Gynecologic Surgery Clinical Trial
Official title:
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
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 90 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Sichuan Cancer Hospital and Research Institute | Chengdu | Sichuan |
Lead Sponsor | Collaborator |
---|---|
Sichuan Cancer Hospital and Research Institute |
China,
Chaudhuri D, Granton D, Wang DX, Burns KEA, Helviz Y, Einav S, Trivedi V, Mauri T, Ricard JD, Mancebo J, Frat JP, Jog S, Hernandez G, Maggiore SM, Mbuagbaw L, Hodgson CL, Jaber S, Goligher EC, Brochard L, Rochwerg B. High-Flow Nasal Cannula in the Immediate Postoperative Period: A Systematic Review and Meta-analysis. Chest. 2020 Nov;158(5):1934-1946. doi: 10.1016/j.chest.2020.06.038. Epub 2020 Jun 29. — View Citation
Futier E, Paugam-Burtz C, Godet T, Khoy-Ear L, Rozencwajg S, Delay JM, Verzilli D, Dupuis J, Chanques G, Bazin JE, Constantin JM, Pereira B, Jaber S; OPERA study investigators. Effect of early postextubation high-flow nasal cannula vs conventional oxygen therapy on hypoxaemia in patients after major abdominal surgery: a French multicentre randomised controlled trial (OPERA). Intensive Care Med. 2016 Dec;42(12):1888-1898. doi: 10.1007/s00134-016-4594-y. Epub 2016 Oct 22. — View Citation
Leone M, Einav S, Chiumello D, Constantin JM, De Robertis E, De Abreu MG, Gregoretti C, Jaber S, Maggiore SM, Pelosi P, Sorbello M, Afshari A; Guideline contributors. Noninvasive respiratory support in the hypoxaemic peri-operative/periprocedural patient: a joint ESA/ESICM guideline. Intensive Care Med. 2020 Apr;46(4):697-713. doi: 10.1007/s00134-020-05948-0. Epub 2020 Mar 10. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Total Hospitalization days | Postoperative Hospitalization Days and ICU Stay Days | 7 days after the surgery | |
Secondary | Oxygen therapy | The Need for Oxygen Therapy | 2 days after the surgery | |
Secondary | Antibiotics | The use of antibiotics, including the type, usage, use time, etc. | 7 days after the surgery | |
Secondary | Postoperative oxygenation | Improvement of Postoperative Oxygenation | 2 days after the surgery | |
Secondary | Adverse events | Adverse events Associated with Oxygen Therapy | 2 days after the surgery |
Status | Clinical Trial | Phase | |
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