Clinical trial NCT04220463: 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Obesity With a BMI Greater Than 30
Acute Respiratory Distress in Adult Intensive Care
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2020-01-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective monocentric, controlled, randomized, superiority, open study with a blind assessor, on two parallel groups.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


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

Primary outcomes:
measure: Comfort
timeFrame: 2 hours after initiation of NIV
Secondary outcomes:
measure: Anxiety
timeFrame: Before and 30 minuts, 2 hours and 24 hours after the implementation of the NIV
measure: First NIV session duration
timeFrame: At the end of the first NIV session
measure: Comfort
timeFrame: Before and 30 minuts and 24 hours after the implementation of the NIV
measure: TcpCO2
timeFrame: Before and 30 minuts, 2 hours and 24 hours after the implementation of the NIV
measure: NIV duration
timeFrame: after the first 24 hours of treatment
measure: dyspnea
timeFrame: 2 hours after the setting up of the NIV
measure: Intubation
timeFrame: Day 28
measure: Stay duration
timeFrame: Day 28
measure: anxiolytic treatment prescription
timeFrame: Day 28
measure: stress
timeFrame: Before and 30 minuts and 2 hours after the implementation of the NIV
Other outcomes:
Locations:
city: Rennes
country: France
facility: Rennes University Hospital
state: Bretagne
Study officials:
References: