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Bilevel Positive Airway Pressure for gastrointestinal endoscopy with sedation in patients at risk of hypoxaemia: a multicentre randomised controlled trial

Bilevel Positive Airway Pressure for gastrointestinal endoscopy with sedation in patients at risk of hypoxaemia: a multicentre randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120638
Enrollment
Unknown
Registered
2026-03-17
Start date
2026-03-20
Completion date
Unknown
Last updated
2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients at high hypoxaemia risk

Interventions

Group N:Nasal cannula oxygen therapy
Group B:Bilevel Positive Airway Pressure

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years; 2. Undergoing painless gastrointestinal endoscopy; 3. Individuals at risk of hypoxaemia, meeting any one of the following criteria: (1) Age > 60 years; (2) Frailty (Frail Scale score >= 3); (3) American Society of Anesthesiologists (ASA) physical status III–IV; (4) Obesity (BMI >= 30 kg/m²); (5) Sleep apnoea or STOP-Bang score >= 3; (6) Coexisting cardiac disease (left ventricular dysfunction with left ventricular ejection fraction <= 45%, ischaemic heart disease, chronic atrial fibrillation, cardiogenic pulmonary oedema, hypertension); (7) Coexisting respiratory disease (COPD, emphysema, bronchiectasis, asthma, pleural effusion, pulmonary interstitial fibrosis).

Exclusion criteria

Exclusion criteria: Patients meeting any of the following criteria will be excluded from the study: 1. Patients with a tracheostomy; 2. Pneumothorax, mediastinal emphysema; cerebrospinal fluid leakage, craniocerebral trauma, or intracranial pneumatosis; 3. Active epistaxis or uncontrolled upper gastrointestinal bleeding; 4. Hepatic or renal dysfunction; 5. Massive vocal cord polyps, acute pharyngitis, tonsillitis, or acute exacerbation of asthma; 6. Patient non-compliance or known allergy to propofol or any component of its emulsion; 7. Participation in another clinical study within the past 3 months.

Design outcomes

Primary

MeasureTime frame
Incidence of intraoperative hypoxaemia;

Secondary

MeasureTime frame
Number of hypoxaemic episodes;Time from completion of induction (MOAA/S = 1) to SpO? < 75%;Duration of hypoxaemia;Time from completion of induction (MOAA/S = 1) to SpO? < 90%;

Countries

China

Contacts

Public ContactNa Xing

The First Affiliated Hospital of Zhengzhou University

fccxingn@zzu.edu.cn+86 139 4909 5172

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 3, 2026