Heart Function TestsNCT02267291
Impact of Non-invasive Positive Pressure Ventilation on Cardiac Function and Echocardiographic Parameters
A study testing Non-invasive positive pressure ventilation in people with Heart Function Tests and Hemodynamics, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Cardiologists and intensive care specialists are confronted daily with mechanically ventilated patients exhibiting cardiac failure. It is of paramount importance to understand the effect of mechanical ventilation on cardiac function and to interpret echocardiographic findings correctly in order to provide the patient… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Function Tests, Hemodynamics, Noninvasive Ventilation
- What is being tested?
- Non-invasive positive pressure ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2015to Feb 2018
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 to ≤ 75 years
- Indication for a coronary angiogram
- Written informed consent obtained
- Adequate echocardiographic imaging quality
- • Patient tolerates a face mask for non-invasive ventilation
Who cannot join
- Acute coronary syndrome
- Previous myocardial infarction or open heart surgery
- Severe obstructive or restrictive pulmonary disease
- Pulmonary hypertension
- Diastolic dysfunction ≥ grade II
- Valvular heart disease > grade I
Show all 13Show fewer
- Left ventricular ejection fraction < 50%
- Complete left or right bundle branch block
- Cardiac pacemaker or defibrillator
- Atrial fibrillation or frequent premature beats
- INR > 3.0 or haemoglobin < 90g/l
- Glomerular filtration rate < 45ml/min/1.73m2
- Esophageal disorders
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Cardiology, Bern University Hospital
Bern, Canton of Bern, 3010
About this study
Cardiologists and intensive care specialists are confronted daily with mechanically ventilated patients exhibiting cardiac failure. It is of paramount importance to understand the effect of mechanical ventilation on cardiac function and to interpret echocardiographic findings correctly in order to provide the patient with the best possible treatment to support cardiac and circulatory function. Currently physicians interpret echocardiographic findings based on studies that were performed in spontaneously breathing patients. With this study, the investigators intend to contribute to the understanding of cardiac physiology in patients needing ventilatory support, especially they aim to provide the physiological basis for the interpretation of echocardiographic findings in order to improve medical support (e.g. fluid resuscitation, vasoactive drugs, ventilation strategy) of ventilated patients with impaired cardiovascular function.
Read the detailed description
Background
Mechanical ventilation (MV) is commonly used in intensive care units (ICU) to improve gas exchange and to reduce breathing effort. The need for MV is the single most prominent reason for admission to an intensive care unit, either for acute cardiac or respiratory failure, postoperative ventilation or other reasons. Its usefulness is not limited to critically ill patients but has also gained recognition in treating sleep-related breathing disorders. Soon after the introduction of MV to clinical practice its adverse hemodynamic effects were noted and have been studied ever since. It is now well accepted that MV, by applying external positive pressure in order to achieve tidal breathing, affects lung volume and intrathoracic pressure which in turn influence cardiac loading and function.
Echocardiography is increasingly used in intensive care to evaluate hemodynamics and especially Doppler assessments of mitral inflow and annular tissue velocity to describe left ventricular (LV) diastolic function. There is a growing body of evidence stating that diastolic dysfunction is a key factor for weaning failure from MV, a clinical issue affecting up to one third of patients. Worsened diastolic LV filling under MV may decisively lower cardiac performance and cause hemodynamic instability especially in case of pre-existing diastolic dysfunction in patients with arterial hypertension, a disease with a high prevalence of 30-45% in the general population. So far, despite the extensive use of echocardiography in ventilated patients, the causative pathophysiological mechanisms underlying ventilation-induced changes of echocardiographic parameters used to determine diastolic LV function have never been thoroughly evaluated. Assessing diastolic function during MV is complex since Doppler derived surrogate parameters all depend on cardiac loading conditions and loading itself is inevitably coupled to MV. The question therefore arises whether echocardiography allows for detection of deteriorating LV diastolic function in terms of impaired intrinsic ventricular relaxation or LV stiffness or whether it primarily mirrors MV-induced loading alterations. It is important to differentiate if echocardiographic signs of diastolic dysfunction in the patient under MV are caused by changes in loading or a LV filling restraint since in case of hemodynamic instability the two scenarios would ask for different therapeutic measures. In case of a loading problem, pre- and afterload can be targeted using drugs or fluid resuscitation. If a MV-induced filling restraint is the predominant problem one may consider special ventilatory modes or even deep sedation and the use of muscle relaxants to minimize Pit.
The basic concepts of heart-lung interactions under positive pressure ventilation make it conceivable that extrinsic pressure applied to the thorax and therefore, as explained later in more detail, to the heart may mimic diastolic dysfunction even in a totally healthy heart if assessed by echocardiography. Echocardiographic parameters to assess diastolic function have been evaluated against the gold standard - invasive LV pressure and volume measurements - in spontaneously breathing patients. Such an evaluation is lacking for the patient with ventilatory support and therefore the value of echocardiography for assessment of diastolic function under MV needs further clarification. The investigators intend to comparatively study cardiac and particularly left ventricular diastolic function in ventilated patients using both invasive and ultrasound methods.
