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Trial Title:
A RCT on the Preventive Effect of HFNC on Postoperative Pulmonary Complications in Patients With Gynecologic Neoplasms
NCT ID:
NCT05526534
Condition:
Gynecologic Surgery
High-flow Nasal Cannula
Post-operative Pulmonary Complications
Conditions: Official terms:
Neoplasms
Genital Neoplasms, Female
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
heated humidified high flow nasal cannula oxygen therapy, HFNC
Description:
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.
Arm group label:
HFNC group
Intervention type:
Device
Intervention name:
Nasal cannula oxygen
Description:
Nasal cannula oxygen has become a routine part of postoperative treatment
Arm group label:
Control group
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Gender based:
Yes
Gender description:
Patients With Gynecologic Neoplasms
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sichuan Cancer Hospital and Research Institute
Address:
City:
Chengdu
Zip:
610000
Country:
China
Status:
Recruiting
Contact:
Last name:
Dengfeng Wang, M.D.
Phone:
+86 15982222707
Email:
wonderful_96@163.com
Investigator:
Last name:
Dengfeng Wang, M.D.
Email:
Principal Investigator
Start date:
November 1, 2022
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Sichuan Cancer Hospital and Research Institute
Agency class:
Other
Source:
Sichuan Cancer Hospital and Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05526534
