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Completed

NCT Number: NCT00466492

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

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

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Key information

Conditions

Critical Illness Disease Attributes Infections Intensive Care Units Length of Stay Lung Diseases Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Respiration Disorders Respiration, Artificial Respiratory Aspiration Respiratory Tract Diseases Respiratory Tract Infections Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anaesthesiologic-intensive Care Department, Odense University Hospital

Odense C, 5000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sedation or no sedation during mechanical ventilation

Procedure

No sedation to critically ill patients

Other names: Awake, intensive care, Denmark, Mechanical ventilation

Primary outcomes

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

Secondary outcomes

  1. The frequency of VAP, CTC. The amount of Post Traumatic Stress after 6 month. The patients families experience. The workload on the nurses

    Time frame: VAP and CTC during hospital stay. PTSD 1-2 years after the primary stay

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Official study title

Advantages and Disadvantages of Long Term Sedation in ICU Patients

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Apr 27, 2007
Registry last updated
Mar 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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