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

NCT03398733 | Completed DMC

• 1 other identifier: 2017-SR-040
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatic Valvular Heart Disease; Obstructive Sleep Apnea

Keywords

Obstructive Sleep Apnea; heart valve replacement; CPAP treatment

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• mean and lowest SPO2

  2 weeks,depends on length of hospital stay

• pacemaker use

  3 days, depends on the patient's recovery

• complicated infection and reintubation

  3 days, depends on the patient's recovery

Study Arms (1)

continuous positive airway pressure

OTHER

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

Device: continuous positive airway pressure

Interventions

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.

continuous positive airway pressure

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

Related Publications (2)

• 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.

  PMID: 27448416 BACKGROUND

• Su M, Lin W, Xu Q, Ni B, Zhang X, Zhang S, Ding N. Impact of 1-week preoperative auto-CPAP treatment on postoperative outcomes in patients undergoing heart valve replacement surgery: a prospective randomized controlled trial. Front Neurol. 2023 Jun 5;14:1152168. doi: 10.3389/fneur.2023.1152168. eCollection 2023.

  PMID: 37342775 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Ning Ding, MD, PhD

  The First Affiliated Hospital with Nanjing Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 1, 2018
• First Posted: January 12, 2018
• Study Start: December 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: January 31, 2020
• Last Updated: February 25, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)