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NCT06168682Completed

Nasal CPAP - The Treatment IMpact on Oxygenation in High-risk Patients During Deep Sedation for Endoscopy

The Effect of Nasal Continuous Positive Airway Pressure on Oxygenation in High-risk Patients Having Gastrointestinal Endoscopy Under Deep Sedation

Source: ClinicalTrials.gov · Last updated 9 Dec 2024

Brief summary (registry, in English)

Deep sedation during gastrointestinal endoscopy in patients with cardiopulmonary risk factors such as respective co-morbidities or also morbid obesity is challenging. Those high-risk patients are at risk of upper airway obstruction and hypoxemia. Nasal continuous positive airway pressure may help to decrease the incidence of peri-interventional hypoxemia. However, data on nasal continuous positive airway pressure in high-risk patients having gastrointestinal endoscopy are scarce; only one randomized trial on gastroscopy in obese patients is available (Kang et al. J Anesth 2021). In a very high-risk group, namely patients assessed for heart or lung transplantation in our hospital, the risk was especially high (unpublished data). Aim of this trial is the effect of nasal continuous positive airway pressure - compared to nasal oxygen insufflation - on the incidence of hypoxemia in high-risk patients having gastrointestinal endoscopy in deep sedation. The investigators hypothesize that nasal continuous positive airway pressure - compared to nasal oxygen insufflation - reduces the incidence of hypoxemia in high-risk patients having gastrointestinal endoscopy in deep sedation.

Status (registry)
Completed
Study type
Interventional
Enrollment
158 (actual)
First submitted
5 Dec 2023
Start date
1 Nov 2023
Primary completion date
30 May 2024
Lead sponsor
Universitätsklinikum Hamburg-Eppendorf
Diseases
Obesity
NCT number
NCT06168682

What you commit to

  • Study type: Interventional
  • Participants enrolled: 158
  • From 1 Nov 2023 to the primary completion date, 30 May 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Cognitive impairment, that makes consent to study impossible
  • Known but untreated heart disease (e.g. persistent foramen ovale (PFO), recent congestive heart failure), complicating comparability within groups

Age

  • Age \< 18 years

Other

  • Pregnancy

Who the study is looking for

  • Adult and obese high-risk patients (ASA class ≥3 and/or BMI ≥30 kg/m², in accordance with the current WHO definition of obesity) scheduled for elective gastrointestinal endoscopy with deep sedation.

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine
Coordinator of this site? Confirm its status
HamburgGermanyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.