Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06554678

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, 225000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Multiple polyps resection, ESD(Endoscopic Submucosal Dissection) , EMR(Endoscopic Mucosal Resection), enteroscopy and other gastrointestinal endoscopic diagnosis and treatment were performed
  • The duration of anesthesia is more than 30 minutes, that is, from induction to withdrawal of anesthesia
  • 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

  • ASA classification ≥ III;
  • History of previous lung or nasal surgery;
  • History of chronic obstructive pulmonary disease (COPD) or restrictive lung disease;
  • History of obstructive sleep apnea syndrome;
  • History of upper airway obstruction;
  • History of head and neck radiation therapy;
  • Significant nasal septum deviation;
  • Active infection (defined as a white blood cell count >10*10^9 or a body temperature >38°C);
  • Gastrointestinal perforation;
  • Combined use of other anesthetic methods or inhalation anesthetics outside of non-intubated intravenous anesthesia;
  • Concurrent other medical procedures besides the prescribed gastrointestinal endoscopic procedures, such as ERCP(Endoscopic Retrograde Cholangiopancreatography);
  • Severe communication disorders due to conditions like severe hearing impairment or dementia;
  • Disagreement with participation in the study.

Treatment and study plan

Transnasal humidified rapid insufflation ventilatory exchange(THRIVE)

Procedure

Transnasal humidified rapid insufflation ventilatory exchange(THRIVE)

conventional oxygen mask

Procedure

conventional oxygen mask

Primary outcomes

  1. Incidence of atelectasis

    Time frame: Early postoperative period

    Lung ultrasound examination was performed before anesthesia induction (T1) and immediately after surgery (T2), and patients' modified lung ultrasound score (LUSS) was recorded.

Secondary outcomes

  1. Diaphragm movement

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

  2. Heart rate (HR)

    Time frame: Baseline,during surgery and arrived at PACU

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

  3. Pulse oxygen saturation (SpO2)

    Time frame: Baseline,during surgery and arrived at PACU

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

  4. Mean blood pressure (MBP)

    Time frame: Baseline,during surgery and arrived at PACU

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

  5. Patient satisfaction levels

    Time frame: After the patient is awake

    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.

  6. Endoscopist satisfaction levels

    Time frame: After the surgery

    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.

  7. Adverse Events (AEs) During Surgery and PACU

    Time frame: During surgery and PACU

    radycardia; Hypertension; Hypotension; Hypoxemia; Aspiration and Regurgitation

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

    Time frame: Within 7 days after surgery

    Fever; Cough and Sputum Production; Antibiotic Usage

  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

Sponsors and collaborators

Lead sponsor

Northern Jiangsu People's Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 15, 2024
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.