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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03398733
Acronym
CPAP
Enrollment
32
Registered
2018-01-12
Start date
2017-12-01
Completion date
2020-01-31
Last updated
2020-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea, Rheumatic Valvular Heart Disease

Keywords

Obstructive Sleep Apnea, heart valve replacement, CPAP treatment

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.

Interventions

DEVICEcontinuous 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.

Sponsors

Nanjing Medical University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
duration of ICU stay3 days, depends on the patient's recoveryPostoperative duration of ICU stay was compared between CPAP and non-CPAP patients.
apnea-hypopnea index (AHI)2 weeks,depends on length of hospital stayThe changes of apnea-hypopnea index pre- and post-operative were compared between CPAP and non-CPAP patients.
length of mechanical ventilation1 day, depends on the patient's recoveryPostoperative length of mechanical ventilation was compared between CPAP and non-CPAP patients.

Secondary

MeasureTime frameDescription
mean and lowest SPO22 weeks,depends on length of hospital stayThe changes of mean and lowest SPO2 pre- and post-operative were compared between CPAP and non-CPAP patients
pacemaker use3 days, depends on the patient's recoveryPostoperative pacemaker use was compared between CPAP and non-CPAP patients.
complicated infection and reintubation3 days, depends on the patient's recoveryPostoperative complicated infection and reintubation were compared between CPAP and non-CPAP patients.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026