Skip to content

Bilevel positive airway pressure ventilation for gastroscopy with sedation in patients at risk of hypoxemia

Bilevel positive airway pressure ventilation for gastroscopy with sedation in patients at risk of hypoxemia : A prospective randomized clinical study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084596
Enrollment
Unknown
Registered
2024-05-21
Start date
2024-06-01
Completion date
Unknown
Last updated
2025-02-10

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

Conditions

hypoxemia

Interventions

nasal cannula group:nasal cannula for oxygen

Sponsors

Department of Anesthesiology, Pain and Perioperative Medicine, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, People's Republic of China.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years old. 2. Undergoing painless gastroscopy. 3. Population at risk of hypoxemia: meeting any of the following criteria: (1) Age > 60 years old. (2) Frailty (Frail Scale score >= 3). (3) ASA Grade III-IV. (4) Body Mass Index (BMI) >= 30 kg/m^2. (5) History of respiratory sleep apnea or STOP-Bang score >= 3 score. (6) Concurrent heart diseases (left ventricular dysfunction with ejection fraction <= 45%,combined heart, ischemic heart disease, chronic atrial fibrillation, cardiogenic pulmonary edema, hypertension). (7) Concurrent respiratory system diseases (COPD, emphysema, bronchiectasis, asthma, pleural effusion, pulmonary interstitial fibrosis). (8) Diabetes.

Exclusion criteria

Exclusion criteria: 1. Patients with tracheostomy. 2. Patients with conditions such as pneumothorax, mediastinal emphysema, cerebrospinal fluid leakage, cranial trauma, intracranial or extracranial trauma, or intracranial gas accumulation who are not suitable for BiPAP ventilation. 3. Active bleeding or upper gastrointestinal bleeding that has not been effectively controlled. 4. Abnormal liver or kidney function. 5. Patients with large vocal cord polyps, acute pharyngitis, tonsillitis, or acute asthma exacerbations. 6. Patients who are uncooperative or allergic to propofol or emulsifiers. 7. Participation in other clinical studies in the past 3 months. 8. Baseline pulse oximetry saturation <95%.

Design outcomes

Primary

MeasureTime frame
Incidence of hypoxemia;Adverse events related to intervention measures;

Secondary

MeasureTime frame
Duration of hypoxemia;Number of occurrences of hypoxemia;Total dose of propofol;Surgical duration;Number of gastroscopy intubations;Duration of sedation;Duration of recovery ;Postoperative satisfaction scores for patients, anesthesiologists, and endoscopists;

Countries

China

Contacts

Public ContactLi Huixin

The First Affiliated Hospital of Zhengzhou University

lihuixin0321@163.com+86 150 3815 5760

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026