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 (HYVIR)

Rennes University Hospital

Status: Enrolling

Conditions: Obesity With a BMI Greater Than 30; Acute Respiratory Distress in Adult Intensive Care; Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Other: NIV; Other: Hypnosis + NIV

Study type: Interventional

Funder types: Other

Identifiers

NCT04220463

19/08/14/42258 (Other Identifier)

2019-A02238-49 (Other Identifier)

35RC19_9747_HYVIR

Details and patient eligibility

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups, including a placebo group

Hypnosis group

Experimental group

Description:

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.

Treatment:

Other: Hypnosis + NIV

Control group

Placebo Comparator group

Description:

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.

Treatment:

Other: NIV