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
| NCT ID | NCT04220463 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rennes University Hospital |
| Condition | Chronic Obstructive Pulmonary Disease (COPD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2021-11-20 |
| Primary Completion | 2025-11-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2021-11-20 with a primary completion date of 2025-11-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Frequently Asked Questions
Who can join the NCT04220463 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Obstructive Pulmonary Disease (COPD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04220463 currently recruiting?
Yes, NCT04220463 is actively recruiting participants. Visit ClinicalTrials.gov or contact Rennes University Hospital to inquire about joining.
Where is the NCT04220463 trial being conducted?
This trial is being conducted at Rennes, France.
Who is sponsoring the NCT04220463 clinical trial?
NCT04220463 is sponsored by Rennes University Hospital. The trial plans to enroll 50 participants.
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