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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in Switzerland

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.

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 groups in NCT02267291
Study groupRoleWhat they receive
All patientsExperimentalVentilatory 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.

  1. 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)
  1. 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

  2. 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

  3. 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.

  1. First posted17 Oct 2014 (estimated)
  2. Study startJun 2015
  3. Primary completionFeb 2018
  4. Study completionFeb 2018

Resources

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)
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

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.

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