Clinical trial NCT03640455: Randomized Study Evaluating the Efficacy of Low Intensity Transcranial Electrical Stimulation (Tdcs) for the Relief of Dyspnea
Official title: Etude Pilote Randomisee Versus Placebo Evaluant l'Efficacite de la Stimulation Electrique Transcranienne de Faible Intensite (Tdcs) Dans le Soulagement de la Dyspnee Chez Les Patients Sous Ventilation Mecanique en Reanimation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Dyspnea
Mechanical Ventilation Complication
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2018-08-21
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Nearly half (47%) of patients with mechanical ventilation in the intensive care unit report having dyspnea. This respiratory distress, with a feeling of "thirst for air", often reaches unbearable limits and is a major factor in the deterioration of the quality of life and the prognosis of patients. Physiopathological mechanisms of dyspnea are beginning better understood and have analogies with those of pain. Like pain, dyspnea often persists despite appropriate treatment of the cause, because of perceptual dysfunction related to changes in cortical excitability and neuronal plasticity and requires specific treatments. Studies have shown that Transcranial Stimulation by low Current (tDCS) was able to modulate the perception of acute pain induced and chronic pain. The tDCS modulates the functioning of a whole set of brain structures including the anterior cingulate gyrus, the prefrontal cortex, the thalamus and the brain stem, some of which have an established role in the central integration of pain and dyspnea. The investigators have recently demonstrated that the application of tDCS on the primary cortical motor area reduces the excitability of the central neurological pathways dedicated to the respiratory muscles in healthy subjects. The investigators therefore hypothesize that tDCS could relieve dyspnea in intensive care. In this research project, the investigators propose to evaluate the efficiency of tDCS on dyspnea in patients admitted to intensive care unit, having sepsis and mechanically ventilated.


Eligibility criteria: Inclusion Criteria:

* Adult patient, hospitalized in intensive care unit, presenting a sepsis, having required a mechanical ventilation since at least 24h.
* Non-sedated or showing good wake up (Richmond Agitation-Sedation Scale score (RASS)\> -3 at inclusion (Sessler et al., 2002)) within 48 hours after cessation of sedation
* Patient able to answer by "yes" or "no" to simple questions
* Showing significant dyspnea (level ≥ 4) on the A1 sub-scale of the Multidimensional Dyspnea Profile (MPD-A1 ≥ 4).
* Signature of informed consent by the patient or his relative.

Exclusion Criteria:

* Patient under guardianship,
* Wake up delay, coma (GCS ≤ 8), or severe agitation.
* chronic respiratory pathology
* respiratory pathology, neuromuscular or neuro-sensory disability (auditory or visual).
* Cranioplasty
* Language barrier, refusal to participate in the study or to sign the informed consent,
* Pregnant or nursing woman,
* No affiliation to a social security scheme.

Primary outcomes:
measure: Differential of the Dyspnea
timeFrame: 30 min
Secondary outcomes:
measure: Differential of the QS
timeFrame: 30 min
measure: Differential of the A2 dimension
timeFrame: 30 min
measure: Differential of IC-RDOS
timeFrame: 30 min
measure: Pre-inspiratory potentials (PIP)
timeFrame: 1 day
measure: Death
timeFrame: 28 days
measure: Delirium
timeFrame: 28 days
measure: Mechanical ventilation
timeFrame: 28 days
measure: ICU length of stay
timeFrame: 28 days
Other outcomes:
measure: mouth pressure
timeFrame: 30 min
measure: respiratory rate
timeFrame: 30 min
measure: tidal volume
timeFrame: 30 min
Locations:
city: Garches
country: France
facility: Hôpital Raymond Poincaré
Study officials:
References:
citation: Azabou E, Bao G, Heming N, Bounab R, Moine P, Chevallier S, Chevret S, Resche-Rigon M, Siami S, Sharshar T, Lofaso F, Annane D. Randomized Controlled Study Evaluating Efficiency of Low Intensity Transcranial Direct Current Stimulation (tDCS) for Dyspnea Relief in Mechanically Ventilated COVID-19 Patients in ICU: The tDCS-DYSP-COVID Protocol. Front Med (Lausanne). 2020 Jun 26;7:372. doi: 10.3389/fmed.2020.00372. eCollection 2020.