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Impact of Non-invasive Positive Pressure Ventilation on Cardiac Function and Echocardiographic Parameters

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ClinicalTrials.gov Identifier: NCT02267291
Recruitment Status : Recruiting
First Posted : October 17, 2014
Last Update Posted : October 3, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief 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 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.

Condition or disease Intervention/treatment Phase
Heart Function Tests Hemodynamics Noninvasive Ventilation Circulatory and Respiratory Physiological Phenomena Other: Non-invasive positive pressure ventilation Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Impact of Non-invasive Positive Pressure Ventilation on Cardiac Function and Echocardiographic Parameters
Actual Study Start Date : June 2015
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : June 1, 2018

Arm Intervention/treatment
Experimental: All patients
Ventilatory support to alter intrathoracic pressure
Other: Non-invasive positive pressure ventilation
Ventilatory support to alter intrathoracic pressure




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Left ventricular contractility [ 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

  2. Cardiac function [ Time Frame: Under spontaneous breathing and at two levels of positive pressure ventilation, 5 minutes after changing positive end-expiratory pressure ]
    Assessed by echocardiography

  3. 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 ]
    Alterations of invasively measured hemodynamic parameters including cardiac output and pulmonary artery, right ventricular and right atrial pressures



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria

  • 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
  • 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

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): NCT02267291


Locations
Switzerland
Department of Cardiology, Bern University Hospital Recruiting
Bern, BE, Switzerland, 3010
Contact: Stefan Blöchlinger, MD, PhD    +41 31 632 83 47    stefan.bloechlinger@insel.ch   
Contact: David Berger, MD    +41 31 632 50 79    david.berger@insel.ch   
Principal Investigator: Stefan Blöchlinger, MD         
Sub-Investigator: David Berger, MD         
Sub-Investigator: Tobias Merz, MD         
Sub-Investigator: Björn Zante, MD         
Sub-Investigator: Andreas Bloch, MD         
Sub-Investigator: Olivier Wigger, MD         
Sub-Investigator: Stefano de Marchi, MD         
Sub-Investigator: Thomas Pilgrim, MD         
Sub-Investigator: Stephan Windecker, MD         
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Principal Investigator: Stefan Blöchlinger, MD, PhD Department of Cardiology, University Hospital Bern

Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT02267291     History of Changes
Other Study ID Numbers: 104/14
First Posted: October 17, 2014    Key Record Dates
Last Update Posted: October 3, 2017
Last Verified: October 2017

Keywords provided by University Hospital Inselspital, Berne:
Cardiac Catheterization
Echocardiography
Noninvasive Ventilation
Positive-Pressure Respiration
Ventricular Function