Clinical trial NCT06554678: THRIVE Improves Early Postoperative Atelectasis in Long-Time Non-Tracheal Intubation Anesthesia for Gastrointestinal Endoscopy: a Clinical Study
Official title: THRIVE Improves Early Postoperative Atelectasis in Long-Time Non-Tracheal Intubation Anesthesia for Gastrointestinal Endoscopy: a Clinical Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Early Postoperative Atelectasis
Lead sponsor: Northern Jiangsu People's Hospital
Sponsor class: OTHER
First posted: 2024-08-15
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Incidence of atelectasis
timeFrame: Early postoperative period
Secondary outcomes:
measure: Diaphragm movement
timeFrame: Before anesthesia induction (T1) and immediately after surgery (T2)
measure: Heart rate (HR)
timeFrame: Baseline，during surgery and arrived at PACU
measure: Pulse oxygen saturation (SpO2)
timeFrame: Baseline，during surgery and arrived at PACU
measure: Mean blood pressure (MBP)
timeFrame: Baseline，during surgery and arrived at PACU
measure: Patient satisfaction levels
timeFrame: After the patient is awake
measure: Endoscopist satisfaction levels
timeFrame: After the surgery
measure: Adverse Events (AEs) During Surgery and PACU
timeFrame: During surgery and PACU
measure: Adverse Events (AEs) Within 7 Days Post-Operatively
timeFrame: Within 7 days after surgery
measure: PACU Stay Duration
timeFrame: The time from entering PACU to improving Aldrete score ≥9
measure: Length of Hospital Stay
timeFrame: The time from admission to discharge
measure: Dosage of propofol
timeFrame: During surgery
measure: Dosage of remifentanil
timeFrame: During surgery
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital
state: Jiangsu
Study officials:
References: