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Sleep Investigation in Respirator Treated ICU Patients: the Importance of Intensive Environment

V

Vejle Hospital

Status

Completed

Conditions

Sleep

Treatments

Behavioral: protocol 'Quiet in the room'

Study type

Interventional

Funder types

Other

Identifiers

NCT01681043
S-20120001

Details and patient eligibility

About

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.

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • awake and relevant respirator treated patients with expected 2 or more respirator dags

Exclusion criteria

  • GCS < 11
  • cerebral hemorrhage or infarction during the current hospitalization
  • delirium
  • inotropes and/or vasopressors

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

19 participants in 2 patient groups

24 hour PSG under ordinary conditions
No Intervention group
Description:
24 hour PSG in 46 patients under ordinary (routine) conditions
24 hours PSG under protocol 'Quiet in the room'
Active Comparator group
Description:
24 hour PSG in the same 46 patients with protocol 'Quiet in the room' from 10 p.m. til 6 a.m.
Treatment:
Behavioral: protocol 'Quiet in the room'

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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