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

NCT02801994 | Completed

• 1 other identifier: ADOREPS_1
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dyspnea

Keywords

Patient-ventilator interaction; Inspiratory muscles; Electromyogram; Mechanical ventilation; Proportional Assist Ventilation

Outcome Measures

Primary Outcomes (1)

• Quantification of dyspnea

  Dyspnea will be quantified with with the ICU Respiratory Distress Operating Scale (IC-RDOS)

  in real time, during the procedure

Secondary Outcomes (7)

• Airway pressure

  in real time, during the procedure

• Electromyography (EMG) of extra inspiratory diaphragmatic muscles

  in real time, during the procedure

• Electroencephalogram (EEG) in search of a pre-inspiratory potential

  in real time, during the procedure

• Arterial blood gas

  in real time, during the procedure

• Patient-ventilator asynchrony

  in real time, during the procedure

Study Arms (1)

Ventilator settings, PAV

EXPERIMENTAL

A first 30-minutes recording in PSV will be performed. Dyspnea-VAS, IC-RDOS will be measured at the beginning and at the end of this period. EMG and EEG will be recorded continuously. Patients will be subsequently switched to PAV. 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.

Device: PAV, Puritan Bennett 980 ventilator

Interventions

PAV, Puritan Bennett 980 ventilator DEVICE

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.

Ventilator settings, PAV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Severe hypoxemia defined as a PaO2 to FiO2 ratio \<150 mmHg.
• Delirium according to the CAM-ICU (1)
• Hemodynamic instability defined by the need for intravenous fluids or catecholamine during the previous 24 hours.
• Age \<18 years; pregnant woman.

Sponsors & Collaborators

• Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil: lead

Study Sites (1)

Service de Pneumologie et Réanimation Médicale, Groupe Hospitalier Pitié Salpêtrière

Paris, 75013, France

Location

Related Publications (43)

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MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2016
• First Posted: June 16, 2016
• Study Start: February 24, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: July 14, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)