Ventilation therapy supports heart functioning in obese people with respiratory failure

ISRCTN	ISRCTN16950250
DOI	https://doi.org/10.1186/ISRCTN16950250
Secondary identifying numbers	2016/EK/3003

Submission date: 21/06/2024
Registration date: 18/07/2024
Last edited: 18/07/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
In patients with obesity hypoventilation syndrome (OHS), a condition in which severely overweight people fail to breathe rapidly or deeply enough, breathing support with ventilation therapy has been shown to improve blood pressure in the lung circulation and improve some heart functions as well. However, it is not yet known if these benefits last over the long term. So, the aim of this study is to examine the long-term effects of a specific type of noninvasive ventilation on heart function and heart-related biomarkers in patients with OHS.

Who can participate?
Clinically stable subjects with obesity hypoventilation syndrome that requires management with ventilation therapy

What does the study involve?
Participants receive standard ventilation treatment for OHS using standardized internationally recommended protocols. Before starting the treatment, they undergo an assessment of their heart function using a novel non-invasive technique that requires the placement of three electrodes on their skin. In addition, blood is drawn to measure parameters that are linked to heart functioning. The same procedures and measurements are repeated after 3 and 12 months of the use of ventilatory support on a daily basis.

What are the possible benefits and risks of participating?
The benefits of participating in the study:
1. Receiving state-of-the-art ventilatory support with regular monitoring and health assessment. This can lead to early detection and management of potential complications, ensuring better health outcomes.
2. Improved symptom control: Ventilatory support is essential for treating respiratory failure and maintaining physiological levels of blood gases in the circulating blood (oxygen and carbon dioxide). Consequently, increased oxygen levels and reduced carbon dioxide levels result in improved control of symptoms such as fatigue, headaches, confusion, cognitive impairment, and/or sleep disturbances.
3. Alleviating obstructive sleep apnea and its symptoms, such as snoring, repetitive multiple breathing cessation during sleep, gasping or choking sensations during sleep, excessive daytime sleepiness, difficulty concentrating, irritability or mood changes, dry mouth or sore throat upon awakening, restless or unrefreshing sleep, nocturia, decreased libido, and heartburn.
4. Personalized medical attention, ensuring that treatment is tailored to each patient’s specific needs, potentially leading to more effective management of their condition. Personalized attention also provides participants with emotional support and practical personalized advice for managing their condition.
5. Enhancing daily functioning and quality of life with important potential long-term benefits: reduced hospitalizations and increased life expectancy.

The risks of participating in the study:
1. Adverse effects associated with ventilatory support: skin irritation and pressure sores resulting from wearing ventilatory masks, nasal dryness and congestion, and gastric distension.
2. Respiratory infections associated with ventilatory support – these are prevented by following stringent hygienic protocols and using disposable ventilatory masks.
3. Sleep disruption in case of discomfort or poor fit related to ventilation masks or the noise from the ventilatory devices – these are prevented by diligent observation and monitoring by a trained certified sleep technician during the introduction of noninvasive ventilation. Should any of these occur, adjustments are made to the ventilation mask and interface.
4. Discomfort during the impedance cardiography measurements resulting from lying on your back throughout the procedure.
5. Risks related to blood draws: local discomfort, bruising, or infection at the puncture site.

Where is the study run from?
PJ Safarik University, Kosice, and L Pasteur University Hospital in Kosice (Slovakia)

When is the study starting and how long is it expected to run for?
March 2016 to November 2019

Who is funding the study?
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)

Who is the main contact?
1. Dr Pavol Pobeha, pavol.pobeha@upjs.sk
2. Dr Ivana Paranicova, ivana.paranicova@upjs.sk

Contact information

Dr Pavol Pobeha
Principal Investigator

Rastislavova 43
Kosice
04190
Slovakia

ORCID ID	0000-0003-3074-867X
Phone	+421 (0)556152642
Email	pavol.pobeha@upjs.sk

Dr Ivana Paranicova
Scientific

Rastislavova 43
Kosice
04190
Slovakia

ORCID ID	0000-0003-1774-6653
Phone	+421 (0)556152642
Email	ivana.paranicova@upjs.sk

