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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-20

Study Completion Date

2025-11-20

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective monocentric, controlled, randomized, superiority, open study with a blind assessor, on two parallel groups.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Patient randomization will be done online.

SETTING UP AND MAINTAINING THE INSU People having knowledge of the randomization group

* Doctor in charge of the patient
* Doctor/IDE dedicated to hypnosis (present throughout the procedure, regardless of the randomization group)
* Patient People not having knowledge of the randomization group
* assessor = other IDE or doctor not directly taking care of the patient assessor present at 4 times: inclusion, H0, H2 and H24 but absent during the procedure 1 single assessor for the 4 times of the same patient

Study Groups

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Hypnosis group

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.

Group Type EXPERIMENTAL

Hypnosis + NIV

Intervention Type 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.

Control group

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.

Group Type PLACEBO_COMPARATOR

NIV

Intervention Type 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.

Interventions

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Hypnosis + NIV

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.

Intervention Type OTHER

NIV

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.

Intervention Type OTHER

Eligibility Criteria

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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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No