Sleep Investigation in Respirator Treated ICU Patients: the Importance of Intensive Environment
1 other identifier
interventional
19
1 country
1
Brief Summary
Sleep investigation in respirator treated ICU patients: the importance of intensive environment. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedFirst Posted
Study publicly available on registry
September 7, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedMarch 25, 2015
March 1, 2015
1.2 years
August 23, 2012
March 24, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the number of arousals
arousals will be scored during the sleep periods and the index - arousals per hour of sleep - will be counted
per hour of sleep
Secondary Outcomes (5)
total sleep time
24 hours
N1 sleep
24 hours
N2 sleep
24 hours
N3 sleep
24 hours
REM sleep
24 hours
Study Arms (2)
24 hour PSG under ordinary conditions
NO INTERVENTION24 hour PSG in 46 patients under ordinary (routine) conditions
24 hours PSG under protocol 'Quiet in the room'
ACTIVE COMPARATOR24 hour PSG in the same 46 patients with protocol 'Quiet in the room' from 10 p.m. til 6 a.m.
Interventions
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
You may qualify if:
- awake and relevant respirator treated patients with expected 2 or more respirator dags
You may not qualify if:
- GCS \< 11
- cerebral hemorrhage or infarction during the current hospitalization
- delirium
- inotropes and/or vasopressors
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vejle Hospitallead
Study Sites (1)
Department of Anaesthesia and Intensive Care, Vejle Hospital
Vejle, 7100, Denmark
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
August 23, 2012
First Posted
September 7, 2012
Study Start
September 1, 2012
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
March 25, 2015
Record last verified: 2015-03