Objective
The presented study will elucidate the influence of positive pressure ventilation on cardiac function in humans. Furthermore, the investigators aim to describe the changes of echocardiographic parameters under different levels of positive pressure ventilation and link these changes to the underlying pathophysiological alterations in hemodynamics induced by positive pressure ventilation.
Methods
Prospective single-centre study at the University Hospital Berne. 30 patients scheduled for an elective coronary angiogram will be included. During spontaneous breathing and two different levels of non-invasive PPV transthoracic echocardiography is performed while recording LV-pressure-volume loops using an impedance catheter. Simultaneously the pulmonary artery occlusion pressure, the right atrial pressure and the intrathoracic pressure are recorded using a pulmonary artery catheter and an oesophageal balloon respectively.
- Conditions
- Heart Function Tests, Hemodynamics, Noninvasive Ventilation, Circulatory and Respiratory Physiological Phenomena
- Being tested
- Non-invasive positive pressure ventilation
- Keywords
- Cardiac Catheterization, Echocardiography, Noninvasive Ventilation, Positive-Pressure Respiration, Ventricular Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive positive pressure ventilationOther
Ventilatory support to alter intrathoracic pressure
| Study group | Role | What they receive |
|---|---|---|
| All patients | Experimental | Ventilatory support to alter intrathoracic pressure Receives: Other: Non-invasive positive pressure ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular diastolic function
Assessed by pressure volume loops
Measured: Under spontaneous breathing and at two levels of positive pressure ventilation, 5 minutes after changing positive end-expiratory pressure
Secondary outcomes (3)
Left ventricular contractility
Assessed by pressure volume loops
Measured: Under spontaneous breathing and at two levels of positive pressure ventilation, 5 minutes after changing positive end-expiratory pressure
Cardiac function
Assessed by echocardiography
Measured: Under spontaneous breathing and at two levels of positive pressure ventilation, 5 minutes after changing positive end-expiratory pressure
Invasively measured alterations in hemodynamics
Alterations of invasively measured hemodynamic parameters including cardiac output and pulmonary artery, right ventricular and right atrial pressures
Measured: Under spontaneous breathing and at two levels of positive pressure ventilation, 5 minutes after changing positive end-expiratory pressure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startJun 2015
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Function TestsStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan Blöchlinger, MD, PhD, Principal investigator, Department of Cardiology, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02267291
- Sponsor's protocol ID
- 104/14
- Status last verified
- Oct 2018
- First submitted
- 11 Sep 2014
- Last updated
- 30 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Berger D, Wigger O, de Marchi S, Grubler MR, Bloch A, Kurmann R, Stalder O, Bachmann KF, Bloechlinger S. The effects of positive end-expiratory pressure on cardiac function: a comparative echocardiography-conductance catheter study. Clin Res Cardiol. 2022 Jun;111(6):705-719. doi: 10.1007/s00392-022-02014-1. Epub 2022 Apr 6.
PubMed 35381904
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Non-invasive Positive Pressure Ventilation on Cardiac Function and Echocardiographic Parameters
- ClinicalTrials.gov ID
- NCT02267291
- Acronym / sponsor ID
- 104/14
- Conditions
- Heart Function Tests, Hemodynamics, Noninvasive Ventilation, Circulatory and Respiratory Physiological Phenomena
- Keywords
- Cardiac Catheterization, Echocardiography, Noninvasive Ventilation, Positive-Pressure Respiration, Ventricular Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 17 Oct 2014 (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.
Cardiologists and intensive care specialists are confronted daily with mechanically ventilated patients exhibiting cardiac failure. It is of paramount importance to understand the effect of mechanical ventilation on cardiac function and to interpret echocardiographic findings correctly in order to provide the patient with the best possible treatment to support cardiac and circulatory function. Currently physicians interpret echocardiographic findings based on studies that were performed in spontaneously breathing patients. With this study, the investigators intend to contribute to the understanding of cardiac physiology in patients needing ventilatory support, especially they aim to provide the physiological basis for the interpretation of echocardiographic findings in order to improve medical support (e.g. fluid resuscitation, vasoactive drugs, ventilation strategy) of ventilated patients with impaired cardiovascular function.
Detailed description
Background
Mechanical ventilation (MV) is commonly used in intensive care units (ICU) to improve gas exchange and to reduce breathing effort. The need for MV is the single most prominent reason for admission to an intensive care unit, either for acute cardiac or respiratory failure, postoperative ventilation or other reasons. Its usefulness is not limited to critically ill patients but has also gained recognition in treating sleep-related breathing disorders. Soon after the introduction of MV to clinical practice its adverse hemodynamic effects were noted and have been studied ever since. It is now well accepted that MV, by applying external positive pressure in order to achieve tidal breathing, affects lung volume and intrathoracic pressure which in turn influence cardiac loading and function.
