Skip to content

Advantages and Disadvantages of Long Term Sedation in Intensive Care Unit Patients

Advantages and Disadvantages of Long Term Sedation in ICU Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00466492
Enrollment
140
Registered
2007-04-27
Start date
2007-04-30
Completion date
2009-05-31
Last updated
2010-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Intensive Care Units, Length of Stay, Respiration, Artificial

Keywords

Drug Administration Schedule, Intensive Care Units, Length of Stay, Respiration, Artificial, Stress Disorders, Post-Traumatic/etiology/*psychology, Critical Illness/*psychology, Pneumonia/prevention & control, Hypnotics and Sedatives/*administration & dosage

Brief summary

The purpose of the study is to determine whether sedation of the critical ill patient prolongs the time receiving mechanical ventilation.

Detailed description

The golden standard is to sedate critical ill patients receiving mechanical ventilation with daily wake up trials. This is shown to reduce the time receiving mechanical ventilation compared to no wake up trials. We would like to study whether no sedation but only analgesics administered as bolus doses, reduce the time receiving mechanical ventilation. The study is planned as a randomised prospective study, not blinded. The control group is patients receiving sedation with daily wake up trials. The intervention group is not sedated, but receives bolus doses of analgesics (morphine). The endpoint is the time spend receiving mechanical ventilation, lengths of stay on the intensive care unit, and total lengths of stay on the hospital. We also examine the frequency of ventilator associated pneumonia and CT scans of cerebrum. Also we would like to examine the long term psychological effects of sedation, we plan to send some of the patients to a post traumatic stress screening. The effect on the next of kin we plan to study with a questionnaire. As a last thing we would like to study the workload on the nurses.

Interventions

PROCEDURESedation or no sedation during mechanical ventilation

No sedation to critically ill patients

Sponsors

Odense University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Intubated receiving mechanical ventilation * Expected to remain intubated more than 24 hours * Over 18 years

Exclusion criteria

* Raised intracranial pressure * Pregnant * Treatment with muscle relaxants

Design outcomes

Primary

MeasureTime frame
Time receiving mechanical ventilation, total intensive care and hospital length of stay.

Secondary

MeasureTime frame
The frequency of VAP, CTC. The amount of Post Traumatic Stress after 6 month. The patients families experience. The workload on the nursesVAP and CTC during hospital stay. PTSD 1-2 years after the primary stay

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026