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Effect of nasal catheter or nasal mask oxygen administration on hypoxemia in patients undergoing endoscopic retrograde cholangiopancreatography under deep sedation: a prospective randomized controlled study

Effect of nasal catheter or nasal mask oxygen administration on hypoxemia in patients undergoing endoscopic retrograde cholangiopancreatography under deep sedation: a prospective randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093743
Enrollment
Unknown
Registered
2024-12-11
Start date
2024-12-12
Completion date
Unknown
Last updated
2024-12-16

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

Conditions

Biliary tract diseases such as bile duct stones, inflammatory stenosis, malignant tumors, postoperative stenosis or bile leakage

Interventions

Sponsors

ShangHai ChangHai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age>18 years old and<=70 years old; 2.BMI 18-30 kg/m^2; 3. ASA levels I-III; 4. The planned anesthesia method is MAC; 5. Patient consent, sign informed consent form

Exclusion criteria

Exclusion criteria: 1. Emergency surgeons; 2. Patients with moderate or above abnormal heart and lung function (such as severe arrhythmia, conduction block, heart failure, hypertrophic cardiomyopathy, dilated cardiomyopathy, pulmonary heart disease, severe valve disease, and respiratory failure); 3. Patients with severe liver and kidney dysfunction (liver enzymes>2 times normal, urea nitrogen>8.2 µ mol/L, creatinine>133 µ mol/L); 4. Use of anticoagulants or coagulation dysfunction (PT>17 s or APTT>47 s); 5. Patients with oral, nasal, and throat infections; 6. Individuals who are allergic to the anesthetics used; 7. Pregnant and lactating women; 8. Patients who are expected to undergo complex or prolonged procedures requiring general anesthesia with endotracheal intubation (pancreatic cyst puncture drainage, EUS-BD, EUS-PD, EUS-GE, etc.); 9. Currently participating in other clinical trials or using other clinical trial drugs within the first 3 months of enrollment.

Design outcomes

Primary

MeasureTime frame
Incidence of hypoxemia;

Secondary

MeasureTime frame
Incidence of other adverse reactions;Incidence of hypoxemia requiring NPA insertion, incidence of hypoxemia after NPA intervention, incidence of severe hypoxemia, and minimum oxygen saturation;The number and duration of endoscopic pauses caused by anesthesiologist intervention;Incidence of nasal discomfort symptoms;Satisfaction scores of patients, operating physicians and anesthesiologists;Incidence of gastrointestinal adverse reactions;

Countries

China

Contacts

Public ContactLi Bo

ShangHai ChangHai Hospital

ishilibo@163.com+86 21 31161853

Outcome results

None listed

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