Back to resultsInterest 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 (HYVIR)
Primary Purpose
Chronic Obstructive Pulmonary Disease (COPD), Obesity With a BMI Greater Than 30, Acute Respiratory Distress in Adult Intensive Care
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Hypnosis + NIV
NIV
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease (COPD)
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 nd/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
Sites / Locations
- Rennes University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Hypnosis group
Control group
Arm Description
For the hypnosis group, hypnotic support is set up by an IDE previously trained and dedicated during the implementation of the NIV. The dedicated 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 IDE.
In the control group, in order to preserve the knowledge of the evaluator, the 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.
Outcomes
Primary Outcome Measures
Comfort
Quantification of comfort by a Digital Verbal Comfort Scale after 2 hours of NIV (from 0 to 10, 0 being the minimum comfort felt and 10 the maximum comfort felt by the patient)
Secondary Outcome Measures
Anxiety
Assessment of anxiety (Numerical Verbal Scale from 0 to 10) 2 hours and 24 hours of the implementation of the NIV
First NIV session duration
Calculation of the number of hours of the first NIV session
Comfort
Comfort assessment 24 hours after the implementation of the NIV (Digital Verbal Scale from 0 to 10)
TcpCO2
Decrease in PaCO2: Installation of a transcutaneous sensor and measurement of TcpCO2 2 hours and 24 hours after the establishment of the NIV
NIV duration
Calculation of the number of hours of NIV in the first 24 hours of treatment
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.
Intubation
Number of intubations: calculation of the number of patients intubated during the ICU stay.
Stay duration
Duration of stay in intensive care
anxiolytic treatment prescription
Record of the number of patients who had to have a prescription for anxiolytics during hospitalization in intensive care.
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).
Full Information
NCT ID
NCT04220463
First Posted
December 20, 2019
Last Updated
November 15, 2022
Sponsor
Rennes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04220463
Brief Title
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
Acronym
HYVIR
Official Title
HYVIR : 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 From Acute Respiratory Distress in Adult Intensive Care
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 20, 2021 (Actual)
Primary Completion Date
November 20, 2023 (Anticipated)
Study Completion Date
November 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD), Obesity With a BMI Greater Than 30, Acute Respiratory Distress in Adult Intensive Care
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective monocentric, controlled, randomized, superiority, open study with a blind assessor, on two parallel groups.
Masking
Outcomes Assessor
Masking Description
Patient randomization will be done online.
SETTING UP AND MAINTAINING THE INSU People having knowledge of the randomization group
Doctor in charge of the patient
IDE dedicated to hypnosis (present throughout the procedure, regardless of the randomization group)
Patient People not having knowledge of the randomization group
assessor = other IDE or doctor not directly taking care of the patient assessor present at 4 times: inclusion, H0, H2 and H24 but absent during the procedure 1 single assessor for the 4 times of the same patient
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hypnosis group
Arm Type
Experimental
Arm Description
For the hypnosis group, hypnotic support is set up by an IDE previously trained and dedicated during the implementation of the NIV. The dedicated 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 IDE.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
In the control group, in order to preserve the knowledge of the evaluator, the 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.
Intervention Type
Other
Intervention Name(s)
Hypnosis + NIV
Intervention Description
For the hypnosis group, hypnotic support is set up by an IDE previously trained and dedicated during the implementation of the NIV. The dedicated 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 IDE.
Intervention Type
Other
Intervention Name(s)
NIV
Intervention Description
In the control group, in order to preserve the knowledge of the evaluator, the 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 Measure Information:
Title
Comfort
Description
Quantification of comfort by a Digital Verbal Comfort Scale after 2 hours of NIV (from 0 to 10, 0 being the minimum comfort felt and 10 the maximum comfort felt by the patient)
Time Frame
after 2 hours of NIV
Secondary Outcome Measure Information:
Title
Anxiety
Description
Assessment of anxiety (Numerical Verbal Scale from 0 to 10) 2 hours and 24 hours of the implementation of the NIV
Time Frame
Before and 30 minuts, 2 hours and 24 hours after the implementation of the NIV
Title
First NIV session duration
Description
Calculation of the number of hours of the first NIV session
Time Frame
At the end of the first NIV session
Title
Comfort
Description
Comfort assessment 24 hours after the implementation of the NIV (Digital Verbal Scale from 0 to 10)
Time Frame
Before and 30 minuts and 24 hours after the implementation of the NIV
Title
TcpCO2
Description
Decrease in PaCO2: Installation of a transcutaneous sensor and measurement of TcpCO2 2 hours and 24 hours after the establishment of the NIV
Time Frame
Before and 30 minuts, 2 hours and 24 hours after the implementation of the NIV
Title
NIV duration
Description
Calculation of the number of hours of NIV in the first 24 hours of treatment
Time Frame
after the first 24 hours of treatment
Title
dyspnea
Description
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.
Time Frame
2 hours after the setting up of the NIV
Title
Intubation
Description
Number of intubations: calculation of the number of patients intubated during the ICU stay.
Time Frame
Day 28
Title
Stay duration
Description
Duration of stay in intensive care
Time Frame
Day 28
Title
anxiolytic treatment prescription
Description
Record of the number of patients who had to have a prescription for anxiolytics during hospitalization in intensive care.
Time Frame
Day 28
Title
stress
Description
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).
Time Frame
Before and 30 minuts and 2 hours after the implementation of the NIV
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 nd/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
Facility Information:
Facility Name
Rennes University Hospital
City
Rennes
State/Province
Bretagne
ZIP/Postal Code
35033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claude Faleur, nurse
Phone
0299284321
Email
claude.faleur@chu-rennes.fr
First Name & Middle Initial & Last Name & Degree
Violaine BENOIT, project leader
Phone
0299289741
Email
violaine.benoit@club-internet.fr
First Name & Middle Initial & Last Name & Degree
Claude Faleur, nurse
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
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