Noise in the Intensive Care Unit

Noise in the ICU Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01826799
• Other study ID #: ICUnoise
• Status: Completed
• Phase: N/A
• First received: April 4, 2013
• Last updated: January 13, 2016
• Start date: April 2013
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Jeroen Bosch Ziekenhuis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherands: CCMO
• Study type: Observational

Clinical Trial 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. 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Noise in the ICU
• Sleep Quality in Adult ICU Patients

Locations

Country	Name	City	State
Netherlands	Jeroen Bosch Ziekenhuis	's-Hertogenbosch	Noord Brabant
Netherlands	Onze Lieve Vrouwe Gasthuis	Amsterdam	Noord Holland
Netherlands	Gelre Ziekenhuizen	Apeldoorn	Gelderland
Netherlands	Radboud Universitair Medisch Centrum	Nijmegen	Gelderland
Netherlands	Elisabeth Ziekenhuis	Tilburg	Noord Brabant
Netherlands	Isala Klinieken	Zwolle	Overijssel

Sponsors (2)

Lead Sponsor	Collaborator
Jeroen Bosch Ziekenhuis	Philips Healthcare

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No