OHSCARE-NIVNCT02699112
Cardiac and Respiratory Function With Non-invasive Ventilation
An observational study of OHS and Hypercapnic Respiratory Failure, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- OHS, Hypercapnic Respiratory Failure
- What is being tested?
- Parasternal EMG (EMGpara) and Transthoracic Echocardiography
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2015to Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- OHS, Hypercapnic Respiratory Failure
- Being tested
- Parasternal EMG (EMGpara) and Transthoracic Echocardiography
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parasternal EMG (EMGpara) and Transthoracic EchocardiographyOther
OHS patients recruited will have EMGpara and Transthoracic Echocardiography at admission and when established on NIV at 3 months.
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients commencing on Non Invasive Ventilation (NIV); change in Cardiac Function from baseline and at 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.
Measured: 3 months
Patients commencing on Non Invasive Ventilation (NIV); change on Nueral Respiratory Drive (NRD) from baseline and at 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.
Measured: 3 months
Secondary outcomes (7)
Patients commencing on Non Invasive Ventilation (NIV); change in Oxygenation from baseline, 6 weeks post initiation and at 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.
Measured: 3 months
Patients commencing on Non Invasive Ventilation (NIV); change in Quality of Life from baseline, 6 weeks post initiation and at 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.
Measured: 3 months
Patients commencing on Non Invasive Ventilation (NIV); change in Quality of Life from baseline, 6 weeks post initiation and at 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.
Measured: 3 months
Patients commencing on Non Invasive Ventilation (NIV); change in Quality of Life from baseline, 6 weeks post initiation and at 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.
Measured: 3 months
Patients commencing on Non Invasive Ventilation (NIV); change in Quality of Life from baseline, 6 weeks post initiation and at 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.
Measured: 3 months
Patients commencing on Non Invasive Ventilation (NIV); change in Quality of Life from baseline, 6 weeks post initiation and at 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.
Measured: 3 months
Patients commencing on Non Invasive Ventilation (NIV); change in Exercise Capacity.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2016 (estimated)
- Study startNov 2015
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OHSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Padova, King's College London, Lane Fox Respiratory
- Responsible party
- Sponsor
- Investigators
- Joerg Dr Steier, Principal investigator, Guy's and St Thomas' NHS Foundation TrustMarino Dr Phil, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02699112
- Sponsor's protocol ID
- 179324
- Acronym
- CARE-NIV
- Status last verified
- Apr 2018
- First submitted
- 27 Jan 2016
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02699112
- Acronym / sponsor ID
- CARE-NIV / 179324
- Conditions
- OHS, Hypercapnic Respiratory Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Padova, King's College London, Lane Fox Respiratory
- Study start
- Nov 2015 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 4 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parasternal EMG (EMGpara) and Transthoracic EchocardiographyOHS patients recruited will have EMGpara and Transthoracic Echocardiography at admission and when established on NIV at 3 months. | Other | – |
Primary outcome
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.
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.
7 secondary outcomes
Patients commencing on Non Invasive Ventilation (NIV); change in Oxygenation from baseline, 6 weeks post initiation and at 3 months
Time frame: 3 months
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
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
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
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
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
Patients commencing on Non Invasive Ventilation (NIV); change in Exercise Capacity.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
- JTD publicationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joerg Dr Steier principal investigator
Guy's and St Thomas' NHS Foundation Trust
Marino Dr Phil principal investigator
Guy's and St Thomas' NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of OHS and Hypercapnic Respiratory Failure, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients commencing on Non Invasive Ventilation (NIV); change in Cardiac Function from baseline and at 3 months (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2018.