THRIVE Improves Early Postoperative Atelectasis in Long-Time Non-Tracheal Intubation Anesthesia for Gastrointestinal Endoscopy: a Clinical Study

NCT ID: NCT06554678

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-18
• Study Completion Date: 2025-03-31

Brief Summary

This study aims to explore the clinical effect of THRIVE in improving early postoperative atelectasis in patients undergoing long-term non-intubated anesthesia gastrointestinal endoscopy.

Conditions

Early Postoperative Atelectasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Transnasal humidified rapid insufflation ventilatory exchange（THRIVE） group

Group Type: EXPERIMENTAL

Transnasal humidified rapid insufflation ventilatory exchange（THRIVE）

Intervention Type: PROCEDURE

Transnasal humidified rapid insufflation ventilatory exchange（THRIVE）

conventional oxygen mask group

Group Type: ACTIVE_COMPARATOR

conventional oxygen mask

Intervention Type: PROCEDURE

conventional oxygen mask

Interventions

Transnasal humidified rapid insufflation ventilatory exchange（THRIVE）

Transnasal humidified rapid insufflation ventilatory exchange（THRIVE）

Intervention Type: PROCEDURE

conventional oxygen mask

conventional oxygen mask

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Multiple polyps resection, ESD(Endoscopic Submucosal Dissection) , EMR(Endoscopic Mucosal Resection), enteroscopy and other gastrointestinal endoscopic diagnosis and treatment were performed

2. The duration of anesthesia is more than 30 minutes, that is, from induction to withdrawal of anesthesia

3. ASA(American Society of Anesthesiologists) ≤ II 4.18kg/m2<BMI<30 kg/m2

5.Informed consent, voluntary participation in the experiment, and signed by the subject informed consent

Exclusion Criteria

1. ASA classification ≥ III;

2. History of previous lung or nasal surgery;

3. History of chronic obstructive pulmonary disease (COPD) or restrictive lung disease;

4. History of obstructive sleep apnea syndrome;

5. History of upper airway obstruction;

6. History of head and neck radiation therapy;

7. Significant nasal septum deviation;

8. Active infection (defined as a white blood cell count >10*10^9 or a body temperature >38°C);

9. Gastrointestinal perforation;

10. Combined use of other anesthetic methods or inhalation anesthetics outside of non-intubated intravenous anesthesia;

11. Concurrent other medical procedures besides the prescribed gastrointestinal endoscopic procedures, such as ERCP(Endoscopic Retrograde Cholangiopancreatography);

12. Severe communication disorders due to conditions like severe hearing impairment or dementia;

13. Disagreement with participation in the study.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northern Jiangsu People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ju Gao

Study Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, China

Countries

China

Other Identifiers

2024ky033

Identifier Type: -

Identifier Source: org_study_id