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

NCT06168682 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2024-12-09

No results posted yet for this study

Summary

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group, namely patients assessed for heart or lung transplantation in our hospital, the risk was especially high (unpublished data).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.

Conditions

  • Continuous Positive Airway Pressure
  • Endoscopy
  • Oxygenation
  • Obesity

Interventions

DEVICE

SuperNO2VA™ Et by Vyaire Medical, Inc.

SuperNO2VA™ Et provides a nCPAP between 3 to 10 cmH20 using a oxygenflowrate of 6l/O2

DEVICE

nasal oxygen cannula

Standard Operating Procedure (SOP) for endoscopy: Using a nasal oxygen cannula with oxygenflowrate of 6l/O2

Sponsors & Collaborators

  • Universitätsklinikum Hamburg-Eppendorf

    lead OTHER

Principal Investigators

  • Karlo R Huenerbein, Dr. med. · Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2024-05-30
Completion
2024-06-30

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06168682 on ClinicalTrials.gov