Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Impact of Proportional Assisted Ventilation on Dyspnea and Asynchrony in Mechanically Ventilated Patients (DYS-PAV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02801994
Recruitment Status : Recruiting
First Posted : June 16, 2016
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

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.


Condition or disease Intervention/treatment Phase
Dyspnea Device: PAV, Puritan Bennett 980 ventilator Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Proportional Assisted Ventilation on Dyspnea and Asynchrony in Mechanically Ventilated Patients
Actual Study Start Date : February 24, 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ventilator settings, PAV

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
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.




Primary Outcome Measures :
  1. Quantification of dyspnea [ Time Frame: in real time, during the procedure ]
    Dyspnea will be quantified with with the ICU Respiratory Distress Operating Scale (IC-RDOS)


Secondary Outcome Measures :
  1. Airway pressure [ Time Frame: in real time, during the procedure ]
    The airway pressure will be also measured at the Y-piece by a differential pressure transducer (Validyne, Northridge, USA).

  2. Electromyography (EMG) of extra inspiratory diaphragmatic muscles [ Time Frame: in real time, during the procedure ]
    The amplitude of the EMG signal of extradiaphragmatics inspiratory muscles is proportional to the intensity of dyspnea. EMG will be collected by self-adhesive surface electrodes of the same type as those commonly used to collect the ECG signal in critically ill patients. A distance of 2 cm will separate the two electrodes. The position of the electrodes will depend on the recorded muscle.

  3. Electroencephalogram (EEG) in search of a pre-inspiratory potential [ Time Frame: in real time, during the procedure ]
    The application of an inspiratory resistive load to healthy subjects results in the activation of the pre-motor cortex detected by EEG recording. This EEG activity is named pre-inspiratory potential (PIP).

  4. Arterial blood gas [ Time Frame: in real time, during the procedure ]
    For patients with an arterial catheter, the measurement of blood gases using an arterial blood sample of a volume of less than 1ml be performed at the end of each condition.

  5. Patient-ventilator asynchrony [ Time Frame: in real time, during the procedure ]
    Asynchrony will be detected by visual inspection of the recordings. The investigators will investigate patterns of two major asynchronies that are easily detected on pressure and flow recordings: ineffective triggering and double triggering. Ineffective triggering will be defined as an abrupt airway pressure drop (≥ 0.5 cmH2O) simultaneous to a flow decrease (in absolute value) and not followed by an assisted cycle during the expiratory period. Double-triggering will be defined as two cycles separated by a very short expiratory time, defined as less than one-half of the mean inspiratory time, the first cycle being patient-triggered.

  6. Flow [ Time Frame: in real time, during the procedure ]
    Airway flow will be measured with a pneumotachograph (Hans Rudolph, Kansas City, USA) inserted between the Y-piece and the endotracheal tube and connected to a differential pressure sensor (Validyne, Northridge, USA).

  7. Quantification of dyspnea [ Time Frame: in real time, during the procedure ]
    Dyspnea will be quantified with a dyspnea-VAS from 0 (no discomfort) to 10 (maximum breathing)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
    • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02801994


Locations
Layout table for location information
France
Service de Pneumologie et Réanimation Médicale, Groupe Hospitalier Pitié Salpêtrière Recruiting
Paris, France, 75013
Contact: Alexandre Demoule, MD, PhD    +33142167761    alexandre.demoule@aphp.fr   
Contact: Côme Bureau, Resident    +33676037129    come.bureau@gmail.com   
Sponsors and Collaborators
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
Publications of Results:

Layout table for additonal information
Responsible Party: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
ClinicalTrials.gov Identifier: NCT02801994    
Other Study ID Numbers: ADOREPS_1
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil:
Patient-ventilator interaction
Inspiratory muscles
Electromyogram
Mechanical ventilation
Proportional Assist Ventilation
Additional relevant MeSH terms:
Layout table for MeSH terms
Dyspnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms