A RCT on the Preventive Effect of HFNC on Postoperative Pulmonary Complications in Patients With Gynecologic Neoplasms

May 20, 2025 updated by: Dengfeng Wang, Sichuan Cancer Hospital and Research Institute

A Randomized Controlled Trial on the Preventive Effect of Heated Humidified High Flow Nasal Cannula Oxygen Therapy on Postoperative Pulmonary Complications in Patients With Gynecologic Neoplasms

Patients at high risk of post-operative pulmonary complications (PPC) will be screened out from gynecological tumor patients undergoing surgical treatment, and randomly assigned into the HFNC group and control group, which uses conventional nasal cannula oxygen therapy. The primary outcome is the incidence of PPC, including postoperative hypoxemia, atelectasis, pneumonia, etc. Secondary outcomes are the improvement of postoperative oxygenation, antibiotic use, length of hospital stay, adverse events related to oxygen therapy, etc.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
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.

Detailed Description

This randomized con aims to enroll patients at high risk of developing post-operative pulmonary complications after gynecological surgery, the eligible patients will be randomly assigned to receive oxygen therapy via high-flow nasal cannula or conventional nasal cannula. The study primary outcome is the incidence of post-operative pulmonary complications, including postoperative hypoxemia, atelectasis, pneumonia, etc. Secondary outcomes are the improvement of postoperative oxygenation, antibiotic use, length of hospital stay, adverse events related to oxygen therapy, etc.

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.
200

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Recruiting
        • Sichuan Cancer Hospital and Research Institute
        • Contact:
        • Principal Investigator:
          • Dengfeng Wang, M.D.

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

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with gynecologic Neoplasms, including benign gynecologic tumors and malignant gynecologic tumors, who are 18 to 90 years old and are scheduled for surgical treatment in our center shall receive plain chest CT scan within 1 week before surgery, and the estimated surgical time shall be ≥2 hours, and at least one of the following conditions shall be met:

    1. Assess respiratory risk in surgical patients in Catalonia (ARRSPC) ≥45 points;
    2. BMI≥30;
    3. Moderate to severe asthma;
    4. Moderate to severe chronic obstructive pulmonary disease (COPD);
    5. Smoking history ≥20 packs/year

Exclusion Criteria:

  1. Patients with lung metastasis of malignant tumor or primary lung malignant tumor;
  2. previous lung surgery or radiotherapy;
  3. the surgery involved segmental bowel resection.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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: HFNC group
HFNC group was given heated humidified high flow nasal cannula oxygen therapy on the day of surgery and the first day after surgery to maintain oxygen saturation at 92% ~ 95%.Chest CT was reviewed 36-48 hours after surgery.
Device: heated humidified high flow nasal cannula oxygen therapy, HFNC
HFNC can accurately provide 21% ~ 100% oxygen concentration through air oxygen mixer. And through the heating and humidification device to provide 37℃, relative humidity of 100% gas, the maximum flow of 70L/min.
Other: Control group
The control group was given conventional nasal catheter oxygen inhalation on the day of surgery and the first day after surgery, and oxygen flow was adjusted to maintain oxygen saturation at 92% ~ 95%.Chest CT was reviewed 36-48 hours after surgery.
Device: Nasal cannula oxygen
Nasal cannula oxygen has become a routine part of postoperative treatment

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
Postoperative pulmonary complication
Time Frame: 7 days after the surgery
The primary outcome measures were the incidence of PPC in the treatment group and the control group, including the incidence of postoperative hypoxemia, atelectasis, pneumonia, etc.
7 days after the surgery

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
Total Hospitalization days
Time Frame: 7 days after the surgery
Postoperative Hospitalization Days and ICU Stay Days
7 days after the surgery
Oxygen therapy
Time Frame: 2 days after the surgery
The Need for Oxygen Therapy
2 days after the surgery
Antibiotics
Time Frame: 7 days after the surgery
The use of antibiotics, including the type, usage, use time, etc.
7 days after the surgery
Postoperative oxygenation
Time Frame: 2 days after the surgery
Improvement of Postoperative Oxygenation
2 days after the surgery
Adverse events
Time Frame: 2 days after the surgery
Adverse events Associated with Oxygen Therapy
2 days after the 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.
Sichuan Cancer Hospital and Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dengfeng Wang, M.D., Sichuan Cancer Hospital and Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
November 1, 2022

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.
December 31, 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.
December 31, 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 31, 2022

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.
September 1, 2022

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.
September 2, 2022

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.
May 23, 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.
May 20, 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.
November 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.
  • HFNC202205.V1.1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD will be available to be shared 9 months after the study is published with a reasonable research plan.

IPD Sharing Time Frame

9 months after the study is published

IPD Sharing Access Criteria

Researchers who have a reasonable research plan

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

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.

Yes

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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