Rheumatic Valvular Heart DiseaseCPAPNCT03398733
CPAP Treatment and Postoperative Outcomes in Patients With Rheumatic Valvular Heart Disease
A study testing continuous positive airway pressure in people with Rheumatic Valvular Heart Disease and Obstructive Sleep Apnea, run by Nanjing Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatic Valvular Heart Disease, Obstructive Sleep Apnea
- What is being tested?
- continuous positive airway pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2017to 31 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
About this study
Official title: 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.
Read the 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.
- Being tested
- continuous positive airway pressure
- Keywords
- Obstructive Sleep Apnea, heart valve replacement, CPAP treatment
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous positive airway pressureDevice
The CPAP treatment group received both baseline and CPAP treatment for 7 days preoperatively. The non-CPAP treatment group only received baseline treatment.
| Study group | Role | What they receive |
|---|---|---|
| continuous positive airway pressure | Other | The CPAP treatment group received both baseline and CPAP treatment for 7 days preoperatively. Receives: Device: continuous positive airway pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
apnea-hypopnea index (AHI)
The changes of apnea-hypopnea index pre- and post-operative were compared between CPAP and non-CPAP patients.
Measured: 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.
Measured: 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.
Measured: 1 day, depends on the patient's recovery
Secondary outcomes (3)
mean and lowest SPO2
The changes of mean and lowest SPO2 pre- and post-operative were compared between CPAP and non-CPAP patients
Measured: 2 weeks,depends on length of hospital stay
pacemaker use
Postoperative pacemaker use was compared between CPAP and non-CPAP patients.
Measured: 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.
Measured: 3 days, depends on the patient's recovery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start1 Dec 2017
- Primary completion1 Dec 2019
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rheumatic Valvular Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ning Ding, Nanjing Medical University
- Investigators
- Ning Ding, MD, PhD, Study chair, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03398733
- Sponsor's protocol ID
- 2017-SR-040
- Acronym
- CPAP
- Status last verified
- Feb 2020
- First submitted
- 1 Jan 2018
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 27448416Su 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.
PubMed 37342775
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative CPAP Treatment on Perioperative Outcomes in Rheumatic Valvular Heart Disease Patients With OSA
- ClinicalTrials.gov ID
- NCT03398733
- Acronym / sponsor ID
- CPAP / 2017-SR-040
- Keywords
- Obstructive Sleep Apnea, heart valve replacement, CPAP treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 12 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| continuous positive airway pressure | Other | Device: continuous positive airway pressureThe CPAP treatment group received both baseline and CPAP treatment for 7 days preoperatively. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| continuous positive airway pressureThe CPAP treatment group received both baseline and CPAP treatment for 7 days preoperatively. The non-CPAP treatment group only received baseline treatment. | Device | continuous positive airway pressure |
Primary outcome
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.
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.
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.
3 secondary outcomes
mean and lowest SPO2
Time frame: 2 weeks,depends on length of hospital stay
pacemaker use
Time frame: 3 days, depends on the patient's recovery
complicated infection and reintubation
Time frame: 3 days, depends on the patient's recovery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Background: PubMed 27448416Ding 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.
- Derived from this study: PubMed 37342775Su 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ning Ding, MD, PhD study chair
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing continuous positive airway pressure in people with Rheumatic Valvular Heart Disease and Obstructive Sleep Apnea, run by Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
apnea-hypopnea index (AHI) (time frame: 2 weeks,depends on length of hospital stay). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03398733, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020.