Mechanically Ventilated ICU Patients Clinical Trial
Official title:
M.U.S.I.C (MUSicotherapy in the Intensive Care) Interventional, Pilot, Cross-Over, in Mechanically-Ventilated Patients on ICU Ward
Major objective: a three-days interventional cross-over trial [one day music on, one day
wash-out, one day music off][two periods of listening/day], to evaluate:
1. Impact on sedative drug consumption.
2. Alteration of stress neuropeptide blood concentrations.
Population: mechanically-ventilated ICU patients
The investigators hypothesize the music will decrease the need of sedative drugs and reduce
the concentration of neuropeptides in circulation.
The study will imply patients mechanically ventilated for more than 3 days, that require
sedation with benzodiazepine and narcotics.
There will be two groups both of exposed to music and placebo (headphones without music).
The study will be simple blind.
Sedation scale will be followed regularly. Vitals signs and adjustment of sedation will be
recorded by the nurse on the ward. Blood test will be taken before and after placement of
headphones in the morning. We will measure IL-6, cortisol, copeptin, prolactin, CRP.
We will analyse the total reduction dose of sedation and analgesia on a daily basis. We will
consider a fall of 20% of medication to be significative.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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