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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— HYVIR  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04220463
• Other study ID #: 35RC19_9747_HYVIR
• Secondary ID: 2019-A02238-4919
• Status: Recruiting
• Phase: N/A
• Start date: November 20, 2021
• Est. completion date: November 20, 2025

Study information

• Verified date: November 2023
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 20, 2025
• Est. primary completion date: November 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases, Obstructive
• Obesity
• Pulmonary Disease, Chronic Obstructive

Intervention

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.
• 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 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.

Locations

Country	Name	City	State
France	Rennes University Hospital	Rennes	Bretagne

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comfort	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)	2 hours after initiation of NIV
Secondary	Anxiety	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	Before and 30 minuts, 2 hours and 24 hours after the implementation of the NIV
Secondary	First NIV session duration	Calculation of the number of hours of the first NIV session	At the end of the first NIV session
Secondary	Comfort	Comfort assessment at inclusion, 30 minutes and 24 hours after the implementation of the NIV (Digital Verbal Scale from 0 to 10)	Before and 30 minuts and 24 hours after the implementation of the NIV
Secondary	TcpCO2	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	Before and 30 minuts, 2 hours and 24 hours after the implementation of the NIV
Secondary	NIV duration	Calculation of the number of hours of NIV in the first 24 hours of treatment	after the first 24 hours of treatment
Secondary	dyspnea	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.	2 hours after the setting up of the NIV
Secondary	Intubation	Number of intubations: calculation of the number of patients intubated during the ICU stay.	Day 28
Secondary	Stay duration	Duration of stay in intensive care	Day 28
Secondary	anxiolytic treatment prescription	Record of the number of patients who had to have a prescription for anxiolytics during hospitalization in intensive care.	Day 28
Secondary	stress	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	Before and 30 minuts and 2 hours after the implementation of the NIV