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NCT Number: NCT05526534

A RCT on the Preventive Effect of HFNC 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.

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Key information

Age range

18 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sichuan Cancer Hospital and Research Institute

Chengdu, Sichuan, 610000, China

Location status: Recruiting

Location contact

Dengfeng Wang, M.D.

CONTACT

[email protected]

+86 15982222707

Dengfeng Wang, M.D.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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:
  • Assess respiratory risk in surgical patients in Catalonia (ARRSPC) ≥45 points;
  • BMI≥30;
  • Moderate to severe asthma;
  • Moderate to severe chronic obstructive pulmonary disease (COPD);
  • Smoking history ≥20 packs/year

Exclusion criteria

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

Treatment and study plan

heated humidified high flow nasal cannula oxygen therapy, HFNC

Device

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.

Nasal cannula oxygen

Device

Nasal cannula oxygen has become a routine part of postoperative treatment

Primary outcomes

  1. 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.

Secondary outcomes

  1. Total Hospitalization days

    Time frame: 7 days after the surgery

    Postoperative Hospitalization Days and ICU Stay Days

  2. Oxygen therapy

    Time frame: 2 days after the surgery

    The Need for Oxygen Therapy

  3. Antibiotics

    Time frame: 7 days after the surgery

    The use of antibiotics, including the type, usage, use time, etc.

  4. Postoperative oxygenation

    Time frame: 2 days after the surgery

    Improvement of Postoperative Oxygenation

  5. Adverse events

    Time frame: 2 days after the surgery

    Adverse events Associated with Oxygen Therapy

Study contacts

Contact information is provided by the study sponsor or research team.

Dengfeng Wang, M.D.

CONTACT

[email protected]

+86 159 82222707

Sponsors and collaborators

Lead sponsor

Sichuan Cancer Hospital and Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 2, 2022
Registry last updated
May 23, 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.

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