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

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

200

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

Sichuan Cancer Hospital and Research Institute

Investigators

  • 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)

November 1, 2022

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

August 31, 2022

First Submitted That Met QC Criteria

September 1, 2022

First Posted (Actual)

September 2, 2022

Study Record Updates

Last Update Posted (Actual)

May 23, 2025

Last Update Submitted That Met QC Criteria

May 20, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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