Myocardial Effects of NIV in OHS Patients

NCT06486129 | Completed

• 1 other identifier: VEGA 1/0220/17
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Failure Chronic; Obesity Hypoventilation Syndrome; Obstructive Sleep Apnea; Cardiac Output, Low

Keywords

Respiratory Failure; Obesity Hypoventilation Syndrome; Obstructive Sleep Apnea; Cardiac Output; stroke volume

Outcome Measures

Primary Outcomes (1)

• Impedance cardiography measured cardiac output

  Impedance cardiography measured cardiac output before and after effective treatment of respiratory failure

  12 months

Secondary Outcomes (1)

• Impedance cardiography measured stroke volume

  12 months

Study Arms (1)

Obesity hypoventilation syndrome patients treated with BPAP (NIV) therapy

EXPERIMENTAL

Clinically stable patients with OHS and severe hypercapnia during the daytime, referred to the tertiary clinic for the initiation of long-term NIV to alleviate chronic respiratory failure were consecutively enrolled to the study

Procedure: Noninvasive ventilation volume targetted

Interventions

Noninvasive ventilation volume targetted PROCEDURE

he 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

Obesity hypoventilation syndrome patients treated with BPAP (NIV) therapy

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Clinically stable patients with OHS and chronic severe hypercapnia

You may not qualify if:

• 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

Sponsors & Collaborators

• Pavol Jozef Safarik University: lead

Study Sites (1)

Department of respiratory medicine and tuberculosis, Pavol Jozef Safarik University, Medical Faculty and L. Pasteur University Hospital In Kosice

Košice, 04190, Slovakia

Location

Related Publications (1)

• Pobeha P, Paranicova I, Trojova I, Tkacova R, Joppa P. Acute hemodynamic effects of non-invasive ventilation in patients with obesity hypoventilation syndrome. Bratisl Lek Listy. 2021;122(4):248-250. doi: 10.4149/BLL_2021_040.

  PMID: 33729816 BACKGROUND

MeSH Terms

Conditions

Obesity Hypoventilation Syndrome; Sleep Apnea, Obstructive; Cardiac Output, Low; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Hypoventilation; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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: Pavol Pobeha, MD, PhD (Principal investigator)

Model Details: Clinically stable patients with OHS and severe hypercapnia during the daytime, referred to the tertiary clinic for the initiation of long-term NIV to alleviate chronic respiratory failure were consecutively enrolled to the study

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: July 3, 2024
• Study Start: March 1, 2016
• Primary Completion: November 15, 2019
• Study Completion: January 15, 2020
• Last Updated: July 3, 2024

Record last verified: 2024-06

Locations

SL (1)