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Evaluation of the Safety and Efficacy of Nasal Pharyngeal Set-flexible (NaPS flex) in Maintaining Ventilation in Patients Undergoing Sedation for ERCP

Comparison of Nasal Pharyngeal Set-flexible (NaPS flex) and Traditional Nasal Cannula during ERCP Sedation: A Prospective Randomized Controlled Clinical Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120646
Enrollment
Unknown
Registered
2026-03-18
Start date
2024-11-26
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

Hypoxemia

Interventions

Sponsors

Wuxi Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.ASA classification I-III 2.BMI<=30 kg/m^2 3. Age: 18 years old to 80 years old 4. Sign the informed consent form

Exclusion criteria

Exclusion criteria: 1. No fasting or fluid restriction before the operation 2. Upper respiratory tract infection within 2 weeks 3. Nasal deformity, cranial brain trauma 4. Basal oxygen saturation <=90% 5. Patients with cardiac dysfunction (EF < 48%) or severe obstructive ventilation dysfunction

Design outcomes

Primary

MeasureTime frame
Incidence of hypoxemia(SpO2<=90%);Incidence of severe hypoxemia(SpO2<=85%);

Secondary

MeasureTime frame
Minimum oxygen saturation;Mean pulse oximetry;Anesthetic drug induction and total dosage;Hemodynamic parameters;End-tidal carbon dioxide;Adverse events;Manual interventions and frequency;Patient satisfaction scores;Endoscopist satisfaction score;Anesthesiologist Satisfaction Score;

Countries

China

Contacts

Public ContactXiao Liang

Wuxi Second People's Hospital

liangxiao_doctor@163.com+86 182 6227 8182

Outcome results

None listed

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