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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05526534
• Other study ID #: HFNC202205.V1.1
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: Sichuan Cancer Hospital and Research Institute
• Contact: Dengfeng Wang, M.D.
• Phone: +86 159 82222707
• Email: wonderful_96[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Genital Neoplasms, Female
• Gynecologic Surgery
• High-flow Nasal Cannula
• Neoplasms
• Post-operative Pulmonary Complications

Intervention

Device:
• heated 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.
• Nasal cannula oxygen
Nasal cannula oxygen has become a routine part of postoperative treatment

Locations

Country	Name	City	State
China	Sichuan Cancer Hospital and Research Institute	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan Cancer Hospital and Research Institute

Country where clinical trial is conducted

China, 

References & 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. — 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

Outcome

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