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Active, not recruitingNCT06554678Updated Mar 14, 2025

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

An interventional study of Transnasal humidified rapid insufflation ventilatory exchange（THRIVE） and conventional oxygen mask in Early Postoperative Atelectasis, sponsored by Northern Jiangsu People's Hospital. Active, not recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2025-03-14.

Sponsored by Northern Jiangsu People's Hospital · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 7 months ago, but the record still lists the study as active, not recruiting.
  • Registered 5 months after the study started (first participant enrolled Feb 2024, registered Aug 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Early Postoperative Atelectasis

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03

In context

Pulmonary Atelectasis

301 studies on the registry are indexed under Pulmonary Atelectasis; 80 are open to participants now.

This study's planned enrollment of 150 is above the median of 61 across 222 interventional studies indexed under Pulmonary Atelectasis.

Browse Pulmonary Atelectasis studies →

Lead sponsor

Northern Jiangsu People's Hospital is the lead sponsor of 60 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Transnasal humidified rapid insufflation ventilatory exchange（THRIVE） group

    Procedure: Transnasal humidified rapid insufflation ventilatory exchange（THRIVE）

  • Active comparator
    conventional oxygen mask group

    Procedure: conventional oxygen mask

Interventions

  • ProcedureTransnasal humidified rapid insufflation ventilatory exchange（THRIVE）

    Transnasal humidified rapid insufflation ventilatory exchange（THRIVE）

  • Procedureconventional oxygen mask

    conventional oxygen mask

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Early postoperative period

Secondary outcomes

  1. Diaphragm movement

    Time frame: Before anesthesia induction (T1) and immediately after surgery (T2)

  2. Heart rate (HR)

    Throughout the procedure, the heart rate (HR) was continuously monitored.

    Time frame: Baseline，during surgery and arrived at PACU

  3. Pulse oxygen saturation (SpO2)

    Throughout the procedure, the pulse oxygen saturation (SpO2) were continuously monitored.

    Time frame: Baseline，during surgery and arrived at PACU

  4. Mean blood pressure (MBP)

    Throughout the procedure, the mean blood pressure (MBP) was measured at 3-minute intervals.

    Time frame: Baseline，during surgery and arrived at PACU

  5. 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.

    Time frame: After the patient is awake

  6. 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.

    Time frame: After the surgery

  7. Adverse Events (AEs) During Surgery and PACU

    radycardia; Hypertension; Hypotension; Hypoxemia; Aspiration and Regurgitation

    Time frame: During surgery and PACU

  8. Adverse Events (AEs) Within 7 Days Post-Operatively

    Fever; Cough and Sputum Production; Antibiotic Usage

    Time frame: Within 7 days after surgery

  9. PACU Stay Duration

    Time frame: The time from entering PACU to improving Aldrete score ≥9

  10. Length of Hospital Stay

    Time frame: The time from admission to discharge

  11. Dosage of propofol

    Time frame: During surgery

  12. Dosage of remifentanil

    Time frame: During surgery

07

Study locations

1 site
  • Northern Jiangsu People's Hospital
    Yangzhou, Jiangsu 225000, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06554678
Lead sponsor
Northern Jiangsu People's Hospital
Responsible party
Ju Gao (Study Director, Northern Jiangsu People's Hospital) — Principal investigator
First posted
Aug 15, 2024
Start date
Feb 18, 2024
Primary completion
Mar 2025 (estimated)
Completion
Mar 2025 (estimated)
Last update
Mar 14, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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