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

Obstructive Sleep Apnea Clinical Trial

— CPAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03398733
• Other study ID #: 2017-SR-040
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: January 31, 2020

Study information

• Verified date: February 2020
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 31, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Diseases
• Heart Valve Diseases
• Obstructive Sleep Apnea
• Rheumatic Diseases
• Rheumatic Valvular Heart Disease
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• continuous positive airway pressure
The CPAP treatment group received both baseline and CPAP treatment for 7 days preoperatively. The non-CPAP treatment group only received baseline treatment.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	apnea-hypopnea index (AHI)	The changes of apnea-hypopnea index pre- and post-operative were compared between CPAP and non-CPAP patients.	2 weeks,depends on length of hospital stay
Primary	duration of ICU stay	Postoperative duration of ICU stay was compared between CPAP and non-CPAP patients.	3 days, depends on the patient's recovery
Primary	length of mechanical ventilation	Postoperative length of mechanical ventilation was compared between CPAP and non-CPAP patients.	1 day, depends on the patient's recovery
Secondary	mean and lowest SPO2	The changes of mean and lowest SPO2 pre- and post-operative were compared between CPAP and non-CPAP patients	2 weeks,depends on length of hospital stay
Secondary	pacemaker use	Postoperative pacemaker use was compared between CPAP and non-CPAP patients.	3 days, depends on the patient's recovery
Secondary	complicated infection and reintubation	Postoperative complicated infection and reintubation were compared between CPAP and non-CPAP patients.	3 days, depends on the patient's recovery