Endoscopy in High-risk Patients

Quick Facts

Study Start:2024-09-25
Study Completion:2025-09-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06610461

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Upper endoscopy (EGD, ERCP, EUC etc.) w/wo colonoscopy expected duration \> 15 min under MAC
  2. * one or more of the following:
  3. * Diagnosis of sleep apnea
  4. * BMI ≥ 30 kg/m2
  5. * Baseline SpO2 \< 96% or Requirement for long-term oxygen therapy
  6. * BOSTN score ≥ 2
  7. * BMI ≥ 30 kg/m2
  8. * Observed apnea
  9. * Observed loud Snoring
  10. * Daytime Tiredness
  11. * Neck circumference ≥ 16.5 inches in female, ≥ 17.5 inches in male
  1. * Known Pregnancy
  2. * Known Current infection with COVID-19
  3. * Planned general anesthesia

Contacts and Locations

Study Locations (Sites)

Anesthesia, Critical Care and Pain Medicine Department at Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States

Collaborators and Investigators

Sponsor: Beth Israel Deaconess Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-25
Study Completion Date2025-09-12

Study Record Updates

Study Start Date2024-09-25
Study Completion Date2025-09-12

Terms related to this study

Keywords Provided by Researchers

  • Nasal cannula, humidified oxygen, hypoxemia, endoscopy

Additional Relevant MeSH Terms

  • Hypoxemia During Surgery