Impact of Proportional Assisted Ventilation on Dyspnea and Asynchrony in Mechanically Ventilated … (NCT02801994) | Clinical Trial Compass
CompletedNot Applicable
Impact of Proportional Assisted Ventilation on Dyspnea and Asynchrony in Mechanically Ventilated Patients
France34 participantsStarted 2016-02-24
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
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Inclusion Criteria:
Patients will be included as soon as the meet the following criteria.
* Intubation and mechanical ventilation for a respiratory cause with severe hypoxemia defined as a PaO2 to FiO2 ratio \<300 recorded at least once during the present ICU stay.
* PSV ventilation for \> 6 hours.
* Severe patient-ventilator disharmony defined by either
* a dyspnea ≥ 4 on a visual analogic scale (VAS) from 0 to 10 with respiratory rate ≥ 24 /minute and a drawing of neck muscles,
* or by an asynchrony index (IA) ≥ 10%, defined as = number of asynchrony events/total respiratory rate (ventilator cycles +wasted efforts) × 100
* No improvement of disharmony despite an optimization of ventilator setting defined as follows.
* No improvement of dyspnea or double triggering despite an increase of the level of pressure support that should not generate a tidal volume \> 10 ml/kg
* No improvement of ineffective efforts despite a decrease of the level of pressure support or generation of a dyspnea (defined as VAS\>4) in response of the decrease of the level of pressure support.
* Decision of the physician in charge of the patient to switch mechanical ventilation from PSV mode to PAV.
* Remaining duration of mechanical ventilation estimated ≥ 24 hours.
* Patient able to communicate (Richmond Agitation and Sedation Scale between -1 and +1).
Exclusion Criteria:
* Exclusion criteria will be as follows.
* Severe hypoxemia defined as a PaO2 to FiO2 ratio \<150 mmHg.
* Deliri…
Questions worth asking your doctor
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1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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Questions for the trial coordinator
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1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Quantification of dyspnea
Timeframe: in real time, during the procedure
Trial details
NCT IDNCT02801994
SponsorAssociation pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil