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

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

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea; Rheumatic Valvular Heart Disease
• Intervention / Treatment: Device: continuous positive airway pressure

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • The First Affiliated Hospital of Nanjing Medical University

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
pacemaker use	Postoperative pacemaker use was compared between CPAP and non-CPAP patients.	3 days, depends on the patient's recovery
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

Collaborators and Investigators

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

Publications and helpful links

General 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. doi: 10.5664/jcsm.6182.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: January 1, 2018
• First Submitted That Met QC Criteria: January 6, 2018
• First Posted (Actual): January 12, 2018

Study Record Updates

• Last Update Posted (Actual): February 25, 2020
• Last Update Submitted That Met QC Criteria: February 23, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Obstructive Sleep Apnea; CPAP treatment; heart valve replacement
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Musculoskeletal Diseases; Connective Tissue Diseases; Heart Diseases; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Rheumatic Diseases; Heart Valve Diseases
• Other Study ID Numbers: 2017-SR-040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No