Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cardiac and Respiratory Function With Non-invasive Ventilation (CARE-NIV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02699112
Recruitment Status : Completed
First Posted : March 4, 2016
Last Update Posted : April 11, 2018
Sponsor:
Collaborators:
University of Padova
King's College London
Lane Fox Respiratory
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

Brief Summary:
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.

Condition or disease Intervention/treatment
OHS Hypercapnic Respiratory Failure Other: Parasternal EMG (EMGpara) and Transthoracic Echocardiography

Detailed Description:

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 22 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Actual Study Start Date : November 2015
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: 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.


Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting with a confirmed diagnosis of OHS and Overlap Syndrome and hypercapnic respiratory failure with the clinical intervention to commence on NIV will be invited to participate in the trial.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02699112


Locations
Layout table for location information
United Kingdom
Guys and St Thomas NHS Foundation
London, United Kingdom, SE1 7EH
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
University of Padova
King's College London
Lane Fox Respiratory
Investigators
Layout table for investigator information
Principal Investigator: Joerg Dr Steier Guys and St Thomas' NHS Foundation Trust
Principal Investigator: Marino Dr Phil Guys and St Thomas' NHS Foundation Trust
Additional Information:
Layout table for additonal information
Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02699112    
Other Study ID Numbers: 179324
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Insufficiency
Hypercapnia
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory