Long-term Myocardial Effects of Noninvasive Ventilation in Patients With Obesity Hypoventilation Syndrome
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Respiratory Failure Chronic
- Sponsor
- Pavol Jozef Safarik University
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- Impedance cardiography measured cardiac output
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
Chronic effects of noninvasive ventilation on myocardial function in patients with obesity hypoventilation syndrome (OHS) are scarcely understood. The aim of the present study was to evaluate the long-term effects of volume-targeted bilevel-positive airway pressure ventilation (BiPAP) on cardiac parameters and myocardial biomarkers in patients with OHS.
Detailed Description
Chronic effects of non- invasive ventilation on myocardial function in patients with obesity hypoventilation syndrome (OHS) are scarcely understood. The aim of the present study was to evaluate the long-term effects of volume-targeted bilevel-positive airway pressure ventilation (BiPAP) on cardiac parameters and myocardial biomarkers in patients with OHS. Clinically stable patients with OHS referred to the tertiary centre for the initiation of long-term BiPAP therapy were consecutively enrolled in the study. At baseline, all participants underwent overnight cardiorespiratory polygraphy. BiPAP therapy using volume-targeted spontaneous/timed mode delivered via an oro-nasal mask was initiated. Beat-to-beat noninvasive monitoring by impedance cardiography was used to assess heart function at baseline and after 3 and 12 months of BiPAP use. Serum troponin 1, N-Terminal Pro-B-Type Natriuretic Peptide (NTProBNP), tumor necrosis factor-alpha (TNF-α), and interleukin-6 (IL-6) were monitored. Potential risks and benefits comprise haemodynamic effects of NIV on cardiovascular parameters including cardiac output and stroke volume. The study started 06/2016 and enrolment was finalized in October 2018. The study was funded by grants from the Slovak Research and Development Agency under contract No. APVV-16-0158, and VEGA 1/0220/17 and 1/0393/22 of the Ministry of Education, Slovakia. The main investigator is Pavol Pobeha, MD, PhD, co author is Ivana Paranicova, MD, PhD and the corresponding author (study coordinator prof. Ruzena Tkacova, MD, PhD)
Investigators
Pavol Pobeha
Pavol Pobeha, MD, PhD (Principal investigator)
Pavol Jozef Safarik University
Eligibility Criteria
Inclusion Criteria
- •Clinically stable patients with OHS and chronic severe hypercapnia
Exclusion Criteria
- •inability to provide written informed consent
- •neuromuscular diseases
- •chest wall diseases
- •metabolic diseases
- •acute respiratory tract infection
- •chronic obstructive pulmonary disease (COPD)
- •systolic LV failure as evidenced by LV ejection fraction\<45% on echocardiography
Outcomes
Primary Outcomes
Impedance cardiography measured cardiac output
Time Frame: 12 months
Impedance cardiography measured cardiac output before and after effective treatment of respiratory failure
Secondary Outcomes
- Impedance cardiography measured stroke volume(12 months)