Cardiac and Respiratory Function With Non-invasive Ventilation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2018-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To assess patients with hypercapnic respiratory failure using echocardiography,cardiac output measurements and markers of neural respiratory drive (EMGpara) prior to, during and after non-invasive ventilation (NIV) initiation, and to follow the patients for 3 months. The investigators hypothesize that the improvement in cardiac function and/or respiratory mechanics over time are associated with ongoing improvements in oxygenation, quality of life and exercise capacity.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Patient -Ventilator Interaction in Chronic Respiratory Failure

NCT01371149

Chronic Hypercapnic Respiratory Failure Obesity Hypoventilation Syndrome Neuromuscular Disease +1 more

COMPLETED PHASE2

Resting Energy Expenditure in Patients With OHS Treated With Long-term NIV

NCT04474587

Obesity-hypoventilation Syndrome Resting Energy Expenditure Long-term Non-invasive Ventilation

SUSPENDED

Evaluation of Prolonged Apnea Supported by High Frequency Non-invasive Ventilation.

NCT02712190

Non-invasive Ventilation High-frequency Ventilation Healthy Volunteer +1 more

UNKNOWN NA

HVNI Versus NIV In Management Of Acute Hypercapnic Respiratory Failure In OHS

NCT05805293

Obesity Hypoventilation Syndrome (OHS)

UNKNOWN NA

Deventilation Dyspnea in COPD Patients Using NIV

NCT03503123

COPD Dyspnea Mechanical Ventilation Complication

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Respiratory failure is characterized by the incapacity of the respiratory system to maintain the normal arterial blood gas homeostasis. Specifically, the overlap of hypoxaemia and hypercapnia (PaCO2 \>6 kPa) is referred to as Hypercapnic Respiratory Failure (HRF). HRF is one of the most common causes for hospital admission with high re-admission rates, therefore constitute a major burden on healthcare systems. Non Invasive Ventilation (NIV) is a well established treatment in patients with hypercapnic respiratory failure who frequently suffer with associated pulmonary hypertension (PH). NIV helps to increase arterial oxygenation and reduces hypercapnia. It is used in patients with hypercapnic respiratory failure caused by Obesity Hypoventilation Syndrome (OHS). The associated degree of PH can lead to an increased afterload of the right ventricle (RV) that causes progressive remodelling of the right heart. RV dysfunction is correlated with a reduced long term prognosis in respiratory conditions. In literature NIV is shown as effective method to treat acute hypercapnic respiratory failure in OHS.

It has not been described how NIV impacts on cardiac function and NRD in OHS.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

OHS Hypercapnic Respiratory Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Parasternal EMG (EMGpara) and Transthoracic Echocardiography

OHS patients recruited will have EMGpara and Transthoracic Echocardiography at admission and when established on NIV at 3 months.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Confirmed diagnosis of OHS and Overlap Syndrome
* Hypercapnic respiratory failure with the need to commence NIV
* Expected to remain an inpatient for ≥ 24 hours
* Age ≥ 18 and \<80 years
* BMI \>30 kg/m2
* Confirmed sleep-disordered breathing
* Able to give informed consent to participation in the evaluation study
* Clinically stable without exacerbations for ≥ 6 weeks

Exclusion Criteria

* Patients established on NIV
* Inability to tolerate NIV (\< 4 hours usage at during hospital titration)
* Contraindication to NIV
* Requirement for immediate invasive mechanical ventilation at admission or any other acute critical illness
* Acute infective exacerbation
* Presence of other acute pathology or critical illness (such as pulmonary embolism)
* Presence of acute or chronic Left ventricular Cardiac Failure
* Significant Kidney or Liver disease
* Significant Anaemia
* History of Pulmonary Embolism in the previous 2 years
* Presence of cardiac congenital disease
* Presence of Primary Pulmonary Hypertension
* Presence of other severe medical problem, e.g. cancer and systemic connective tissue disease and vasculitides
* Pregnancy
* Psychological and social factors that would impair compliance with the evaluation

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No