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

March 11, 2025 updated by: Ju Gao, Northern Jiangsu People's Hospital
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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Early postoperative period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Diaphragm movement
Time Frame: Before anesthesia induction (T1) and immediately after surgery (T2)
Before anesthesia induction (T1) and immediately after surgery (T2)
Heart rate (HR)
Time Frame: Baseline，during surgery and arrived at PACU
Throughout the procedure, the heart rate (HR) was continuously monitored.
Baseline，during surgery and arrived at PACU
Pulse oxygen saturation (SpO2)
Time Frame: Baseline，during surgery and arrived at PACU
Throughout the procedure, the pulse oxygen saturation (SpO2) were continuously monitored.
Baseline，during surgery and arrived at PACU
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.
Baseline，during surgery and arrived at PACU
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.
After the patient is awake
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.
After the surgery
Adverse Events (AEs) During Surgery and PACU
Time Frame: During surgery and PACU
radycardia; Hypertension; Hypotension; Hypoxemia; Aspiration and Regurgitation
During surgery and PACU
Adverse Events (AEs) Within 7 Days Post-Operatively
Time Frame: Within 7 days after surgery
Fever; Cough and Sputum Production; Antibiotic Usage
Within 7 days after surgery
PACU Stay Duration
Time Frame: The time from entering PACU to improving Aldrete score ≥9
The time from entering PACU to improving Aldrete score ≥9
Length of Hospital Stay
Time Frame: The time from admission to discharge
The time from admission to discharge
Dosage of propofol
Time Frame: During surgery
During surgery
Dosage of remifentanil
Time Frame: During surgery
During surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northern Jiangsu People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 18, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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