Sleep Investigation in Respirator Treated ICU Patients: the Importance of Intensive Environment
NCT ID: NCT01681043
Last Updated: 2015-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
19 participants
INTERVENTIONAL
2012-09-30
2013-12-31
Brief Summary
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Sleep disturbances in the ICU seem to lead to development of delirium, prolonged ICU stay and increased mortality.
The hypothesis of this study is: minimizing of disturbing factors in the ICU, such as noise, light, therapeutic and diagnostic procedures between 10 p.m. and 6 a.m. will improve sleep quality in respirator treated ICU patients.
Methods: randomized interventional study. 48-hour polysomnographic sleep measurement acc. AASM's standard in 46 awake respirator treated patients: 24 hours under ordinary circumstances and 24 hours under the protocol 'Quiet in the room' between 10 p.m. and 6 a.m. after randomization.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
SINGLE
Study Groups
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24 hour PSG under ordinary conditions
24 hour PSG in 46 patients under ordinary (routine) conditions
No interventions assigned to this group
24 hours PSG under protocol 'Quiet in the room'
24 hour PSG in the same 46 patients with protocol 'Quiet in the room' from 10 p.m. til 6 a.m.
protocol 'Quiet in the room'
Protocol 'Quite in the room' between 10 p.m. and 6 a.m.
* nurse nearby
* no visits after 10 p.m.
* decreased alarm sound in ventilator and monitor
* decreased light intensity
* no unnecessary conversations around the patient
* medication should be limited to max 1-2 times in this time period
* no unnecessary therapeutic or diagnostic procedures in this time period
* earplugs and sleep masks
Interventions
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protocol 'Quiet in the room'
Protocol 'Quite in the room' between 10 p.m. and 6 a.m.
* nurse nearby
* no visits after 10 p.m.
* decreased alarm sound in ventilator and monitor
* decreased light intensity
* no unnecessary conversations around the patient
* medication should be limited to max 1-2 times in this time period
* no unnecessary therapeutic or diagnostic procedures in this time period
* earplugs and sleep masks
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* cerebral hemorrhage or infarction during the current hospitalization
* delirium
* inotropes and/or vasopressors
18 Years
ALL
No
Sponsors
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Vejle Hospital
OTHER
Responsible Party
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Yuliya Boyko
MD
Locations
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Department of Anaesthesia and Intensive Care, Vejle Hospital
Vejle, , Denmark
Countries
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Other Identifiers
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S-20120001
Identifier Type: -
Identifier Source: org_study_id
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