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

NCT02267291 | Completed

• 1 other identifier: 104/14
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Function Tests; Hemodynamics; Noninvasive Ventilation; Circulatory and Respiratory Physiological Phenomena

Keywords

Cardiac Catheterization; Echocardiography; Noninvasive Ventilation; Positive-Pressure Respiration; Ventricular Function

Outcome Measures

Primary Outcomes (1)

• Left ventricular diastolic function

  Assessed by pressure volume loops

  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

  Under spontaneous breathing and at two levels of positive pressure ventilation, 5 minutes after changing positive end-expiratory pressure

• Cardiac function

  Under spontaneous breathing and at two levels of positive pressure ventilation, 5 minutes after changing positive end-expiratory pressure

• Invasively measured alterations in hemodynamics

  Under spontaneous breathing and at two levels of positive pressure ventilation, 5 minutes after changing positive end-expiratory pressure

Study Arms (1)

All patients

EXPERIMENTAL

Ventilatory support to alter intrathoracic pressure

Other: Non-invasive positive pressure ventilation

Interventions

Non-invasive positive pressure ventilation OTHER

Ventilatory support to alter intrathoracic pressure

All patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Department of Cardiology, Bern University Hospital

Bern, Canton of Bern, 3010, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 35381904 DERIVED

Study Officials

• Stefan Blöchlinger, MD, PhD

  Department of Cardiology, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2014
• First Posted: October 17, 2014
• Study Start: June 1, 2015
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: October 30, 2018

Record last verified: 2018-10

Locations

CH (1)