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

Not Applicable

Recruiting

• Conditions: High-flow Nasal Cannula; Post-operative Pulmonary Complications; Gynecologic Surgery
• Interventions: Device: Nasal cannula oxygen; Device: heated humidified high flow nasal cannula oxygen therapy, HFNC

• Registration Number: NCT05526534
• Lead Sponsor: Sichuan Cancer Hospital and Research Institute

Brief Summary

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.

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 Timeline

• Study First Submitted: 2022-08-31
• Study First Submitted QC: 2022-09-01
• Study First Posted: 2022-09-02
• Study Start: 2022-11-01
• Status Verified: 2024-11
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-23
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Nasal cannula oxygen	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.
HFNC group	heated humidified high flow nasal cannula oxygen therapy, HFNC	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.

Primary Outcome Measures

Name	Time	Method
Postoperative pulmonary complication	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 Outcome Measures

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

Trial Locations

Locations (1)

Sichuan Cancer Hospital and Research Institute; 🇨🇳 Chengdu, Sichuan, China