Validation of an Observational Scale of Dyspnea in Non-communicating Patients in the ICU

NCT02801838 | Completed

• 1 other identifier: ADOREPS_2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Dyspnea

Keywords

Inspiratory muscles; Patient-ventilator interaction; Electromyogram; Mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Respiratory comfort with IC-RDOS

  Quantification of dyspnea: Dyspnea will be quantified with the ICU Respiratory distress operating scale.

  in real time, during the procedure

Secondary Outcomes (5)

• EMG signals of extradiaphragmatic muscles

  in real time, during the procedure

• Airways flow

  in real time, during the procedure

• Airways pressure

  in real time, during the procedure

• Pre-inspiratory potential at Electroencephalogram (EEG)

  in real time, during the procedure

• Arterial blood gas

  in real time, during the procedure

Study Arms (1)

Ventilator settings, morphine titration

EXPERIMENTAL

First, ventilator settings optimization and when the clinician judges necessary (remains discomfortable), opioid titration with a maximum of 10mg of morphine

Drug: Morphine

Interventions

Morphine DRUG

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.

Also known as: Morphine sulfate

Ventilator settings, morphine titration

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 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.

You may not qualify if:

• 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.

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, France

Paris, 75020, France

Location

Related Publications (28)

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  PMID: 36973007 DERIVED

MeSH Terms

Conditions

Dyspnea

Interventions

Morphine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• 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 23, 2016
• Primary Completion: February 23, 2017
• Study Completion: July 28, 2017
• Last Updated: August 1, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)