Completed

NCT Number: NCT01826799

Noise in the Intensive Care Unit

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

Completed

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Key information

Conditions

Noise in the ICU Confusion Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Quality in Adult ICU Patients

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gelre Ziekenhuizen, Apeldoorn, Gelderland, Netherlands

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Noise Level

Time frame: 6 months
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

Secondary outcomes

Sleep quality of ICU patients

Time frame: 6 months

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.

Sponsors and collaborators

Lead sponsor

Jeroen Bosch Ziekenhuis

Other

Collaborators

Philips Healthcare

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Apr 9, 2013
Registry last updated: Jan 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed