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

• ClinicalTrials.gov Identifier: NCT03398733
• Recruitment Status: Completed
• First Posted: January 12, 2018
• Last Update Posted: February 25, 2020
• Sponsor: Nanjing Medical University
• Information provided by (Responsible Party): Ning Ding, Nanjing Medical University

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.

Condition or disease	Intervention/treatment	Phase
Rheumatic Valvular Heart Disease; Obstructive Sleep Apnea	Device: continuous positive airway pressure	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 32 participants
• Allocation: N/A
• 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.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Preoperative CPAP Treatment on Perioperative Outcomes in Rheumatic Valvular Heart Disease Patients With OSA
• Actual Study Start Date: December 1, 2017
• Actual Primary Completion Date: December 1, 2019
• Actual Study Completion Date: January 31, 2020

Arms and Interventions

Arm	Intervention/treatment
continuous positive airway pressure; The CPAP treatment group received both baseline and CPAP treatment for 7 days preoperatively.	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.

Outcome Measures

Primary Outcome Measures :

1. apnea-hypopnea index (AHI) [ Time Frame: 2 weeks,depends on length of hospital stay ]
   The changes of apnea-hypopnea index pre- and post-operative were compared between CPAP and non-CPAP patients.
2. duration of ICU stay [ Time Frame: 3 days, depends on the patient's recovery ]
   Postoperative duration of ICU stay was compared between CPAP and non-CPAP patients.
3. length of mechanical ventilation [ Time Frame: 1 day, depends on the patient's recovery ]
   Postoperative length of mechanical ventilation was compared between CPAP and non-CPAP patients.

Secondary Outcome Measures :

1. mean and lowest SPO2 [ Time Frame: 2 weeks,depends on length of hospital stay ]
   The changes of mean and lowest SPO2 pre- and post-operative were compared between CPAP and non-CPAP patients
2. pacemaker use [ Time Frame: 3 days, depends on the patient's recovery ]
   Postoperative pacemaker use was compared between CPAP and non-CPAP patients.
3. complicated infection and reintubation [ Time Frame: 3 days, depends on the patient's recovery ]
   Postoperative complicated infection and reintubation were compared between CPAP and non-CPAP patients.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

China, Jiangsu

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China, 210029

Sponsors and Collaborators

Nanjing Medical University

Investigators

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

More Information

Publications:

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.

• Responsible Party: Ning Ding, Principal Investigator, Nanjing Medical University
• ClinicalTrials.gov Identifier: NCT03398733
• Other Study ID Numbers: 2017-SR-040
• First Posted: January 12, 2018
• Last Update Posted: February 25, 2020
• Last Verified: February 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ning Ding, Nanjing Medical University:

Obstructive Sleep Apnea; heart valve replacement; CPAP treatment

Additional relevant MeSH terms:

Rheumatic Diseases; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Heart Diseases; Heart Valve Diseases; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Cardiovascular Diseases; Musculoskeletal Diseases; Connective Tissue Diseases