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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hypnosis + NIV, NIV.
- Who it may be relevant to
- Registry conditions: Chronic Obstructive Pulmonary Disease (COPD), Obesity With a BMI Greater Than 30, Acute Respiratory Distress in Adult Intensive Care. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
HYVIR : Interest of Hypnosis During the Implementation of Non-invasive Ventilation in a Patient With COPD and/or Obesity With a BMI Greater Than 30, Conscious With Acute Respiratory Distress in the Adult Intensive Care Unit
Overview
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.
Interventions
- Other 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. - 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 orde
Primary outcome measures
- Comfort [Time frame: 2 hours after initiation of NIV]
Secondary outcome measures (10)
- Anxiety [Time frame: Before and 30 minuts, 2 hours and 24 hours after the implementation of the NIV]
- First NIV session duration [Time frame: At the end of the first NIV session]
- Comfort [Time frame: Before and 30 minuts and 24 hours after the implementation of the NIV]
- TcpCO2 [Time frame: Before and 30 minuts, 2 hours and 24 hours after the implementation of the NIV]
- NIV duration [Time frame: after the first 24 hours of treatment]
- dyspnea [Time frame: 2 hours after the setting up of the NIV]
- Intubation [Time frame: Day 28]
- Stay duration [Time frame: Day 28]
- anxiolytic treatment prescription [Time frame: Day 28]
- stress [Time frame: Before and 30 minuts and 2 hours after the implementation of the NIV]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
France · 1 center
- Rennes University Hospital — Rennes
Identifiers
NCT: NCT04220463 · 35RC19_9747_HYVIR · 2019-A02238-49 · 19/08/14/42258