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

Study Overview
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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.

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.

Official Title
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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

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

Intervention / Treatment
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* Device: heated humidified high flow nasal cannula oxygen therapy, HFNC
* Device: Nasal cannula oxygen


Participation Criteria
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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: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HFNC group<br>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. | Device: heated humidified high flow nasal cannula oxygen therapy, HFNC<br>* 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.<br>|
| Other: Control group<br>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. | Device: Nasal cannula oxygen<br>* Nasal cannula oxygen has become a routine part of postoperative treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pulmonary complication | 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. | 7 days after the surgery | 

Secondary Outcome Measures

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