Intensive Care Unit Delirium
Conditions
Keywords
Intensive Care Unit, Delirium, Aromatherapy
Brief summary
The primary objective of this monocenter randomized controlled trial is to assess the efficacy of aromatherapy to prevent delirium in patients hospitalized in an intensive care unit.
Detailed description
Secondary objectives: 1. To assess the efficacy of aromatherapy on : * the level of consciousness, * pain, * the duration of mechanical ventilation, * the occurence of an accidental extubation, * the length of stay in the intensive care unit, * the cumulative duration of delirium episodes, * the time until first episode of delirium, * the use of neuroleptics. 2. To determine the factors influencing the efficacy of aromatherapy. 3. To assess the safety of aromatherapy. Conduct of research: After inclusion, patients will be randomized between the aromatherapy and control groups. Treatment will be started on the same day as randomization. Aromatherapy treatment will consist of a dermal application on the feet of a mixture of essential oils. Control treatment will consist of a dermal application on the feet of apricot vegetable oil. The mixture of essential oils (aromatherapy group) or vegetable oil (control group) will be applied to the arch of the foot by massage, every eight hours, at a rate of six drops per application (3 drops per foot). Treatment will continue until the patient is discharged from the intensive care unit or no later than 15 days after randomization.
Interventions
OTHERBlending of essential oils
The mixture of essential oils will be applied to the arch of the foot by massage every 8 hours (3 times a day, 6 drops per application with 3 drops per foot).
OTHERApricot vegetable oil
The apricot vegetable oil will be applied to the arch of the foot by massage every 8 hours (3 times a day, 6 drops per application with 3 drops per foot).
Sponsors
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years old * Patient hospitalized in an intensive care unit for an expected duration of at least 24 hours * Patient requiring mechanical ventilation with initial therapeutic sedation adapted secondarily for comfort sedation, defined by a RASS score target between -2 and 0 * Patient affiliated to/beneficiary of a social security scheme
Exclusion criteria
* Allergy to essential and/or vegetable oils * Palliative sedation * Foot skin injury contraindicating the application of an oil * Moribund patient or expected death * History of dementia * Participation to a RIPH-1 study * Pregnant or breastfeeding woman * Patient under legal protection * Patient deprived of liberty by judicial or administrative decision
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of delirium | Up to 15 days after randomization | The occurrence of delirium will be defined by the presence of at least one episode during the patient's stay in the intensive care unit, diagnosed using the CAM-ICU scale. |
Secondary
| Measure | Time frame |
|---|---|
| Score on the Richmond Agitation-Sedation Scale | Up to 15 days after randomization |
| Duration of mechanical ventilation between admission and first extubation | Up to 15 days after randomization |
| Occurrence of at least one accidental extubation during the stay | Up to 15 days after randomization |
| Length of stay in intensive care unit | Up to 15 days after randomization |
| Score on the Behavior-Pain Scale | Up to 15 days after randomization |
| Time until first episode of delirium | Up to 15 days after randomization |
| Duration of neuroleptic treatment | Up to 15 days after randomization |
| Occurrence of a local allergic reaction | Up to 15 days after randomization |
| Cumulative duration of delirium episodes | Up to 15 days after randomization |
Countries
France
Outcome results
None listed