Clinical trial

Interest of Hypnosis When Setting up Non-invasive Ventilation in a Conscious Patient With COPD and/or Obesity With a BMI Greater Than 30, Suffering Fromacute Respiratory Distress in Adult Intensive Care

Recruiting now · Not applicable · 1 countries · Registry ID NCT04220463

Recruiting nowNot applicableInterventional

What this study is about

Discomfort during respiratory decompensation of a patient with chronic obstructive pulmonary disease (COPD) and/or obesity with a BMI greater than 30, in intensive care and the establishment of non-invasive ventilation (NIV) is frequent and a source of failure. this therapy. Pharmacological treatments may be impossible due to the pathology, the risk of it worsening and adverse effects. In this context, hypnosis appears to be a tool that would promote comfort and thus increase tolerance of NIV.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionChronic Obstructive Pulmonary Disease (COPD), Obesity With a BMI Greater Than 30, Acute Respiratory Distress in Adult Intensive Care

Full registry criteria

Pre-inclusion criteria * Man or woman, aged 18 or over, admitted to medical intensive care * Glasgow score = 15 * Patient with acute respiratory failure decompensating COPD and/or having obesity with a body mass index (BMI) greater than 30 * Patient having given free, informed and written consent * Patient affiliated to a health insurance system Inclusion Criteria: * Glasgow score = 15 * Need during use of non-invasive ventilation Exclusion Criteria: * Procedure to be carried out in extreme urgency (PaCO2 too high and leading to an immediate vital risk, and / or PaO2 too low) on medical decision * Confusional state making hypnosis impossible * Decompensated psychiatric illness * Patient entering with an NIV in place already installed in another department. The subject becomes included again at the end of the treatment with NIV if however he needs it again. * Patient already included in the study during previous non-invasive ventilation * Patient participating in research involving an interventional human person (category 1) on an analgesic / sedative medication * A person of full age subject to legal protection (safeguard of justice, curators, guardianship) or deprived of liberty

Treatments and study arms

Hypnosis + NIV

Other

For the hypnosis group, hypnotic support is set up by a doctor/IDE previously trained and dedicated during the implementation of the NIV. The dedicated doctor/IDE will be presented before the start of the NIV setup procedure and will start the hypnosis session a few minutes before the mask is put on. The procedure for setting up the NAV may begin after agreement from the dedicated doctor/IDE.

NIV

Other

In the control group, in order to preserve the knowledge of the evaluator, the doctor/IDE dedicated to hypnosis is present in the service but does not intervene in the care so as not to be tempted to involuntarily put hypnosis in place. The assessor will be chosen from the two other teams present in the other two modules (each module is a seven-bed unit and has no physical communication with the other two) after the start of the procedure for setting up the NIV, with or without hypnosis, in order to be certain that he had no visual contact with the patient and the caregivers present before the evaluation. The implementation of the NAV will take place as usually carried out in the service.

Primary outcomes

Comfort2 hours after initiation of NIV

Quantification of comfort by a Digital Verbal Comfort Scale 2 hours after initiation of NIV (from 0 to 10, 0 being the minimum comfort felt and 10 the maximum comfort felt by the patient)

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Rennes University Hospital🇫🇷 Rennes, Brittany Region, France

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Claude Faleur, nurseContact

Email · Call 0299284321

Violaine BENOIT, project leaderContact

Email · Call 0299289741

Claude Faleur, nursePrincipal Investigator