Respiratory Failure
Conditions
Keywords
Respiratory failure, NIV, Musical intervention
Brief summary
Non-invasive ventilation (NIV) might be associated with anxiety, thus leading to NIV failure, and intubation. Music therapy has been used in various clinical context, including in ICU patients under mechanical ventilation. We aim to evaluate the effect of a musical intervention on respiratory comfort during NIV for acute respiratory failure.
Detailed description
We plan a randomized controlled trial with 3 different arms, in ICU patients requiring NIV for acute respiratory failure : usual care, sensory isolation and sensory isolation and musical intervention.At the onset of respiratory failure, each patient will be randomized in one of the 3 arms. Usual care assigned patients will receive NIV according to each unit protocol; sensory isolation assigned patients will receive NIV associated with a mask obscuring the eyes and a noise-reducing headset.musical intervention patients will receive a 30 minutes musical intervention during each NIV session. Respiratory discomfort will be blindly assessed before, immediately after NIV is correctly set (5 minutes), at 30 minutes, and at hours 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 according to NIV session length, and at the end of NIV session during each NIV session.
Interventions
BEHAVIORALMusical intervention and sensory isolation
30 minutes musical intervention during NIV will be administrated, along with sensory isolation (mask obscuring the eyes)
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* respiratory distress requiring NIV * Glasgow coma score above 12
Exclusion criteria
* NIV contraindication : Hemodynamic failure, neurologic failure, head trauma, vomiting * Severe hypoacusis people without hearing device * Decision to limit active treatment with an estimated life expectancy of less than 48 hours
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Variation of respiratory discomfort during the 30 first minutes of NIV | 30 minutes | Measure of respiratory discomfort at the beginning and the end of the first NIV session, with an analogic visual scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of NIV failure | participants will be followed for the duration of hospital stay or maximum 28 days | NIV failure |
| Quality of life | 3 months | Questionnaire |
| Evolution of respiratory parameters | participants will be followed for the duration of hospital stay or maximum 28 days | Measure of respiratory rate |
| Post traumatic stress disorder | 3 months | questionnaire |
| overall assessment of NIV (in terms of discomfort, satisfaction, and trauma) | 3 months | Questionnaire (scale) |
| Evolution of cardiovascular parameters | participants will be followed for the duration of hospital stay or maximum 28 days | Measure of heart rate |
Countries
France
Outcome results
None listed