Clinical trial NCT05526534: A RCT on the Preventive Effect of HFNC on Postoperative Pulmonary Complications in Patients With Gynecologic Neoplasms
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gynecologic Surgery
High-flow Nasal Cannula
Post-operative Pulmonary Complications
Lead sponsor: Sichuan Cancer Hospital and Research Institute
Sponsor class: OTHER
First posted: 2022-09-02
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Postoperative pulmonary complication
timeFrame: 7 days after the surgery
Secondary outcomes:
measure: Total Hospitalization days
timeFrame: 7 days after the surgery
measure: Oxygen therapy
timeFrame: 2 days after the surgery
measure: Antibiotics
timeFrame: 7 days after the surgery
measure: Postoperative oxygenation
timeFrame: 2 days after the surgery
measure: Adverse events
timeFrame: 2 days after the surgery
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Cancer Hospital and Research Institute
state: Sichuan
Study officials:
affiliation: Sichuan Cancer Hospital and Research Institute
name: Dengfeng Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.