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Идёт набор 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

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

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Hypnosis + NIV, NIV.
Кому может быть актуально
Состояния в реестре: Chronic Obstructive Pulmonary Disease (COPD), Obesity With a BMI Greater Than 30, Acute Respiratory Distress in Adult Intensive Care. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
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Официальное название

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

Обзор

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.

Вмешательства

  • Другое 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.
  • Другое 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

Первичные конечные точки

  • Comfort [Срок оценки: 2 hours after initiation of NIV]
Вторичные конечные точки (10)
  • Anxiety [Срок оценки: Before and 30 minuts, 2 hours and 24 hours after the implementation of the NIV]
  • First NIV session duration [Срок оценки: At the end of the first NIV session]
  • Comfort [Срок оценки: Before and 30 minuts and 24 hours after the implementation of the NIV]
  • TcpCO2 [Срок оценки: Before and 30 minuts, 2 hours and 24 hours after the implementation of the NIV]
  • NIV duration [Срок оценки: after the first 24 hours of treatment]
  • dyspnea [Срок оценки: 2 hours after the setting up of the NIV]
  • Intubation [Срок оценки: Day 28]
  • Stay duration [Срок оценки: Day 28]
  • anxiolytic treatment prescription [Срок оценки: Day 28]
  • stress [Срок оценки: Before and 30 minuts and 2 hours after the implementation of the NIV]

Критерии участия

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

Критерии включения

  • Glasgow score = 15
  • Need during use of non-invasive ventilation

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

Франция · 1 центр
  • Rennes University Hospital — Rennes

Идентификаторы

NCT: NCT04220463 · 35RC19_9747_HYVIR · 2019-A02238-49 · 19/08/14/42258

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