Noise in the ICUNCT01826799
Noise in the Intensive Care Unit
An observational study of Noise in the ICU and Sleep Quality in Adult ICU Patients, run by Jeroen Bosch Ziekenhuis at 6 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Noise in the ICU, Sleep Quality in Adult ICU Patients
- How many people
- 75 participants
- Where
- 6 sitesNetherlands
- Study dates
- Apr 2013to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adult ICU patient
- RASS -2 - +1
- 48 hours after admission on ICU
- Expected ICU stay >24 hours
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Netherlands6 sites
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, North Brabant, 5200 ME
Onze Lieve Vrouwe Gasthuis
Amsterdam, North Holland, 1091AC
Gelre Ziekenhuizen
Apeldoorn, Gelderland, 7334 DZ
Radboud Universitair Medisch Centrum
Nijmegen, Gelderland, 6525 GA
Elisabeth Ziekenhuis
Tilburg, North Brabant, 5022 GC
Isala Klinieken
Zwolle, Overijssel, 8011 JW
About this study
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.
Read more
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
- To gather information on how Dutch ICUs perform on sound levels
- Average sound pressure level
- Number of sound peaks
- To question patients about their perception of sleep quality (measured by RCSQ)
- Causes of elevated sound pressure levels
- Identification of the most annoying sounds experienced by the patient
Secondary
- Incidence of delirium measured by CAM-ICU
Read the 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
- Keywords
- sleep, noise, ICU, delirium, RCSQ
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionOct 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Noise in the ICUStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeroen Bosch Ziekenhuis
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Healthcare
- Responsible party
- Principal investigator, K.S. Simons, Jeroen Bosch Ziekenhuis
- Investigators
- Koen Simons, MD, Principal investigator, Jeroen Bosch Ziekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01826799
- Sponsor's protocol ID
- ICUnoise
- Status last verified
- Jan 2016
- First submitted
- 4 Apr 2013
- Last updated
- 15 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 30290829
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noise in the Intensive Care Unit and Its Influence on Sleep Quality: a Nationwide Survey in Dutch Intensive Care Units
- ClinicalTrials.gov ID
- NCT01826799
- Acronym / sponsor ID
- ICUnoise
- Keywords
- sleep, noise, ICU, delirium, RCSQ
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Jeroen Bosch ZiekenhuisUniversity, hospital or other
- Collaborators
- Philips Healthcare
- Study start
- Apr 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 9 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- To gather information on how Dutch ICUs perform on sound levels
- Average sound pressure level
- Number of sound peaks
- To question patients about their perception of sleep quality (measured by RCSQ)
- Causes of elevated sound pressure levels
- Identification of the most annoying sounds experienced by the patient
Secondary
- Incidence of delirium measured by CAM-ICU
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Adult ICU patient
- RASS -2 - +1
- Expected ICU stay >24 hours
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Noise Level
Time frame: 6 months
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
1 secondary outcome
Sleep quality of ICU patients
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2016.
- Derived from this study: PubMed 30290829Simons 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.
Related trials for Noise in the ICU
Not yet recruiting
The Effect of Pink Noise and the Quiet Night Intervention on Sleep Parameters in Intensive Care Unit Patients: A Single-Center Randomized Controlled Trial
Sleep Disturbance, Intensive Care Units
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Koen Simons, MD principal investigator
Jeroen Bosch Ziekenhuis
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Noise in the ICU and Sleep Quality in Adult ICU Patients, run by Jeroen Bosch Ziekenhuis at 6 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Noise Level (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01826799, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2016.