CPAP Treatment and Postoperative Outcomes in Patients With Rheumatic Valvular Heart Disease
Condition: Rheumatic Valvular Heart Disease; Obstructive Sleep Apnea
MeSH terms: Rheumatic Diseases; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Heart Diseases; Heart Valve Diseases
Study type: Interventional

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.
    

Intervention name(s): continuous positive airway pressure
Intervention type(s): Device
Intervention description(s): The CPAP treatment group received both baseline and CPAP treatment for 7 days preoperatively. The non-CPAP treatment group only received baseline treatment.
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
Keywords: Obstructive Sleep Apnea; heart valve replacement; CPAP treatment