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

NCT05526534 | Recruiting

• 1 other identifier: HFNC202205.V1.1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecologic Surgery; High-flow Nasal Cannula; Post-operative Pulmonary Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Total Hospitalization days

  7 days after the surgery

• Oxygen therapy

  2 days after the surgery

• Antibiotics

  7 days after the surgery

• Postoperative oxygenation

  2 days after the surgery

• Adverse events

  2 days after the surgery

Study Arms (2)

HFNC group

EXPERIMENTAL

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

Control group

OTHER

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

Interventions

heated humidified high flow nasal cannula oxygen therapy, HFNC DEVICE

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.

HFNC group

Nasal cannula oxygen DEVICE

Nasal cannula oxygen has become a routine part of postoperative treatment

Control group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Gender Eligibility Details: Patients With Gynecologic Neoplasms
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with lung metastasis of malignant tumor or primary lung malignant tumor;
• previous lung surgery or radiotherapy;
• the surgery involved segmental bowel resection.

Sponsors & Collaborators

• Sichuan Cancer Hospital and Research Institute: lead

Study Sites (1)

Sichuan Cancer Hospital and Research Institute

Chengdu, Sichuan, 610000, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 32615190 BACKGROUND

• 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.

  PMID: 32157356 BACKGROUND

• 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.

  PMID: 27771739 BACKGROUND

Study Officials

• Dengfeng Wang, M.D.

  Sichuan Cancer Hospital and Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dengfeng Wang, M.D.

CONTACT

+86 159 82222707; wonderful_96@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: August 31, 2022
• First Posted: September 2, 2022
• Study Start: November 1, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 23, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 9 months after the study is published
• Access Criteria: Researchers who have a reasonable research plan

Locations

CN (1)