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
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
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
;
Observational Model: Cohort, Time Perspective: Prospective