Gynecologic Surgery, High-flow Nasal Cannula, Post-operative Pulmonary Complications
Conditions
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.
Interventions
DEVICEheated 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.
DEVICENasal cannula oxygen
Nasal cannula oxygen has become a routine part of postoperative treatment
Sponsors
Sichuan Cancer Hospital and Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Adverse events | 2 days after the surgery | Adverse events Associated with Oxygen Therapy |
Countries
China
Contacts
Primary ContactDengfeng Wang, M.D.
Outcome results
None listed