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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
heated humidified high flow nasal cannula oxygen therapy, HFNC
Nasal cannula oxygen
Sponsored by
Sichuan Cancer Hospital and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gynecologic Surgery

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Sichuan Cancer Hospital and Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

HFNC group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Total Hospitalization days
Postoperative Hospitalization Days and ICU Stay Days
Oxygen therapy
The Need for Oxygen Therapy
Antibiotics
The use of antibiotics, including the type, usage, use time, etc.
Postoperative oxygenation
Improvement of Postoperative Oxygenation
Adverse events
Adverse events Associated with Oxygen Therapy

Full Information

First Posted
August 31, 2022
Last Updated
August 10, 2023
Sponsor
Sichuan Cancer Hospital and Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05526534
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sichuan Cancer Hospital and Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynecologic Surgery, High-flow Nasal Cannula, Post-operative Pulmonary Complications

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HFNC group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
heated humidified high flow nasal cannula oxygen therapy, HFNC
Intervention 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.
Intervention Type
Device
Intervention Name(s)
Nasal cannula oxygen
Intervention Description
Nasal cannula oxygen has become a routine part of postoperative treatment
Primary Outcome Measure Information:
Title
Postoperative pulmonary complication
Description
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.
Time Frame
7 days after the surgery
Secondary Outcome Measure Information:
Title
Total Hospitalization days
Description
Postoperative Hospitalization Days and ICU Stay Days
Time Frame
7 days after the surgery
Title
Oxygen therapy
Description
The Need for Oxygen Therapy
Time Frame
2 days after the surgery
Title
Antibiotics
Description
The use of antibiotics, including the type, usage, use time, etc.
Time Frame
7 days after the surgery
Title
Postoperative oxygenation
Description
Improvement of Postoperative Oxygenation
Time Frame
2 days after the surgery
Title
Adverse events
Description
Adverse events Associated with Oxygen Therapy
Time Frame
2 days after the surgery

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Patients With Gynecologic Neoplasms
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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: 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 Exclusion Criteria: Patients with lung metastasis of malignant tumor or primary lung malignant tumor; previous lung surgery or radiotherapy; the surgery involved segmental bowel resection.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dengfeng Wang, M.D.
Phone
+86 159 82222707
Email
wonderful_96@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dengfeng Wang, M.D.
Organizational Affiliation
Sichuan Cancer Hospital and Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sichuan Cancer Hospital and Research Institute
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dengfeng Wang, M.D.
Phone
+86 15982222707
Email
wonderful_96@163.com
First Name & Middle Initial & Last Name & Degree
Dengfeng Wang, M.D.

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD will be available to be shared 9 months after the study is published with a reasonable research plan.
IPD Sharing Time Frame
9 months after the study is published
IPD Sharing Access Criteria
Researchers who have a reasonable research plan
Citations:
PubMed Identifier
32615190
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.
Results Reference
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PubMed Identifier
32157356
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.
Results Reference
background
PubMed Identifier
27771739
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.
Results Reference
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A RCT on the Preventive Effect of HFNC on Postoperative Pulmonary Complications in Patients With Gynecologic Neoplasms

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