Dr Pavol Pobeha
Public

Rastislavova 43
Kosice
04190
Slovakia

ORCID ID	0000-0003-3074-867X
Phone	+421 (0)556152642
Email	pavol.pobeha@upjs.sk

Study information

Study design	Non-randomized study
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Other, Treatment, Safety
Participant information sheet	Not available in web format, please use the contact details to request a participant information sheet
Scientific title	Long-term myocardial effects of noninvasive ventilation in patients with obesity hypoventilation syndrome
Study objectives	Chronic effects of noninvasive ventilation (NIV) on myocardial function in patients with obesity hypoventilation syndrome (OHS) are scarcely understood. The aim of the present study is 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.
Ethics approval(s)	Approved 30/03/2016, Ethics committee of L. Pasteur University Hospital (Rastislavova 43, Košice, 04190, Slovakia; +421 (0)55 615 2642; eticka.komisia@unlp.sk), ref: 2016/EK/3003
Health condition(s) or problem(s) studied	Obesity hypoventilation syndrome, chronic hypercapnic respiratory failure
Intervention	At baseline, all patients were assessed for meeting the inclusion criteria, including history, physical examination, anthropometry, transthoracic echocardiography (Aloka, Tokyo, Japan), spirometry (Ganshorn PowerCube, LF8.5F Release 2), and blood gas analysis. All eligible subjects then underwent a sleep study, ICG, and blood sampling for biomarkers assessment. BiPAP therapy was initiated and patients were instructed to use BiPAP at home every night and also while napping during the daytime. Repeated ICG assessment and blood sample analyses were performed after 3 and 12 months of home-based BiPAP use. The nightly use of BiPAP was evaluated by software analysis embedded in the ventilators. Compliance with BiPAP therapy was deemed sufficient when the patient used the ventilator on average for >4 hours/night.
Intervention type	Device
Pharmaceutical study type(s)	Not Applicable
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Noninvasive ventilation, bilevel positive airway pressure, specifically Lowenstein Prisma 30ST
Primary outcome measure	Cardiac output (in litres per minute), stroke volume (in milliliters), and heart rate (in beats per minute) measured by impedance cardiography (ICG) at baseline, and after 3 and 12 months of using noninvasive ventilation for treatment of chronic respiratory failure
Secondary outcome measures	Biochemical markers analysed in venous blood: serum troponin 1 (pg/ml), N-terminal pro-B-type natriuretic peptide (pg/ml), tumor necrosis factor-alpha (pg/ml), and interleukin-6 (pg/ml), measured at baseline, and after 3 and 12 months of using non-invasive ventilation for treatment of chronic respiratory failure
Overall study start date	01/03/2016
Completion date	15/11/2019

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	35 Years
Upper age limit	80 Years
Sex	Both
Target number of participants	30
Total final enrolment	13
Key inclusion criteria	1. Clinically stable patients with OHS and severe hypercapnia during the daytime 2. Referred to the tertiary clinic for the initiation of long-term NIV to alleviate chronic respiratory failure
Key exclusion criteria	1. Inability to provide written informed consent 2. Neuromuscular, chest wall, or metabolic disease resulting in hypercapnia 3. Acute respiratory tract infection 4. Chronic obstructive pulmonary disease (COPD) 5. Systolic LV failure as evidenced by LV ejection fraction <45% on transthoracic echocardiography
Date of first enrolment	01/06/2016
Date of final enrolment	15/10/2018

Locations

Countries of recruitment

Slovakia

Study participating centre

Department of Respiratory Medicine and Tuberculosis, Pavol Jozef Safarik University, Medical Faculty and L. Pasteur University Hospital In Kosice

Rastislavova 43
Kosice
04190
Slovakia

Sponsor information

University of Pavol Jozef Šafárik
University/education

Trieda SNP1
Košice
040 01
Slovakia

Phone	+421 (0)556152642
Email	pavol.joppa@upjs.sk
Website	http://www.upjs.sk/
"ROR"	https://ror.org/039965637

Funders

Funder type

Government

Vedecká Grantová Agentúra MŠVVaŠ SR a SAV
Government organisation / Local government

Alternative name(s): Scientific Grant Agency, VEGA
Location: Slovakia

Results and Publications

Intention to publish date	01/07/2024
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	The researchers plan to publish the data from the study in a Q1-Q2 journal after completing the study and preparing the manuscript. Data were presented at the European Respiratory Congress in Madrid (Spain) in September 2019.
IPD sharing plan	The datasets generated during and/or analysed during the current study will be available upon request from Dr Ivana Paranicova (ivana.paranicova@upjs.sk). The type of data that will be shared: data spreadsheets for all parameters recorded during impedance cardiography; biochemical parameters, demographics. The researchers anonymized data using a combination of techniques to protect individual privacy while maintaining the utility of the data for research purposes, following established guidelines and best practices (General Data Protection Regulation [GDPR] for personal data in the European Union). They removed direct and/or specific identifiers from all research databases, such as names, social security numbers, email addresses, residential addresses, phone numbers, and medical record numbers, and birthdates. Unique codes were assigned to each participant instead of using their names. The Ethics Committee of the Faculty of Medicine, PJ Safarik University in Kosice, Slovakia (https://www.upjs.sk/app/uploads/sites/9/2023/09/Statut_EK_UPJS_LF_2007_ENG.pdf) raised no ethical or legal concerns or restrictions.

Editorial Notes

24/06/2024: Study's existence confirmed by the Scientific Grant Agency of the Ministry of Education, Science, Research and Sport of the Slovak Republic and the Slovak Academy of Sciences.