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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 sett

Detailed Summary:

INTRODUCTION

It becomes clear that dyspnea is becoming a major matter of concern in ICU mechanically ventilated patients. As this is the case for pain, addressing dyspnea in ICU patients therefore appears highly clinically relevant. This requires focused awareness from caregivers and patient cooperation. Indeed, because dyspnea involves the sensory identification of afferent signals by the brain and their cognitive and affective processing, its characterization depends on self-report. Clinical signs of "respiratory distress" and self-perceived dyspnea can be disconnected, setting a limitation to identifying dyspnea in many ICU patients whose ability to communicate verbally is impaired. Nevertheless, a link does exist between dyspnea and certain observable signs. A respiratory distress observation scale (RDOS) has been validated as a surrogate for self-reported dyspnea in the palliative care setting.

In ICU patients, the research team has recently developed and validated a 5-items intensive care (IC)-RDOS (heart rate, neck muscles use during inspiration, abdominal paradox, fear expression, supplemental oxygen). The findings validate IC-RDOS as potential surrogates of dyspnea in the ICU, proving the concept that observation scales can be useful in this context. Indeed, IC-RDOS had a high sensitivity and specificity to predict a dyspnea-VAS ≥4. However, IC-RDOS is only validated in aware patients and its clinical usefulness in "non communicating" patients still need to be demonstrated.

Addressing dyspnea in "non-communicating" patients is challenging since these patients cannot self-report dyspnea. However, it does not mean at all that they do not experience dyspnea. Indeed, "non-communicating" and "communicating" mechani
Sponsor: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le So

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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).

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

Original Secondary Outcome: Same as current

Information By: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le So

Dates:
Date Received: May 6, 2016
Date Started: February 2016
Date Completion: October 2017
Last Updated: February 15, 2017
Last Verified: January 2017