Clinical trial NCT03557645: Ventilator Hyperinflation and Hemodynamics
Official title: Hemodynamic Repercussions of Ventilator Hyperinflation Using Volume-controlled Ventilation: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Respiratory Disorders
Keywords: mechanical ventilation
physiotherapy
ventilator hyperinflation
airway clearance technique
Lead sponsor: Centro Universitário Augusto Motta
Sponsor class: OTHER
Collaborators: name: Universidade Federal do Rio de Janeiro
First posted: 2018-06-15
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover Assignment
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Cardiac Output
timeFrame: Baseline (before) and 10 minutes after the onset of VHI modesBasel
Secondary outcomes:
measure: Change in Cardiac Index
timeFrame: Baseline (before) and 10 minutes after the onset of VHI modes
measure: Change in Vascular pulmonary resistance
timeFrame: Baseline (before) and 10 minutes after the onset of VHI modes
measure: Change in Systolic Volume
timeFrame: Baseline (before) and 10 minutes after the onset of VHI modes
measure: Change in Mean Arterial Pressure
timeFrame: Baseline (before) and 10 minutes after the onset of VHI modes
measure: Change in Cardiac Output II
timeFrame: Baseline (before) and 5 minutes after the end of VHI modes
measure: Change in Cardiac Index II
timeFrame: Baseline (before) and 5 minutes after the end of VHI modes
measure: Change in Vascular pulmonary resistance II
timeFrame: Baseline (before) and 5 minutes after the end of VHI modes
measure: Change in Systolic Volume II
timeFrame: Baseline (before) and 5 minutes after the end of VHI modes
measure: Change in Mean Arterial Pressure II
timeFrame: Baseline (before) and 5 minutes after the end of VHI modes
Other outcomes:
Locations:
city: Niterói
country: Brazil
facility: Hospital Santa Martha
state: Rio De Janeiro
Study officials:
affiliation: Centro Universitário Augusto Motta
name: Fernando Guimaraes, PhD
role: STUDY_CHAIR
References:
citation: Berney S, Denehy L. A comparison of the effects of manual and ventilator hyperinflation on static lung compliance and sputum production in intubated and ventilated intensive care patients. Physiother Res Int. 2002;7(2):100-8. doi: 10.1002/pri.246.
citation: Lemes DA, Zin WA, Guimaraes FS. Hyperinflation using pressure support ventilation improves secretion clearance and respiratory mechanics in ventilated patients with pulmonary infection: a randomised crossover trial. Aust J Physiother. 2009;55(4):249-54. doi: 10.1016/s0004-9514(09)70004-2.
citation: Anderson A, Alexanders J, Sinani C, Hayes S, Fogarty M. Effects of ventilator vs manual hyperinflation in adults receiving mechanical ventilation: a systematic review of randomised clinical trials. Physiotherapy. 2015 Jun;101(2):103-10. doi: 10.1016/j.physio.2014.07.006. Epub 2014 Oct 6.