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NCT Number: 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

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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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Acute Respiratory Distress in Adult Intensive Care Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Obesity With a BMI Greater Than 30 Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rennes University Hospital

Rennes, Brittany Region, 35033, France

Location status: Recruiting

Location contact

Claude Faleur, nurse

CONTACT

[email protected]

0299284321

Claude Faleur, nurse

PRINCIPAL_INVESTIGATOR

Violaine BENOIT, project leader

CONTACT

[email protected]

0299289741

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypnosis + NIV

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.

NIV

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.

Primary outcomes

  1. Comfort

    Time frame: 2 hours after initiation of NIV

    Quantification of comfort by a Digital Verbal Comfort Scale 2 hours after initiation of NIV (from 0 to 10, 0 being the minimum comfort felt and 10 the maximum comfort felt by the patient)

Secondary outcomes

  1. Anxiety

    Time frame: Before and 30 minuts, 2 hours and 24 hours after the implementation of the NIV

    Assessment of anxiety (Numerical Verbal Scale from 0 to 10) at inclusion, 30 minutes, 2 hours and 24 hours after the implementation of the NIV

  2. First NIV session duration

    Time frame: At the end of the first NIV session

    Calculation of the number of hours of the first NIV session

  3. Comfort

    Time frame: Before and 30 minuts and 24 hours after the implementation of the NIV

    Comfort assessment at inclusion, 30 minutes and 24 hours after the implementation of the NIV (Digital Verbal Scale from 0 to 10)

  4. TcpCO2

    Time frame: Before and 30 minuts, 2 hours and 24 hours after the implementation of the NIV

    Decrease in PaCO2: Installation of a transcutaneous sensor and measurement of TcpCO2 at inclusion, 30 minutes, 2 hours and 24 hours after the establishment of the NIV

  5. NIV duration

    Time frame: after the first 24 hours of treatment

    Calculation of the number of hours of NIV in the first 24 hours of treatment

  6. dyspnea

    Time frame: 2 hours after the setting up of the NIV

    Assessment of the dyspnea felt by the patient 2 hours after the setting up of the NIV: +2: significant improvement; +1 slight improvement; 0 No change; -1 slight deterioration; -2 significant deterioration.

  7. Intubation

    Time frame: Day 28

    Number of intubations: calculation of the number of patients intubated during the ICU stay.

  8. Stay duration

    Time frame: Day 28

    Duration of stay in intensive care

  9. anxiolytic treatment prescription

    Time frame: Day 28

    Record of the number of patients who had to have a prescription for anxiolytics during hospitalization in intensive care.

  10. stress

    Time frame: Before and 30 minuts and 2 hours after the implementation of the NIV

    Evaluation of the stress of the healthcare team by a numerical verbal scale from 0 to 10 (0 being no stress and 10 the greatest possible stress felt) at inclusion, 30 minutes and 2 hours after NIV initiation

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study 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

Acronym: HYVIR

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jan 7, 2020
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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