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Completed

NCT Number: NCT03398733

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

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.

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Key information

Conditions

Rheumatic Valvular Heart Disease Apnea Dyssomnias Nervous System Diseases Obstructive Sleep Apnea Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 18-75 years.
  • Patients with rheumatic valvular heart disease.
  • Patients combined with obstructive sleep apnea (apnea-hypopnea index >=5/h).
  • Received heart valve replacement surgery.
  • The enrolled patients having received patients' informed consent.

Exclusion criteria

  • History of stroke or clinical signs of peripheral or central nervous system disorders.
  • History of Chronic obstructive pulmonary disease or asthma.
  • Enrolment in another clinical study.

Treatment and study plan

Continuous Positive Airway Pressure

Device

The CPAP treatment group received both baseline and CPAP treatment for 7 days preoperatively. The non-CPAP treatment group only received baseline treatment.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Registry information

Official study title

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

Acronym: CPAP

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jan 12, 2018
Registry last updated
Feb 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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