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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Early Postoperative Atelectasis
• Intervention / Treatment: Procedure: Transnasal humidified rapid insufflation ventilatory exchange（THRIVE）; Procedure: conventional oxygen mask

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Yangzhou, Jiangsu, China, 225000
      • Northern Jiangsu People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transnasal humidified rapid insufflation ventilatory exchange（THRIVE） group	Procedure: Transnasal humidified rapid insufflation ventilatory exchange（THRIVE）; Transnasal humidified rapid insufflation ventilatory exchange（THRIVE）
Active Comparator: conventional oxygen mask group	Procedure: conventional oxygen mask; conventional oxygen mask

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of atelectasis	Lung ultrasound examination was performed before anesthesia induction (T1) and immediately after surgery (T2), and patients' modified lung ultrasound score (LUSS) was recorded.	Early postoperative period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diaphragm movement		Before anesthesia induction (T1) and immediately after surgery (T2)
Heart rate (HR)	Throughout the procedure, the heart rate (HR) was continuously monitored.	Baseline，during surgery and arrived at PACU
Pulse oxygen saturation (SpO2)	Throughout the procedure, the pulse oxygen saturation (SpO2) were continuously monitored.	Baseline，during surgery and arrived at PACU
Mean blood pressure (MBP)	Throughout the procedure, the mean blood pressure (MBP) was measured at 3-minute intervals.	Baseline，during surgery and arrived at PACU
Patient satisfaction levels	The patients express their satisfaction with procedures on a numerical rating scale, ranging from 0 to 10, where 0 is the minimum and 10 is the maximum satisfaction level.	After the patient is awake
Endoscopist satisfaction levels	The Endoscopists express their satisfaction with procedures on a numerical rating scale, ranging from 0 to 10, where 0 is the minimum and 10 is the maximum satisfaction level.	After the surgery
Adverse Events (AEs) During Surgery and PACU	radycardia; Hypertension; Hypotension; Hypoxemia; Aspiration and Regurgitation	During surgery and PACU
Adverse Events (AEs) Within 7 Days Post-Operatively	Fever; Cough and Sputum Production; Antibiotic Usage	Within 7 days after surgery
PACU Stay Duration		The time from entering PACU to improving Aldrete score ≥9
Length of Hospital Stay		The time from admission to discharge
Dosage of propofol		During surgery
Dosage of remifentanil		During surgery

Collaborators and Investigators

• Sponsor: Northern Jiangsu People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: August 12, 2024
• First Submitted That Met QC Criteria: August 12, 2024
• First Posted (Actual): August 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Atelectasis
• Other Study ID Numbers: 2024ky033

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No