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 (HYVIR)

June 20, 2025 updated by: Rennes University Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Bretagne
      • Rennes, Bretagne, France, 35033

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Hypnosis group
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.
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.
Placebo Comparator: Control group
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
2 hours after initiation of NIV

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
At the end of the first NIV session
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
after the first 24 hours of treatment
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.
2 hours after the setting up of the NIV
Intubation
Time Frame: Day 28
Number of intubations: calculation of the number of patients intubated during the ICU stay.
Day 28
Stay duration
Time Frame: Day 28
Duration of stay in intensive care
Day 28
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.
Day 28
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
Before and 30 minuts, 2 hours and 24 hours after the implementation of the NIV
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)
Before and 30 minuts and 24 hours after the implementation of the NIV
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
Before and 30 minuts, 2 hours and 24 hours after the implementation of the NIV
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
Before and 30 minuts and 2 hours after the implementation of the NIV

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rennes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 20, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 20, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 20, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 20, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 7, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 35RC19_9747_HYVIR
  • 2019-A02238-49 (Other Identifier: ID RCB)
  • 19/08/14/42258 (Other Identifier: CNRIPH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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