Echocardiography is increasingly used in intensive care to evaluate hemodynamics and especially Doppler assessments of mitral inflow and annular tissue velocity to describe left ventricular (LV) diastolic function. There is a growing body of evidence stating that diastolic dysfunction is a key factor for weaning failure from MV, a clinical issue affecting up to one third of patients. Worsened diastolic LV filling under MV may decisively lower cardiac performance and cause hemodynamic instability especially in case of pre-existing diastolic dysfunction in patients with arterial hypertension, a disease with a high prevalence of 30-45% in the general population. So far, despite the extensive use of echocardiography in ventilated patients, the causative pathophysiological mechanisms underlying ventilation-induced changes of echocardiographic parameters used to determine diastolic LV function have never been thoroughly evaluated. Assessing diastolic function during MV is complex since Doppler derived surrogate parameters all depend on cardiac loading conditions and loading itself is inevitably coupled to MV. The question therefore arises whether echocardiography allows for detection of deteriorating LV diastolic function in terms of impaired intrinsic ventricular relaxation or LV stiffness or whether it primarily mirrors MV-induced loading alterations. It is important to differentiate if echocardiographic signs of diastolic dysfunction in the patient under MV are caused by changes in loading or a LV filling restraint since in case of hemodynamic instability the two scenarios would ask for different therapeutic measures. In case of a loading problem, pre- and afterload can be targeted using drugs or fluid resuscitation. If a MV-induced filling restraint is the predominant problem one may consider special ventilatory modes or even deep sedation and the use of muscle relaxants to minimize Pit.
The basic concepts of heart-lung interactions under positive pressure ventilation make it conceivable that extrinsic pressure applied to the thorax and therefore, as explained later in more detail, to the heart may mimic diastolic dysfunction even in a totally healthy heart if assessed by echocardiography. Echocardiographic parameters to assess diastolic function have been evaluated against the gold standard - invasive LV pressure and volume measurements - in spontaneously breathing patients. Such an evaluation is lacking for the patient with ventilatory support and therefore the value of echocardiography for assessment of diastolic function under MV needs further clarification. The investigators intend to comparatively study cardiac and particularly left ventricular diastolic function in ventilated patients using both invasive and ultrasound methods.
Objective
The presented study will elucidate the influence of positive pressure ventilation on cardiac function in humans. Furthermore, the investigators aim to describe the changes of echocardiographic parameters under different levels of positive pressure ventilation and link these changes to the underlying pathophysiological alterations in hemodynamics induced by positive pressure ventilation.
Methods
Prospective single-centre study at the University Hospital Berne. 30 patients scheduled for an elective coronary angiogram will be included. During spontaneous breathing and two different levels of non-invasive PPV transthoracic echocardiography is performed while recording LV-pressure-volume loops using an impedance catheter. Simultaneously the pulmonary artery occlusion pressure, the right atrial pressure and the intrathoracic pressure are recorded using a pulmonary artery catheter and an oesophageal balloon respectively.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Experimental | Other: Non-invasive positive pressure ventilationVentilatory support to alter intrathoracic pressure |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 to ≤ 75 years
- Indication for a coronary angiogram
- Written informed consent obtained
- Adequate echocardiographic imaging quality
- • Patient tolerates a face mask for non-invasive ventilation
Key exclusion criteria (13 listed)
- Acute coronary syndrome
- Previous myocardial infarction or open heart surgery
- Severe obstructive or restrictive pulmonary disease
- Pulmonary hypertension
- Diastolic dysfunction ≥ grade II
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 |
|---|---|---|
| Non-invasive positive pressure ventilationVentilatory support to alter intrathoracic pressure | Other | All patients |
Primary outcome
Left ventricular diastolic function
Time frame: Under spontaneous breathing and at two levels of positive pressure ventilation, 5 minutes after changing positive end-expiratory pressure
Assessed by pressure volume loops
3 secondary outcomes
Left ventricular contractility
Time frame: Under spontaneous breathing and at two levels of positive pressure ventilation, 5 minutes after changing positive end-expiratory pressure
Cardiac function
Time frame: Under spontaneous breathing and at two levels of positive pressure ventilation, 5 minutes after changing positive end-expiratory pressure
Invasively measured alterations in hemodynamics
Time frame: Under spontaneous breathing and at two levels of positive pressure ventilation, 5 minutes after changing positive end-expiratory pressure
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 30 Oct 2018.
- Derived from this study: PubMed 35381904Berger D, Wigger O, de Marchi S, Grubler MR, Bloch A, Kurmann R, Stalder O, Bachmann KF, Bloechlinger S. The effects of positive end-expiratory pressure on cardiac function: a comparative echocardiography-conductance catheter study. Clin Res Cardiol. 2022 Jun;111(6):705-719. doi: 10.1007/s00392-022-02014-1. Epub 2022 Apr 6.
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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.
Stefan Blöchlinger, MD, PhD principal investigator
Department of Cardiology, University Hospital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive positive pressure ventilation in people with Heart Function Tests and Hemodynamics, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 5 inclusion and 13 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 30 Oct 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 Switzerland. 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?
Left ventricular diastolic function (time frame: Under spontaneous breathing and at two levels of positive pressure ventilation, 5 minutes after changing positive end-expiratory pressure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02267291, which also lists 1 linked publication.
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 30 Oct 2018.