NCT01826799

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. Goals/endpoints: to assess sound pressure levels in 6 different Dutch ICU´s and evaluate the effect of higher levels on sleep as perceived by the patient. Study design: observational multicenter study Study population: adult ICU patients \> 18 years old with an expected duration of stay of more than 24 hours Study parameters/endpoints: Primary

  1. 1.To gather information on how Dutch ICUs perform on sound levels
  2. 2.Average sound pressure level
  3. 3.Number of sound peaks
  4. 4.To question patients about their perception of sleep quality (measured by RCSQ)
  5. 5.Causes of elevated sound pressure levels
  6. 6.Identification of the most annoying sounds experienced by the patient

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2013

Typical duration for all trials

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 9, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 15, 2016

Status Verified

January 1, 2016

Enrollment Period

2.5 years

First QC Date

April 4, 2013

Last Update Submit

January 13, 2016

Conditions

Noise in the ICUSleep Quality in Adult ICU Patients

Keywords

sleepnoiseICUdeliriumRCSQ

Outcome Measures

Primary Outcomes (1)

  • Noise Level

    To gather information on how Dutch ICUs perform on sound levels 1. Average sound pressure level (e.g. per shift, over day/night) 2. Number of sound peaks 3. Peak-to-baseline level 4. Etiology of noise - classification of dominant sources

    6 months

Secondary Outcomes (1)

  • Sleep quality of ICU patients

    6 months

Study Arms (1)

adult ICU patients

All adult patients without hearing disabilities and admitted to the ICU more than 48 hours ago, with a Richmond Agitation-Sedation Scale (RASS) of -2 or higher and the capability to understand Dutch are eligible.

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adult patients without hearing disabilities and admitted to the ICU more than 48 hours ago, with a Richmond Agitation-Sedation Scale (RASS) of -2 or higher and the capability to understand Dutch are eligible.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Gelre Ziekenhuizen

Apeldoorn, Gelderland, 7334 DZ, Netherlands

Location

Radboud Universitair Medisch Centrum

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

Jeroen Bosch Ziekenhuis

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

Location

Elisabeth Ziekenhuis

Tilburg, North Brabant, 5022 GC, Netherlands

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, North Holland, 1091AC, Netherlands

Location

Isala Klinieken

Zwolle, Overijssel, 8011 JW, Netherlands

Location

Related Publications (1)

  • Simons KS, Verweij E, Lemmens PMC, Jelfs S, Park M, Spronk PE, Sonneveld JPC, Feijen HM, van der Steen MS, Kohlrausch AG, van den Boogaard M, de Jager CPC. Noise in the intensive care unit and its influence on sleep quality: a multicenter observational study in Dutch intensive care units. Crit Care. 2018 Oct 5;22(1):250. doi: 10.1186/s13054-018-2182-y.

    PMID: 30290829DERIVED

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Koen Simons, MD

    Jeroen Bosch Ziekenhuis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 4, 2013

First Posted

April 9, 2013

Study Start

April 1, 2013

Primary Completion

October 1, 2015

Study Completion

December 1, 2015

Last Updated

January 15, 2016

Record last verified: 2016-01

Locations

NL(6)