NCT06085859

Anesthesia Endoscope Mask is Applied to Sedation Upper Gastrointestinal Endoscopic Diagnosis and Treatment

Anesthesia Endoscope Mask is Applied to Sedation Upper Gastrointestinal Endoscopic Diagnosis and Treatment: Multi-center, Prospective, Randomized Control, Open Clinical Research

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,208 (estimated)
• Sponsor: Sichuan Provincial People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

To investigate the efficacy and safety of new-type mask compared with nasal tube oxygen delivery in patients undergoing sedation of upper gastrointestinal endoscopy

Detailed description

This study aims to utilize a large sample, multicenter, prospective clinical trial using a new mask oxygen supply technology. If the study confirms that the new mask can improve the airway safety and effectiveness in patient examinations, while improving examination efficiency and reducing failure rates, it will provide safety assurance for the early diagnosis and treatment of upper gastrointestinal diseases in high-risk populations.

Conditions

• Hypoxemia

Interventions

Type	Name	Description
DEVICE	Routine nasal catheter group	The anaesthesia provider supplied oxygen via a nasal cannula at an oxygen flow rate of 8 Litres/minute supplied from an oxygen flowmeter as described in the guide
DEVICE	Mask group	The study team applied the mask with a head strap to ensure a proper seal,simultaneously ensuring the same oxygen flow rate as the control group

Timeline

• Start date: 2023-10-18
• Primary completion: 2023-12-01
• Completion: 2023-12-08
• First posted: 2023-10-17
• Last updated: 2023-11-18

Locations

5 sites across 1 country: China