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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2025-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Gynecologic Surgery High-flow Nasal Cannula Post-operative Pulmonary Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

heated humidified high flow nasal cannula oxygen therapy, HFNC

Intervention Type 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.

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.

Group Type OTHER

Nasal cannula oxygen

Intervention Type DEVICE

Nasal cannula oxygen has become a routine part of postoperative treatment

Interventions

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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.

Intervention Type DEVICE

Nasal cannula oxygen

Nasal cannula oxygen has become a routine part of postoperative treatment

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No