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

University of Electronic Science and Technology of China (UESTC)

Status: Enrolling

Conditions: High-flow Nasal Cannula; Gynecologic Surgery; Post-operative Pulmonary Complications

Treatments: Device: Nasal cannula oxygen; Device: heated humidified high flow nasal cannula oxygen therapy, HFNC

Study type: Interventional

Funder types: Other

Identifiers

NCT05526534

HFNC202205.V1.1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

HFNC group

Experimental group

Description:

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.

Treatment:

Device: heated humidified high flow nasal cannula oxygen therapy, HFNC

Control group

Other group

Description:

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.

Treatment:

Device: Nasal cannula oxygen