Trial record 4 of 16 for:    Open Studies | "Noise"

Noise in the Intensive Care Unit

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Jeroen Bosch Ziekenhuis
Sponsor:
Collaborator:
Philips Healthcare
Information provided by (Responsible Party):
K.S. Simons, Jeroen Bosch Ziekenhuis
ClinicalTrials.gov Identifier:
NCT01826799
First received: April 4, 2013
Last updated: April 16, 2013
Last verified: April 2013
  Purpose

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


Condition
Noise in the ICU
Sleep Quality in Adult ICU Patients

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Noise in the Intensive Care Unit and Its Influence on Sleep Quality: a Nationwide Survey in Dutch Intensive Care Units

Resource links provided by NLM:


Further study details as provided by Jeroen Bosch Ziekenhuis:

Primary Outcome Measures:
  • Noise Level [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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


Secondary Outcome Measures:
  • Sleep quality of ICU patients [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 90
Study Start Date: April 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01826799

Contacts
Contact: Koen Simons, MD 0031735532447 k.simons@jbz.nl
Contact: Eva Verweij, MD 0031651696678 mail@evaverweij.net

Locations
Netherlands
Gelre Ziekenhuizen Not yet recruiting
Apeldoorn, Gelderland, Netherlands, 7334 DZ
Contact: Peter Spronk, MD PhD       p.spronk@gelre.nl   
Radboud Universitair Medisch Centrum Recruiting
Nijmegen, Gelderland, Netherlands, 6525 GA
Contact: Mark van den Boogaard, RN, PhD         
Jeroen Bosch Ziekenhuis Recruiting
's-Hertogenbosch, Noord Brabant, Netherlands, 5200 ME
Contact: Koen Simons, MD       k.simons@jbz.nl   
Elisabeth Ziekenhuis Recruiting
Tilburg, Noord Brabant, Netherlands, 5022 GC
Contact: Annemarie Oldenbeuving, MD       a.oldenbeuving@elisabeth.nl   
Onze Lieve Vrouwe Gasthuis Not yet recruiting
Amsterdam, Noord Holland, Netherlands, 1091AC
Contact: H Feijen, MD         
Isala Klinieken Not yet recruiting
Zwolle, Overijssel, Netherlands, 8011 JW
Contact: Hans Sonneveld, MD       j.p.c.sonneveld@isala.nl   
Sponsors and Collaborators
Jeroen Bosch Ziekenhuis
Philips Healthcare
Investigators
Principal Investigator: Koen Simons, MD Jeroen Bosch Ziekenhuis
  More Information

No publications provided

Responsible Party: K.S. Simons, MD, Jeroen Bosch Ziekenhuis
ClinicalTrials.gov Identifier: NCT01826799     History of Changes
Other Study ID Numbers: ICUnoise
Study First Received: April 4, 2013
Last Updated: April 16, 2013
Health Authority: Netherlands: Centraal College Mensgebonden Onderzoek

Keywords provided by Jeroen Bosch Ziekenhuis:
sleep
noise
ICU
delirium
RCSQ

ClinicalTrials.gov processed this record on September 16, 2014