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group, namely patients assessed for heart or lung transplantation in our hospital, the risk was especially high (unpublished data).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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.