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

Odense University Hospital

Status: Completed

Conditions: Length of Stay; Intensive Care Units; Respiration, Artificial; Critical Illness

Treatments: Procedure: Sedation or no sedation during mechanical ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT00466492

22-6-06

Details and patient eligibility

About

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

Full 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.

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

140 participants in 1 patient group

No sedatation intervention

Other group

Description:

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

Treatment:

Procedure: Sedation or no sedation during mechanical ventilation