Preoperative CPAP Treatment on Perioperative Outcomes in Rheumatic Valvular Heart Disease Patients With OSA

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



Sponsors


Source

Nanjing Medical University

Oversight Info

Has Dmc

Yes

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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.

Overall Status

Recruiting

Start Date

2017-12-01

Completion Date

2019-06-30

Primary Completion Date

2018-12-31

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

apnea-hypopnea index (AHI)
2 weeks,depends on length of hospital stay
duration of ICU stay
3 days, depends on the patient's recovery
length of mechanical ventilation
1 day, depends on the patient's recovery

Secondary Outcome

Measure

Time Frame

mean and lowest SPO2
2 weeks,depends on length of hospital stay
pacemaker use
3 days, depends on the patient's recovery
complicated infection and reintubation
3 days, depends on the patient's recovery

Enrollment

30

Conditions


Intervention

Intervention Type

Device

Intervention Name


Description

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

Arm Group Label

continuous positive airway pressure


Eligibility

Criteria

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.

Gender

All

Minimum Age

18 Years

Maximum Age

75 Years

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Ning Ding, MD, PhD
Study Chair
The First Affiliated Hospital with Nanjing Medical University

Overall Contact

Last Name

Hong Wang, MD, PhD

Phone

8602568236723

Email



Location

Facility

Status

Contact

The First Affiliated Hospital of Nanjing Medical University
Nanjing Jiangsu 210029 China
Recruiting
Last Name: Ning Ding, MD, PhD
Phone: 8602568136723

Location Countries

Country

China


Verification Date

2018-01-01

Lastchanged Date

2018-01-06

Firstreceived Date

2018-01-01

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

Nanjing Medical University

Investigator Full Name

Ning Ding

Investigator Title

Principal Investigator


Keywords


Has Expanded Access

No

Condition Browse


Number Of Arms

1

Arm Group

Arm Group Label

continuous positive airway pressure

Arm Group Type

Other

Description

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


Firstreceived Results Date

N/A

Reference

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.

PMID

27448416


Acronym

CPAP

Firstreceived Results Disposition Date

N/A

Study Design Info

Intervention Model

Single Group Assignment

Intervention 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.

Primary Purpose

Treatment

Masking

None (Open Label)


Study First Submitted

January 1, 2018

Study First Submitted Qc

January 6, 2018

Study First Posted

January 12, 2018

Last Update Submitted

January 6, 2018

Last Update Submitted Qc

January 6, 2018

Last Update Posted

January 12, 2018


ClinicalTrials.gov processed this data on January 12, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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