Efficacy of Music on Reduction of Sedative Drugs in Mechanically Ventilated Intensive Care Unit Patients

Mechanically Ventilated ICU Patients Clinical Trial

— MUSIC  

Official title:

M.U.S.I.C (MUSicotherapy in the Intensive Care) Interventional, Pilot, Cross-Over, in Mechanically-Ventilated Patients on ICU Ward

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00880035
• Other study ID #: 08-105-R2
• Secondary ID: CRC-PAFI-09
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: April 10, 2009
• Last updated: April 20, 2009
• Start date: December 2008
• Est. completion date: December 2010

Study information

• Verified date: April 2009
• Source: Université de Sherbrooke
• Contact: Olivier Lesur, MD
• Phone: (819)346-1110
• Email: olivier.lesur[@]usherbrooke.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adults older than 18 years old

• expected time of mechanical ventilation of more than 72 hours

• sedation needs for a scale of Sedation-Agitation Scale (SAS) more than 1

Exclusion Criteria:

• hearing impairment

• pregnancy

• needs of vasopressin

• needs of curarisation

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mechanically Ventilated ICU Patients
• Sedative Drug Consumption

Intervention

Device:
• MP3 music program listening
3 days with two 1 hour periods of headset music listening (1 day on, 1 day wash-out, 1 day off)

Locations

Country	Name	City	State
Canada	CHUS	Sherbrooke	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Université de Sherbrooke	Centre de Recherche Clinique CHUS

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sedative drug consumption in mechanically ventilated ICU patients		3 days	Yes
Secondary	stress neuropeptide blood content evolution with MUSIC listening		3 days	No