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

Sponsor

Odense University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00466492

Collaborator

(none)

140

Enrollment

Location

Arm

Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Critical Illness Length of Stay Respiration, Artificial Intensive Care Units	Procedure: Sedation or no sedation during mechanical ventilation	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Advantages and Disadvantages of Long Term Sedation in ICU Patients

Study Start Date :

Apr 1, 2007

Actual Primary Completion Date :

May 1, 2009

Actual Study Completion Date :

May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Other: No sedatation intervention The intervention group is the normal care in our institution, the control group is the golden standard	Procedure: Sedation or no sedation during mechanical ventilation No sedation to critically ill patients Other Names: Awake intensive care Denmark Mechanical ventilation

Arm

Intervention/Treatment

Other: No sedatation intervention

The intervention group is the normal care in our institution, the control group is the golden standard

Procedure: Sedation or no sedation during mechanical ventilation

No sedation to critically ill patients

Other Names:

Awake

intensive care

Denmark

Mechanical ventilation

Outcome Measures

Primary Outcome Measures

Time receiving mechanical ventilation, total intensive care and hospital length of stay. []

Secondary Outcome Measures

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