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Clinical Trials/NCT03557645
NCT03557645
Completed
Not Applicable

Hemodynamic Repercussions of Ventilator Hyperinflation Using Volume-controlled Ventilation: a Randomized Controlled Trial

Centro Universitário Augusto Motta1 site in 1 country17 target enrollmentNovember 5, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Failure
Sponsor
Centro Universitário Augusto Motta
Enrollment
17
Locations
1
Primary Endpoint
Change in Cardiac Output
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Ventilator hyperinflation (VHI) has been shown to be effective in improving respiratory mechanics, secretion removal, and gas exchange in mechanically ventilated patients; however, the literature is scarce concerning its safety and adverse effects. Thus, the aim of this study is to compare the hemodynamic repercussions of VHI in volume-controlled mode. In a randomized, controlled and crossover design, 24 mechanically ventilated patients will undergo 2 modes of ventilator hyperinflation (with and without an inspiratory pause) and a control intervention. Cardiac output, cardiac index, mean arterial pressure, pulmonary vascular resistance, systolic volume and other hemodynamic variables will be recorded during the interventions.

Detailed Description

Background: ventilator hyperinflation (VHI) has been shown to be effective in improving respiratory mechanics, secretion removal, and gas exchange in mechanically ventilated patients; however, the literature is scarce concerning its safety and adverse effects. Thus, the aim of this study is to compare the hemodynamic repercussions of VHI in volume-controlled mode. Methods: in a randomized, controlled and crossover design, 24 mechanically ventilated patients will undergo 2 modes of ventilator hyperinflation (with and without an inspiratory pause of 2 seconds) and a control intervention. For the VHI interventions, the inspiratory flow will be set at 20 Lpm, and tidal volume will be increased until a peak pressure of 40cmH2O is achieved. During the control intervention, the patients will remain in volume-control ventilation with an inspiratory flow = 60Lpm and tidal volume = 6mL/IBW. The interval between interventions (washout) will be of 10 minutes or more, according to the time needed to recover the cardiac index to baseline values (maximum difference of 10%). Cardiac output, cardiac index, mean arterial pressure, pulmonary vascular resistance, systolic volume and other hemodynamic variables will be recorded during the interventions by using impedance cardiography.

Registry
clinicaltrials.gov
Start Date
November 5, 2017
End Date
September 30, 2018
Last Updated
5 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Centro Universitário Augusto Motta
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients under mechanical ventilation for more than 48h

Exclusion Criteria

  • mucus hypersecretion (defined as the need for suctioning \< 2-h intervals),
  • absence of respiratory drive,
  • atelectasis,
  • severe bronchospasm,
  • positive end expiratory pressure \> 10cmH2O,
  • PaO2-FiO2 relationship \< 150,
  • mean arterial pressure \< 60mmHg,
  • inotrope requirement equivalent to \>15 ml/h total of adrenaline and noradrenalin,
  • intracranial pressure \> 20mmHg

Outcomes

Primary Outcomes

Change in Cardiac Output

Time Frame: Baseline (before) and 10 minutes after the onset of VHI modesBasel

Estimation of cardiac output variation using thoracic bioimpedance

Secondary Outcomes

  • Change in Systolic Volume II(Baseline (before) and 5 minutes after the end of VHI modes)
  • Change in Vascular pulmonary resistance(Baseline (before) and 10 minutes after the onset of VHI modes)
  • Change in Mean Arterial Pressure(Baseline (before) and 10 minutes after the onset of VHI modes)
  • Change in Cardiac Index II(Baseline (before) and 5 minutes after the end of VHI modes)
  • Change in Vascular pulmonary resistance II(Baseline (before) and 5 minutes after the end of VHI modes)
  • Change in Mean Arterial Pressure II(Baseline (before) and 5 minutes after the end of VHI modes)
  • Change in Cardiac Index(Baseline (before) and 10 minutes after the onset of VHI modes)
  • Change in Systolic Volume(Baseline (before) and 10 minutes after the onset of VHI modes)
  • Change in Cardiac Output II(Baseline (before) and 5 minutes after the end of VHI modes)

Study Sites (1)

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