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Completed

NCT Number: NCT02699112

Cardiac and Respiratory Function With Non-invasive Ventilation

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.

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Key information

Conditions

OHS Hypercapnic Respiratory Failure Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Guys and St Thomas NHS Foundation

London, SE1 7EH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Parasternal EMG (EMGpara) and Transthoracic Echocardiography

Other

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

Primary outcomes

  1. Patients commencing on Non Invasive Ventilation (NIV); change in Cardiac Function from baseline and at 3 months

    Time frame: 3 months

    Patients with hypercapnic respiratory failure caused by obesity hypoventilation syndrome commencing on NIV; change in cardiac function using echocardiography at baseline and 3 months. Measurements taken prior to NIV initiation, and follow up at 3 months.

  2. Patients commencing on Non Invasive Ventilation (NIV); change on Nueral Respiratory Drive (NRD) from baseline and at 3 months

    Time frame: 3 months

    Patients with hypercapnic respiratory failure caused by obesity hypoventilation syndrome commencing on NIV; change in markers of nerual respiratory drive/EMG para. Measurements taken prior to, and after NIV initiation, and follow up at 3 months.

Secondary outcomes

  1. Patients commencing on Non Invasive Ventilation (NIV); change in Oxygenation from baseline, 6 weeks post initiation and at 3 months

    Time frame: 3 months

    To demonstrate that the improvement in cardiac function and/or respiratory mechanics over time are associated with ongoing improvements in oxygenation by taking samples of arterial blood gases.

    Measurements are made prior to, during and after NIV initiation, and follow up at 3 months.

  2. Patients commencing on Non Invasive Ventilation (NIV); change in Quality of Life from baseline, 6 weeks post initiation and at 3 months

    Time frame: 3 months

    To demonstrate the hypothesis that the improvement in cardiac function and/or respiratory mechanics over time are associated with ongoing improvements in quality of life by asking participants to complete the Medical Research Council (MRC) dyspnoea scale. Measurement will be taken prior to NIV initiation, 6 weeks post initiation and at follow up at 3 months.

  3. Patients commencing on Non Invasive Ventilation (NIV); change in Quality of Life from baseline, 6 weeks post initiation and at 3 months

    Time frame: 3 months

    To demonstrate the hypothesis that the improvement in cardiac function and/or respiratory mechanics over time are associated with ongoing improvements in quality of life by asking participants to complete the modified BORG Scale (breathlessness). Measurement will be taken prior to NIV initiation, 6 weeks post initiation and at follow up at 3 months.

  4. Patients commencing on Non Invasive Ventilation (NIV); change in Quality of Life from baseline, 6 weeks post initiation and at 3 months

    Time frame: 3 months

    To demonstrate the hypothesis that the improvement in cardiac function and/or respiratory mechanics over time are associated with ongoing improvements in quality of life by asking participants to complete the St George's Respiratory Questionnaire (SGRQ). Measurement will be taken prior to NIV initiation, 6 weeks post initiation and at follow up at 3 months.

  5. Patients commencing on Non Invasive Ventilation (NIV); change in Quality of Life from baseline, 6 weeks post initiation and at 3 months

    Time frame: 3 months

    To demonstrate the hypothesis that the improvement in cardiac function and/or respiratory mechanics over time are associated with ongoing improvements in quality of life by asking participants to complete the Hospital Anxiety and Depression Scale (HADS).

    Measurement will be taken prior to NIV initiation, 6 weeks post initiation and at follow up at 3 months.

  6. Patients commencing on Non Invasive Ventilation (NIV); change in Quality of Life from baseline, 6 weeks post initiation and at 3 months

    Time frame: 3 months

    To demonstrate the hypothesis that the improvement in cardiac function and/or respiratory mechanics over time are associated with ongoing improvements in quality of life by asking participants to complete the Epworth Sleepiness Scale (ESS).

    Measurement will be taken prior to NIV initiation, 6 weeks post initiation and at follow up at 3 months.

  7. Patients commencing on Non Invasive Ventilation (NIV); change in Exercise Capacity.

    Time frame: 3 months

    To demonstrate that the improvement in cardiac function and/or respiratory mechanics over time are associated with ongoing improvements in oxygenation by participants performing the Gate speed of 4 metres test prior to,during and after NIV initiation and at 6 weeks post initiation, and follow up at 3 months.

Sponsors and collaborators

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Other

Collaborators

  • King's College London
  • Lane Fox Respiratory
  • University of Padova

Registry information

Official study title

Improvement of Cardiac Function and Neural Respiratory Drive Following Set up of Non-invasive Ventilation in Patients With Hypercapnic Respiratory Failure Caused by Obesity Hypoventilation Syndrome

Acronym: CARE-NIV

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 4, 2016
Registry last updated
Apr 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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