CompletedNot Applicable

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

France50 participantsStarted 2016-02-23

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

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

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

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

Respiratory comfort with IC-RDOS

Timeframe: in real time, during the procedure

Trial details

NCT IDNCT02801838

SponsorAssociation pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-02-23

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