Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
FEMALE
ID05526534

Preventive Effect of Heated Humidified High Flow Nasal Cannula Oxygen Therapy on Postoperative Pulmonary Complications in Women With Gynecologic Tumors

Led by Sichuan Cancer Hospital and Research Institute · Updated on 2025-05-23

200

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of heated humidified high flow nasal cannula (HFNC) oxygen therapy compared to conventional nasal cannula oxygen therapy in patients with gynecologic tumors who are at high risk for post-operative pulmonary complications (PPC). The study focuses on women undergoing gynecological surgery and aims to measure the occurrence of PPC such as postoperative hypoxemia, atelectasis, and pneumonia. Secondary outcomes include improvements in postoperative oxygenation, antibiotic use, length of hospital stay, and any adverse events related to oxygen therapy. Participants are randomly assigned to one of two groups: the HFNC group receives heated humidified high flow nasal cannula oxygen therapy on the day of surgery and the first day after surgery, with oxygen saturation maintained between 92% and 95%. The control group receives conventional nasal cannula oxygen therapy during the same time frame, also maintaining oxygen saturation at 92% to 95%. Both groups have chest CT scans reviewed 36 to 48 hours after surgery. The HFNC device can provide oxygen concentrations ranging from 21% to 100% with heated and humidified gas at 37°C and a maximum flow of 70 liters per minute. During the study, participants will be monitored for postoperative pulmonary complications over seven days after surgery. Researchers will also assess total hospitalization days, oxygen therapy usage, antibiotic use, postoperative oxygenation, and any adverse events within two to seven days post-surgery. The study includes scheduled chest CT scans and continuous oxygen saturation monitoring to track participant outcomes. The study is sponsored by Sichuan Cancer Hospital and Research Institute and is expected to continue until the end of 2025.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 90Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients aged 18 to 90 years
  • Diagnosis of gynecologic neoplasms (benign or malignant) scheduled for surgery at the study center
  • Surgery expected to last 2 hours or longer
  • Must have a chest CT scan within 1 week before surgery
  • Must meet at least one of the following: respiratory risk score ≥45, BMI ≥30, moderate to severe asthma, moderate to severe COPD, or smoking history of 20 or more pack-years
Not Eligible

You will not qualify if you...

  • Presence of lung metastasis from malignant tumor or primary lung cancer
  • Previous lung surgery or lung radiotherapy
  • Surgery involving segmental bowel resection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - 2 days

Participants undergo gynecologic surgery and receive oxygen therapy via either heated humidified high flow nasal cannula or conventional nasal cannula on the day of surgery and the first day after surgery to maintain oxygen saturation between 92% and 95%.

1 surgery day visit and 1 post-operative day visit

Post-operative Follow-up

Duration - 7 days

Participants have chest CT reviewed 36 to 48 hours after surgery and are monitored for postoperative pulmonary complications, oxygenation, antibiotic use, and adverse events related to oxygen therapy up to 7 days after surgery.

1 follow-up visit within 7 days after surgery

Trial Site Locations

Total: 1 location

1

Sichuan Cancer Hospital and Research Institute

Chengdu, Sichuan, China, 610000

Actively Recruiting

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Research Team

D

Dengfeng Wang, M.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Noninvasive respiratory support in the hypoxaemic peri-operative/periprocedural patient: a joint ESA/ESICM guideline.

Marc Leone, Sharon Einav, Davide Chiumello...

https://pubmed.ncbi.nlm.nih.gov/32157356

Effect of early postextubation high-flow nasal cannula vs conventional oxygen therapy on hypoxaemia in patients after major abdominal surgery: a French multicentre randomised controlled trial (OPERA).

Emmanuel Futier, Catherine Paugam-Burtz, Thomas Godet...

https://pubmed.ncbi.nlm.nih.gov/27771739