Status:

COMPLETED

Noise in the Intensive Care Unit

Lead Sponsor:

Jeroen Bosch Ziekenhuis

Collaborating Sponsors:

Philips Healthcare

Conditions:

Noise in the ICU

Sleep Quality in Adult ICU Patients

Eligibility:

All Genders

18-100 years

Brief Summary

Rationale: Sound levels in the Intensive Care Unit are frequently reported to exceed the recommended levels. It is plausible to assume that this causes sleep disturbance in the patients on the ICU. G...

Detailed Description

An exploratory prospective-observational multi-center study with a total of 6 participating hospitals will be performed. We will include 15 patients per center. Characteristics of the participating IC...

Eligibility Criteria

Inclusion

  • Adult ICU patient
  • RASS -2 - +1
  • 48 hours after admission on ICU
  • Expected ICU stay \>24 hours

Exclusion

  • Unfavourable prognosis (life expectancy \< 48 hours)
  • Inability to understand Dutch, including total deafness
  • Inability to complete visual analog scale due to visual impairment blindness, and/or severe psychomotor retardation
  • Delirium (defined as positive CAM-ICU)
  • Participation of the patient in other studies

Key Trial Info

Start Date :

April 1 2013

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

December 1 2015

Estimated Enrollment :

75 Patients enrolled

Trial Details

Trial ID

NCT01826799

Start Date

April 1 2013

End Date

December 1 2015

Last Update

January 15 2016

Active Locations (6)

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Page 1 of 2 (6 locations)

1

Gelre Ziekenhuizen

Apeldoorn, Gelderland, Netherlands, 7334 DZ

2

Radboud Universitair Medisch Centrum

Nijmegen, Gelderland, Netherlands, 6525 GA

3

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, North Brabant, Netherlands, 5200 ME

4

Elisabeth Ziekenhuis

Tilburg, North Brabant, Netherlands, 5022 GC