Sensory and Emotional Modulation of Dyspnea Under Artificial Ventilation in the Intensive Care Unit

Summary

Rationale: Half of the patients receiving mechanical ventilation in the intensive care unit (ICU) have moderate to severe dyspnea. This dyspnea has a negative impact on the duration of mechanical ventilation, on patients' comfort and could be involved in the genesis of post-traumatic stress syndromes, a frequent complication of intensive care. Modifying ventilation parameters does not always relieve dyspnea and administering morphine prolongs the duration of mechanical ventilation. Dyspnea has, in addition to its sensory component, an emotional component. The possibility to distract the patients' attention or to modulate their emotions in order to relieve their dyspnea could therefore represent an innovative therapeutic alternative devoid of side effects.

Objectives: To evaluate the effect of auditory and sensory extra respiratory stimuli on the sensation of dyspnea in intensive care patients undergoing mechanical, invasive or non-invasive ventilation.

Methods: 45 intensive care patients under artificial ventilation will be exposed, according to their randomization arm, to the following two stimuli for a duration of 10 minutes:

* standard relaxing music piece versus "pink" noise;
* fresh air on the face versus fresh air on the thigh. The effect of this stimulus will be compared to a randomized control, these two conditions will be separated by a wash-out period.

An pressure support (+5) increment will be performed to ensure comparability of subsequent experimental sequences and their effect on dyspnea.

Dyspnea will be assessed in terms of intensity (visual analog scale) and characterized sensorially. Will also be evaluated during the different conditions: pain, anxiety and stress (sympathetic/parasympathetic balance) and extra-diaphragmatic electromyographic activity.

Ethical framework: research involving the human person at risk and minimal constraints (physiology study that does not entail any risk for the patients).

Expected results and prospects: the investigators hypothesize that pleasant extra-respiratory sensory stimulation significantly reduces the intensity of dyspnea in artificially ventilated patients without any change in ventilator settings and pharmacological intervention. This reduction in dyspnea is associated with decreased anxiety and stress levels.

This study will bring new, easy-to-use and side-effect-free tools to the therapeutic arsenal for the relief of dyspnea in mechanically ventilated patients.

Conditions

• Dyspnea

Interventions

OTHER

Auditive stimulation

The auditory stimulation will consist of listening to relaxing pieces of music from MP3 files from the International Center for Music Therapy (Noisy le Grand, France). Listening will be done through noise-cancelling headphones (PLANTRONICS, Gamecom 780, Santa Cruz, California, USA) for 10 minutes.

OTHER

Sensitive stimulation

Sensitive stimulation will consist of administering fresh air to the patient's face by means of a fan without blades (DYSON AM01, Malmesbury, UK) for 10 minutes.

OTHER

Auditory control

The auditory control condition will consist of listening to a pink noise. The pink noise, like the white noise, is a normalized noise. The sound produced on a TV set that is out of adjustment during the "snow effect" is a representative example of such noise. Pink noise is a random signal whose power spectral density decreases by 3dB per octave. This signal is closer to the sensitivity of the ear than white noise.

OTHER

Sensitive control

The sensitive control condition will be achieved by administering fresh air on the calf.

Sponsors & Collaborators

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

  lead OTHER

Principal Investigators

• Alexandre DEMOULE, MD, PhD · Groupe Hospitalier Universitaire APHP - Sorbonne Université Site Pitié-Salpêtrière (bâtiment Eole)

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-11-26

Primary Completion

2021-08-27

Completion

2021-11-26

Countries

• France

Study Locations