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

NCT04815317 | Completed

• 1 other identifier: 2019-A01532-55
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Detection and quantification of dyspnea intensity change

  Dyspnea will initially be searched for with absence or presence. If present, it will then be quantified using a visual analog scale graduated from 0 ("absence of respiratory discomfort") to 10 ("maximum respiratory discomfort").

  At the baseline and during the interventions

Secondary Outcomes (3)

• Anxiety

  At the baseline and during the interventions

• Mesure of pain

  At the baseline and during the interventions

• Electromyogram of extra-diaphragmatic inspiratory muscles

  At the baseline and during the interventions

Study Arms (2)

Basal

ACTIVE COMPARATOR

The impact of these stimulations will be compared to that of a control stimulus. 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. The sensitive control condition will be achieved by administering fresh air on the calf. An pressure support (+5) increment will be performed to ensure comparability of subsequent experimental sequences and their effect on dyspnea.

Other: Auditory control; Other: Sensitive control

Intervention

EXPERIMENTAL

Patients will be subjected to sensory stimuli that may be auditory or sensitive. The sensory stimulations will be administered by a research nurse. 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. 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: Auditive stimulation; Other: Sensitive stimulation

Interventions

Auditive stimulation OTHER

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.

Intervention

Sensitive stimulation OTHER

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.

Intervention

Auditory control OTHER

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.

Basal

Sensitive control OTHER

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

Basal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mechanical ventilation : invasive for at least 48 hours or non-invasive for at least 24 hours, sequential or continuous
• Dyspnea ≥ 4 on a visual analogic scale (VAS) from 0 to 10
• Absence of delirium (evaluated by the CAM-ICU score) ;
• Communicative patient

You may not qualify if:

• Patients on ECMO or decarboxylation ;
• Patients on long-term left ventricular support;
• Patients postoperatively following any surgery (pain from the procedure may interfere with dyspnea);
• Protected minors and adults;
• Pregnant women.

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, 75013, France

Location

Related Publications (5)

• Parshall MB, Schwartzstein RM, Adams L, Banzett RB, Manning HL, Bourbeau J, Calverley PM, Gift AG, Harver A, Lareau SC, Mahler DA, Meek PM, O'Donnell DE; American Thoracic Society Committee on Dyspnea. An official American Thoracic Society statement: update on the mechanisms, assessment, and management of dyspnea. Am J Respir Crit Care Med. 2012 Feb 15;185(4):435-52. doi: 10.1164/rccm.201111-2042ST.

  PMID: 22336677 BACKGROUND

• Morelot-Panzini C, Demoule A, Straus C, Zelter M, Derenne JP, Willer JC, Similowski T. Dyspnea as a noxious sensation: inspiratory threshold loading may trigger diffuse noxious inhibitory controls in humans. J Neurophysiol. 2007 Feb;97(2):1396-404. doi: 10.1152/jn.00116.2006. Epub 2006 Jul 26.

  PMID: 16870842 BACKGROUND

• Schmidt M, Demoule A, Polito A, Porchet R, Aboab J, Siami S, Morelot-Panzini C, Similowski T, Sharshar T. Dyspnea in mechanically ventilated critically ill patients. Crit Care Med. 2011 Sep;39(9):2059-65. doi: 10.1097/CCM.0b013e31821e8779.

  PMID: 21572329 BACKGROUND

• Abernethy AP, Currow DC, Frith P, Fazekas BS, McHugh A, Bui C. Randomised, double blind, placebo controlled crossover trial of sustained release morphine for the management of refractory dyspnoea. BMJ. 2003 Sep 6;327(7414):523-8. doi: 10.1136/bmj.327.7414.523.

  PMID: 12958109 BACKGROUND

• Lansing RW, Gracely RH, Banzett RB. The multiple dimensions of dyspnea: review and hypotheses. Respir Physiol Neurobiol. 2009 May 30;167(1):53-60. doi: 10.1016/j.resp.2008.07.012. Epub 2008 Jul 25.

  PMID: 18706531 BACKGROUND

MeSH Terms

Conditions

Dyspnea

Interventions

Sensitive Tartar Control Dentifrice

Condition Hierarchy (Ancestors)

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

Study Officials

• Alexandre DEMOULE, MD, PhD

  Groupe Hospitalier Universitaire APHP - Sorbonne Université Site Pitié-Salpêtrière (bâtiment Eole)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: March 25, 2021
• Study Start: November 26, 2019
• Primary Completion: August 27, 2021
• Study Completion: November 26, 2021
• Last Updated: September 2, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)