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CPAP Treatment and Postoperative Outcomes in Patients With Rheumatic Valvular Heart Disease (CPAP)

Primary Purpose

Rheumatic Valvular Heart Disease, Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
continuous positive airway pressure
Sponsored by
Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatic Valvular Heart Disease focused on measuring Obstructive Sleep Apnea, heart valve replacement, CPAP treatment

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients aged 18-75 years.
  2. Patients with rheumatic valvular heart disease.
  3. Patients combined with obstructive sleep apnea (apnea-hypopnea index >=5/h).
  4. Received heart valve replacement surgery.
  5. The enrolled patients having received patients' informed consent.

Exclusion Criteria:

  1. History of stroke or clinical signs of peripheral or central nervous system disorders.
  2. History of Chronic obstructive pulmonary disease or asthma.
  3. Enrolment in another clinical study.

Sites / Locations

  • The First Affiliated Hospital of Nanjing Medical University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

continuous positive airway pressure

Arm Description

The CPAP treatment group received both baseline and CPAP treatment for 7 days preoperatively.

Outcomes

Primary Outcome Measures

apnea-hypopnea index (AHI)
The changes of apnea-hypopnea index pre- and post-operative were compared between CPAP and non-CPAP patients.
duration of ICU stay
Postoperative duration of ICU stay was compared between CPAP and non-CPAP patients.
length of mechanical ventilation
Postoperative length of mechanical ventilation was compared between CPAP and non-CPAP patients.

Secondary Outcome Measures

mean and lowest SPO2
The changes of mean and lowest SPO2 pre- and post-operative were compared between CPAP and non-CPAP patients
pacemaker use
Postoperative pacemaker use was compared between CPAP and non-CPAP patients.
complicated infection and reintubation
Postoperative complicated infection and reintubation were compared between CPAP and non-CPAP patients.

Full Information

First Posted
January 1, 2018
Last Updated
February 23, 2020
Sponsor
Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03398733
Brief Title
CPAP Treatment and Postoperative Outcomes in Patients With Rheumatic Valvular Heart Disease
Acronym
CPAP
Official Title
Preoperative CPAP Treatment on Perioperative Outcomes in Rheumatic Valvular Heart Disease Patients With OSA
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
January 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing Medical University

4. Oversight

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

5. Study Description

Brief Summary
The prevalence of OSA (Obstructive sleep apnea,OSA) is 2%-4% in general population and 16%-47% in surgical-heart failure patients. Our previous study found that OSA was associated with the increasing incidence of perioperative adverse events.The continuous positive airway pressure (CPAP), as the standard treatment for OSA, is extensively applied clinically. The previous study reported that postoperative AHI was reduced and SPO2 was increased by CPAP treatment. However, whether CPAP treatment can improve OSA postoperative and related adverse events or not in patients with rheumatic valvular heart diseases (RVHD) were not reported.The purpose of this study is to observe the effective of preoperative CPAP on postoperative sleep parameters and adverse events, such as AHI changes, duration of ICU stay and duration of mechanical ventilation.
Detailed Description
Between December 1, 2017 and June 30 2019, 200 patients with chronic heart failure caused by rheumatic valvular heart disease waiting for heart valve replacement in Department of Cardiovascular Surgery were screened for obstructive sleep apnea (OSA) by full-night polysomnography (PSG). Of them, 30 OSA patients were enrolled and randomly received CPAP treatment and non-CPAP treatment (15:15). The CPAP treatment group received both baseline and CPAP treatment. The full-night CPAP treatment was conducted from 21:00 pm to 6:00 am for 7 days preoperatively. The non-CPAP treatment group received baseline treatment. Preoperative Sleep parameters (AHI, mean and lowest SPO2) and clinical evaluations including NYHA class, electrocardiographic, echocardiographic, arterial blood gas analysis findings, baseline medication, and 6-minute walk test were recorded. Operation related parameters such as duration of operation, duration of cardiopulmonary bypass and bleeding volume were recorded. Postoperative adverse events such as duration of ICU stay, postoperative duration of mechanical ventilation, pacemaker use, complicated infection and reintubation are recorded. A PSG was re-examined before discharge from hospital. The changes of AHI, mean and lowest SPO2 between pre- and post-operative PSG parameters were calculated. The operation related parameters, postoperative adverse events and the changes of sleep parameters were compared between CPAP and non-CPAP patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatic Valvular Heart Disease, Obstructive Sleep Apnea
Keywords
Obstructive Sleep Apnea, heart valve replacement, CPAP treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A total of 200 patients with rheumatic valvular heart disease waiting for heart valve replacement were screened for obstructive sleep apnea (OSA). Of them, 30 OSA patients were enrolled and randomly received CPAP treatment and non-CPAP treatment (15:15 patients).The CPAP treatment group received both baseline and CPAP treatment for 7 days preoperatively. The non-CPAP treatment group only received baseline treatment.
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
continuous positive airway pressure
Arm Type
Other
Arm Description
The CPAP treatment group received both baseline and CPAP treatment for 7 days preoperatively.
Intervention Type
Device
Intervention Name(s)
continuous positive airway pressure
Intervention Description
The CPAP treatment group received both baseline and CPAP treatment for 7 days preoperatively. The non-CPAP treatment group only received baseline treatment.
Primary Outcome Measure Information:
Title
apnea-hypopnea index (AHI)
Description
The changes of apnea-hypopnea index pre- and post-operative were compared between CPAP and non-CPAP patients.
Time Frame
2 weeks,depends on length of hospital stay
Title
duration of ICU stay
Description
Postoperative duration of ICU stay was compared between CPAP and non-CPAP patients.
Time Frame
3 days, depends on the patient's recovery
Title
length of mechanical ventilation
Description
Postoperative length of mechanical ventilation was compared between CPAP and non-CPAP patients.
Time Frame
1 day, depends on the patient's recovery
Secondary Outcome Measure Information:
Title
mean and lowest SPO2
Description
The changes of mean and lowest SPO2 pre- and post-operative were compared between CPAP and non-CPAP patients
Time Frame
2 weeks,depends on length of hospital stay
Title
pacemaker use
Description
Postoperative pacemaker use was compared between CPAP and non-CPAP patients.
Time Frame
3 days, depends on the patient's recovery
Title
complicated infection and reintubation
Description
Postoperative complicated infection and reintubation were compared between CPAP and non-CPAP patients.
Time Frame
3 days, depends on the patient's recovery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged 18-75 years. Patients with rheumatic valvular heart disease. Patients combined with obstructive sleep apnea (apnea-hypopnea index >=5/h). Received heart valve replacement surgery. The enrolled patients having received patients' informed consent. Exclusion Criteria: History of stroke or clinical signs of peripheral or central nervous system disorders. History of Chronic obstructive pulmonary disease or asthma. Enrolment in another clinical study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ning Ding, MD, PhD
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
The First Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The individual participant data will not be shared. The informed consent will be ansigned before enrolled in the study and ensured to keep personal information confidential.
Citations:
PubMed Identifier
27448416
Citation
Ding N, Ni BQ, Wang H, Ding WX, Xue R, Lin W, Kai Z, Zhang SJ, Zhang XL. Obstructive Sleep Apnea Increases the Perioperative Risk of Cardiac Valve Replacement Surgery: A Prospective Single-Center Study. J Clin Sleep Med. 2016 Oct 15;12(10):1331-1337. doi: 10.5664/jcsm.6182.
Results Reference
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CPAP Treatment and Postoperative Outcomes in Patients With Rheumatic Valvular Heart Disease

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