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

NCT06168682 | Completed

• 1 other identifier: 14116209135
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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group, namely patients assessed for heart or lung transplantation in our hospital, the risk was especially high (unpublished data).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

Outcome Measures

Primary Outcomes (1)

• Incidence of hypoxemia

  hypoxemia is defined as a peripheral oxygen saturation of ≤90% registered with the monitoring system of our working station (Phillips IntelliVue and Massimo Rad-97) after inducing deep sedation while under endoscopy intervention.

  Time between Induction of deep sedation and end of procedure (endoscopy)

Secondary Outcomes (7)

• Duration of intervention

  Time between Induction of deep sedation and end of procedure (endoscopy)

• Duration of hypoxemia

  Time between Induction of deep sedation and end of procedure (endoscopy)

• Hypoxemic events

  Time between Induction of deep sedation and end of procedure (endoscopy)

• hypoxemia duration to procedure duration

  Time between Induction of deep sedation and end of procedure (endoscopy)

• Airway intervention

  Time between Induction of deep sedation and end of procedure (endoscopy)

Study Arms (2)

nasal continuous positive airway pressure

EXPERIMENTAL

nasal continuous positive airway pressure (3-10cmH20) administered with 6 l/O2 with the SuperNO2VA™ Et produced by Vyaire Medical, Inc.

Device: SuperNO2VA™ Et by Vyaire Medical, Inc.

nasal oxygen insufflation

ACTIVE COMPARATOR

nasal oxygen insufflation with 6 l/02 will be administered as control-group/standard intervention for endoscopy

Device: nasal oxygen cannula

Interventions

SuperNO2VA™ Et by Vyaire Medical, Inc. DEVICE

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

nasal continuous positive airway pressure

nasal oxygen cannula DEVICE

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

nasal oxygen insufflation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Age \< 18 years
• Pregnancy
• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine

Hamburg, 20246, Germany

Location

Related Publications (1)

• Hunerbein K, Sprenger C, Zollner C, de Heer J, von Wulffen M, Zimmermann K, Rosch T, Issleib M. Nasal Continuous Positive Airway Pressure to Reduce Hypoxia in Patients With Obesity Undergoing Sedated Upper Gastrointestinal Endoscopy: A Prospective Randomized Trial. Clin Gastroenterol Hepatol. 2026 Jan;24(1):113-120.e4. doi: 10.1016/j.cgh.2025.06.015. Epub 2025 Jul 1.

  PMID: 40609816 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Karlo R Huenerbein, Dr. med.

  Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomized single centre trial

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 13, 2023
• Study Start: November 1, 2023
• Primary Completion: May 30, 2024
• Study Completion: June 30, 2024
• Last Updated: December 9, 2024

Record last verified: 2024-12

Locations

DE (1)