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

Not Applicable

Recruiting

• Conditions: Acute Respiratory Distress in Adult Intensive Care; Chronic Obstructive Pulmonary Disease (COPD); Obesity With a BMI Greater Than 30
• Interventions: Other: Hypnosis + NIV; Other: NIV

• Registration Number: NCT04220463
• Lead Sponsor: Rennes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-20
• Study First Submitted QC: 2020-01-06
• Study First Posted: 2020-01-07
• Study Start: 2021-11-20
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-22
• Primary Completion: 2025-11-20
• Study Completion: 2025-11-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypnosis group	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.
Control group	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.

Primary Outcome Measures

Name	Time	Method
Comfort	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 Outcome Measures

Name	Time	Method
Comfort	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)
TcpCO2	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
NIV duration	after the first 24 hours of treatment	Calculation of the number of hours of NIV in the first 24 hours of treatment
First NIV session duration	At the end of the first NIV session	Calculation of the number of hours of the first NIV session
Intubation	Day 28	Number of intubations: calculation of the number of patients intubated during the ICU stay.
anxiolytic treatment prescription	Day 28	Record of the number of patients who had to have a prescription for anxiolytics during hospitalization in intensive care.
Anxiety	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
dyspnea	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.
stress	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
Stay duration	Day 28	Duration of stay in intensive care

Trial Locations

Locations (1)

Rennes University Hospital; 🇫🇷 Rennes, Bretagne, France