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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06554678
Enrollment
150
Registered
2024-08-15
Start date
2024-02-18
Completion date
2025-03-31
Last updated
2025-03-14

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

Conditions

Early Postoperative Atelectasis

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.

Interventions

PROCEDURETransnasal humidified rapid insufflation ventilatory exchange(THRIVE)

Transnasal humidified rapid insufflation ventilatory exchange(THRIVE)

PROCEDUREconventional oxygen mask

conventional oxygen mask

Sponsors

Northern Jiangsu People's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of atelectasisEarly postoperative periodLung ultrasound examination was performed before anesthesia induction (T1) and immediately after surgery (T2), and patients' modified lung ultrasound score (LUSS) was recorded.

Secondary

MeasureTime frameDescription
Heart rate (HR)Baseline,during surgery and arrived at PACUThroughout the procedure, the heart rate (HR) was continuously monitored.
Pulse oxygen saturation (SpO2)Baseline,during surgery and arrived at PACUThroughout the procedure, the pulse oxygen saturation (SpO2) were continuously monitored.
Mean blood pressure (MBP)Baseline,during surgery and arrived at PACUThroughout the procedure, the mean blood pressure (MBP) was measured at 3-minute intervals.
Patient satisfaction levelsAfter the patient is awakeThe 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.
Endoscopist satisfaction levelsAfter the surgeryThe 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.
Diaphragm movementBefore anesthesia induction (T1) and immediately after surgery (T2)
Adverse Events (AEs) Within 7 Days Post-OperativelyWithin 7 days after surgeryFever; Cough and Sputum Production; Antibiotic Usage
PACU Stay DurationThe time from entering PACU to improving Aldrete score ≥9
Length of Hospital StayThe time from admission to discharge
Dosage of propofolDuring surgery
Dosage of remifentanilDuring surgery
Adverse Events (AEs) During Surgery and PACUDuring surgery and PACUradycardia; Hypertension; Hypotension; Hypoxemia; Aspiration and Regurgitation

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 11, 2026