CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 34 enrolled
Drug / intervention
PAV, Puritan Bennett 980 ventilatordevice
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02801994
NCT02801994N/ACompleted

Impact of Proportional Assisted Ventilation on Dyspnea and Asynchrony in Mechanically Ventilated Patients

In Brief

A clinical study evaluating PAV, Puritan Bennett 980 ventilator for Dyspnea. Completed, enrolled 34 participants across 1 site.

Detailed Summary

Rational. The mismatch between the activity of the respiratory muscles and the assistance delivered by the ventilator results in patient-ventilator disharmony, which is commonly observed in ICU patients and is associated with dyspnea and patient-ventilator asynchrony. Both dyspnea and asynchrony are in turn associated with a worse prognosis. Unlike conventional modes of mechanical ventilation, such as pressure support ventilation (PSV) that deliver a constant level of assistance regardless of the patient effort, Proportional Assisted Ventilation (PAV) adjusts the level of ventilator assistance to the activity of respiratory muscles. To date, data on the impact of PAV on dyspnea and patient ventilator asynchrony are scarce and most studies have been conducted in healthy subjects or in ICU patients who had no severe dyspnea nor severe asynchrony. To our knowledge, there are no data in patients with severe patient-ventilator dysharmony. Study Aim. To evaluate the impact of PAV on dyspnea and patient-ventilator asynchrony in ICU mechanically ventilated patients in intensive care with severe patient-ventilator disharmony defined as either severe dyspnea or severe patient-ventilator asynchrony. Patients and Methods. Will be included 24 ICU mechanically ventilated patient exhibiting severe patient-ventilator dysharmony with PSV. The intensity of dyspnea will be assessed by the VAS, the ICRDOSS and by the electromyogram of extradiaphragmatic inspiratory muscles and pre inspiratory potential collected from the electroencephalogram. The prevalence of patient-ventilator asynchrony will be quantified. Expected results. It is anticipated that the switch from PSV to PAV will decrease the prevalence and severity of dyspnea and the prevalence of patient-ventilator asynchrony.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDyspnea
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 16, 2016
Enrollment StartFeb 24, 2016
Primary CompletionDec 31, 2017
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 10.0 years ago

Interventions

PAV, Puritan Bennett 980 ventilatordevice

The PAV mode will be delivered by Puritan Bennett 980 ventilator (Covidien, Boulder, USA). Levels of PEEP and FiO2 will be kept constant. The level of assistance in PAV, named %-assistance will be set in order to keep the patient in a respiratory effort zone corresponding to a respiratory muscles pressure time product (PTPmus) between 50 and 150 cm H2O • s / min. As it is not possible to calculate directly the PTPmus at bedside, the investigators will use as a substitute its main component, the pressure peak muscle of the airways according to the previous report from Carteaux et al. This setting has been described extensively and its use has been the subject of a feasibility study in 50 patients. After a 20-minutes stabilization period, a 30-minutes recording will be performed.