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Ventilator Hyperinflation and Hemodynamics

Not Applicable
Completed
Conditions
Respiratory Disorders
Respiratory Failure
Registration Number
NCT03557645
Lead Sponsor
Centro Universitário Augusto Motta
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
17
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Primary Outcome Measures
NameTimeMethod
Change in Cardiac OutputBaseline (before) and 10 minutes after the onset of VHI modesBasel

Estimation of cardiac output variation using thoracic bioimpedance

Secondary Outcome Measures
NameTimeMethod
Change in Systolic Volume IIBaseline (before) and 5 minutes after the end of VHI modes

Estimation of systolic volume variation using thoracic bioimpedance

Change in Vascular pulmonary resistanceBaseline (before) and 10 minutes after the onset of VHI modes

Estimation of vascular pulmonary resistance variation using thoracic bioimpedance

Change in Mean Arterial PressureBaseline (before) and 10 minutes after the onset of VHI modes

Recording of mean arterial pressure variation using an automatic noninvasive device

Change in Cardiac Index IIBaseline (before) and 5 minutes after the end of VHI modes

Estimation of cardiac index variation using thoracic bioimpedance

Change in Vascular pulmonary resistance IIBaseline (before) and 5 minutes after the end of VHI modes

Estimation of vascular pulmonary resistance variation using thoracic bioimpedance

Change in Mean Arterial Pressure IIBaseline (before) and 5 minutes after the end of VHI modes

Recording of mean arterial pressure variation using an automatic noninvasive device

Change in Cardiac IndexBaseline (before) and 10 minutes after the onset of VHI modes

Estimation of cardiac index variation using thoracic bioimpedance

Change in Systolic VolumeBaseline (before) and 10 minutes after the onset of VHI modes

Estimation of systolic volume variation using thoracic bioimpedance

Change in Cardiac Output IIBaseline (before) and 5 minutes after the end of VHI modes

Estimation of cardiac output variation using thoracic bioimpedance

Trial Locations

Locations (1)

Hospital Santa Martha

🇧🇷

Niterói, Rio De Janeiro, Brazil

Hospital Santa Martha
🇧🇷Niterói, Rio De Janeiro, Brazil

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