Noise in the Intensive Care Unit

Noise in the Intensive Care Unit and Its Influence on Sleep Quality: a Nationwide Survey in Dutch Intensive Care Units

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. To gather information on how Dutch ICUs perform on sound levels

   1. Average sound pressure level
   2. Number of sound peaks
2. To question patients about their perception of sleep quality (measured by RCSQ)
3. Causes of elevated sound pressure levels
4. Identification of the most annoying sounds experienced by the patient

Secondary

1) Incidence of delirium measured by CAM-ICU

Study Overview

• Status: Completed
• Conditions: Noise in the ICU; Sleep Quality in Adult ICU Patients

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 ICUs will be collected.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.Sound measurement equipment will be installed in two patient rooms in each ICU and will perform a continuous recording. Sound parameters that will be measured include average sound levels, number and height of peaks and peak-to-baseline level.

Level of sedation is monitored as part of daily care by nurses in all patients every two hours using the RASS.In addition, screening on the presence of delirium is done using the Confusion Assessment Method-ICU (CAM-ICU) every shift.Patients' perception of sleep will be scored (both by the patient and the attending nurse) using the Richards-Campbell Sleep Questionnaire (RCSQ),after the 24 hour recording period from the start of the inclusion and from there on every 24 hours until discharge with a maximum of five days at 07.00 am by the attending nurse.

Data, consisting of patient information and results of measurements and laboratory investigations will be filled in on an electronic Case Record Form (e-CRF).

For the descriptive statistics, values will be given as mean ± SD or median and interquartile ranges, depending on their distribution. Summary tables will be provided for all baseline and follow-up variables. Data will be summarised by producing frequently tabulations for categorical variables and summary statistics for continuously distributed variables with confidence intervals.

All statistical tests are two-sided and statistical significance is defined as a P-value <0.05. All data are analyzed using SPSS version 18.0 (SPSS, Chicago, IL).

Association between noise and delirium will be evaluated using a logistic multivariate regression analysis, correcting for age, severity of disease, infection and sedative use

• Study Type: Observational
• Enrollment (Actual): 75

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Apeldoorn, Gelderland, Netherlands, 7334 DZ
      • Gelre Ziekenhuizen
    • Nijmegen, Gelderland, Netherlands, 6525 GA
      • Radboud Universitair Medisch Centrum
  • Noord Brabant
    • 's-Hertogenbosch, Noord Brabant, Netherlands, 5200 ME
      • Jeroen Bosch Ziekenhuis
    • Tilburg, Noord Brabant, Netherlands, 5022 GC
      • Elisabeth Ziekenhuis
  • Noord Holland
    • Amsterdam, Noord Holland, Netherlands, 1091AC
      • Onze Lieve Vrouwe Gasthuis
  • Overijssel
    • Zwolle, Overijssel, Netherlands, 8011 JW
      • Isala Klinieken

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-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.

Description

Inclusion Criteria:

• Adult ICU patient

• RASS -2 - +1

  • 48 hours after admission on ICU
• Expected ICU stay >24 hours

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Noise Level	To gather information on how Dutch ICUs perform on sound levels; Average sound pressure level (e.g. per shift, over day/night); Number of sound peaks; Peak-to-baseline level; Etiology of noise - classification of dominant sources	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep quality of ICU patients	Patients' perception of sleep will be scored (both by the patient and the attending nurse) using the Richards-Campbell Sleep Questionnaire (RCSQ, see appendix). This will take place after the 24 hour recording period from the start of the inclusion and from there on every 24 hours until discharge with a maximum of five days at 07.00 am by the attending nurse. An additional question will be added to the RCSQ, namely which sound the patient has experienced to be the most annoying/disturbing during his/her stay in the ICU.	6 months

Collaborators and Investigators

• Sponsor: Jeroen Bosch Ziekenhuis
• Collaborators: Philips Healthcare
• Investigators: Principal Investigator: Koen Simons, MD, Jeroen Bosch Ziekenhuis

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: April 4, 2013
• First Submitted That Met QC Criteria: April 4, 2013
• First Posted (Estimate): April 9, 2013

Study Record Updates

• Last Update Posted (Estimate): January 15, 2016
• Last Update Submitted That Met QC Criteria: January 13, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: delirium; sleep; ICU; noise; RCSQ
• Other Study ID Numbers: ICUnoise