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Validation of an Observational Scale of Dyspnea in Non-communicating Patients in the ICU (DYS-NOC)

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ClinicalTrials.gov Identifier: NCT02801838
Recruitment Status : Completed
First Posted : June 16, 2016
Last Update Posted : August 1, 2017
Sponsor:
Information provided by (Responsible Party):
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

Brief Summary:

Background : Dyspnea is common and severely impact mechanically ventilated patients outcomes in intensive care unit (ICU). Recognize, measure and treat dyspnea have become current major therapeutic challenge. Its measurement involves a self-assessment by the patient, and by definition, a certain level of communication. Consequently, a large proportion of the ICU-population (non-communicating) misses its evaluation and potential benefits associated with its control. In other hand, electrophysiological markers that help to detect and quantify dyspnea regardless of the patient's cooperation, has been developed and validated as dyspnea surrogate, namely: 1) the electromyographic (EMG) activity of extra diaphragmatic inspiratory muscles and 2) the premotor inspiratory potentials (PIP) detected on the electroencephalogram (EEG). Because of its complex implementation in daily practice the research team has developed alternatively a behavioral score called IC-RDOS that provides reliable dyspnea assessment also without patient participation. Validated in conscious patients, it has not been yet validated in non-communicating patients.

Hypothesis : The IC-RDOS is valid for non-communicating ventilated patients and allows a simple and reliable assessment of dyspnea in this specific population.

Objective : To validate the IC-RDOS in non-communicating ICU patients under mechanical ventilation, using comparison with the tools validated for reliable measure of dyspnea in non-communicating patients (EMG, EEG).

Patients and Methods: In 40 patients will be collected simultaneously IC-RDOS, PIP (EEG) and electromyographic activity of three extra diaphragmatic inspiratory muscles (scalene, parasternal and Alae nasi) before and after intervention therapy aiming at reduce dyspnea (ventilator settings or pharmacological intervention), initiated by the clinician in charge of the patient.

Expected results : Observe a strong positive correlation between the IC-RDOS and electrophysiological markers (amplitude of the electromyogram and presence and magnitude of PIP). Observe a correlation between changes in the IC-RDOS and the electrophysiological markers after therapeutic interventions.

Optimizing patient comfort is a prominent concern in the ICU. By optimizing the detection and quantification of dyspnea in non-communicating patients, this study should ultimately improve the management and "the better living" of ventilated patients in intensive care


Condition or disease Intervention/treatment Phase
Dyspnea Drug: Morphine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Feasibility and Validity of an Observational Scale as a Surrogate of Dyspnea in Non-communicating Patients in the Intensive Care Unit (ICU): DYS-NOC
Actual Study Start Date : February 23, 2016
Actual Primary Completion Date : February 23, 2017
Actual Study Completion Date : July 28, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ventilator settings, morphine titration
First, ventilator settings optimization and when the clinician judges necessary (remains discomfortable), opioid titration with a maximum of 10mg of morphine
Drug: Morphine
If the physician in charge of the patients judges it necessary, after the optimization of the ventilators settings, if the patient remains uncomfortable, a second therapeutic intervention using a maximum of 10mg morphine titration may be performed. After this second therapeutic intervention, a third non-verbal measure of respiratory discomfort will be performed with the IC-RDOS. Concomitantly, EEG and EMG will be again recorded over a of 15-minutes period.
Other Name: Morphine sulfate




Primary Outcome Measures :
  1. Respiratory comfort with IC-RDOS [ Time Frame: in real time, during the procedure ]

    Quantification of dyspnea:

    Dyspnea will be quantified with the ICU Respiratory distress operating scale.



Secondary Outcome Measures :
  1. EMG signals of extradiaphragmatic muscles [ Time Frame: in real time, during the procedure ]

    EMG signals will be collected using surface electrodes (Kendall, Tyco Healthcare, Germany).

    Bilateral para-sternal intercostal-target recordings will be obtained from the second intercostal space, close to the sternum. Bilateral scalene-targeted recordings will be obtained in the posterior triangle of the neck at the level of the cricoid cartilage. Alae nasi-targeted recordings will be obtained by placing one electrode on each nostril.

    A distance of 2 cm separates the electrode pairs. The impedance must remain below 2000 Ω. Cables connected to the electrodes will be fixed with adhesive tape to prevent the occurrence of artifacts related to the movement of the upper limbs. All these signals will be recorded at a sampling frequency of 1000 Hz (PowerLab, AD Instruments, Castle Hill, Australia).


  2. Airways flow [ Time Frame: in real time, during the procedure ]
    Airways flow will be measured with a pneumotachograph

  3. Airways pressure [ Time Frame: in real time, during the procedure ]
    The airway pressure will be measured at the Y-piece by means of a differential pressure transducer

  4. Pre-inspiratory potential at Electroencephalogram (EEG) [ Time Frame: in real time, during the procedure ]
    Electroencephalogram (EEG) will be recorded using 30 surface electrodes (EEG international 10-20 system) (Rektor, 2002). Surface electrodes associated with ear lobes will serve as reference.

  5. Arterial blood gas [ Time Frame: in real time, during the procedure ]
    For patients with an arterial catheter, a blood gas analysis will be performed using an arterial blood sample of a volume of less than 1ml.



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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 all the following criteria will be met.

  • Invasive mechanical ventilation for > 24 h.
  • All cycles triggered by the patient.
  • "Non-communicating" patient, defined as a score < -1 on the Richmond Agitation and Sedation Scale (RASS) [1].
  • Suspicion by the clinician in charge of the patient of a dyspnea by at least two of the four following elements: tachypnea > 25 cycles/min ; suprasternal or supraclavicular draw ; abdominal paradox on inspiration ; facial discomfort expression (facial rating scale).
  • Decision by the physician in charge of the patient to make an intervention in order to reduce dyspnea. This intervention will consist either in change in ventilator settings or in the administration of pharmacologic agents that reduce dyspnea, such as opioids.

Exclusion Criteria:

Exclusion criteria will be as follows.

  • Age < 18 years.
  • Pregnancy.
  • Severe acquired or congenital neuropathy or myopathy that could affect the physical or behavioural manifestations of dyspnea and the collection of EMG activity of inspiratory extra diaphragmatic muscles.
  • Central neurological disease that may alter the collection of PIP.

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): NCT02801838


Locations
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France
Service de Pneumologie et Réanimation Médicale, Groupe Hospitalier Pitié Salpêtrière Paris, France
Paris, France, 75020
Sponsors and Collaborators
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
Publications of Results:

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Responsible Party: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
ClinicalTrials.gov Identifier: NCT02801838    
Other Study ID Numbers: ADOREPS_2
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017
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:
Inspiratory muscles
Patient-ventilator interaction
Electromyogram
Mechanical ventilation
Additional relevant MeSH terms:
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Dyspnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents