NCT00466492

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 27, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

March 19, 2010

Status Verified

June 1, 2009

Enrollment Period

2.1 years

First QC Date

April 26, 2007

Last Update Submit

March 18, 2010

Conditions

Critical IllnessLength of StayRespiration, ArtificialIntensive Care Units

Keywords

Drug Administration ScheduleIntensive Care UnitsLength of StayRespiration, ArtificialStress Disorders, Post-Traumatic/etiology/*psychologyCritical Illness/*psychologyPneumonia/prevention & controlHypnotics and Sedatives/*administration & dosage

Outcome Measures

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

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

Study Arms (1)

No sedatation intervention

OTHER

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

Interventions

Sedation or no sedation during mechanical ventilationPROCEDURE

No sedation to critically ill patients

Also known as: Awake, intensive care, Denmark, Mechanical ventilation
No sedatation intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Raised intracranial pressure
  • Pregnant
  • Treatment with muscle relaxants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anaesthesiologic-intensive Care Department, Odense University Hospital

Odense C, Odense C, 5000, Denmark

Location

Related Publications (6)

  • Kress JP, Pohlman AS, O'Connor MF, Hall JB. Daily interruption of sedative infusions in critically ill patients undergoing mechanical ventilation. N Engl J Med. 2000 May 18;342(20):1471-7. doi: 10.1056/NEJM200005183422002.

    PMID: 10816184RESULT

  • Kress JP, Gehlbach B, Lacy M, Pliskin N, Pohlman AS, Hall JB. The long-term psychological effects of daily sedative interruption on critically ill patients. Am J Respir Crit Care Med. 2003 Dec 15;168(12):1457-61. doi: 10.1164/rccm.200303-455OC. Epub 2003 Oct 2.

    PMID: 14525802RESULT

  • Schweickert WD, Gehlbach BK, Pohlman AS, Hall JB, Kress JP. Daily interruption of sedative infusions and complications of critical illness in mechanically ventilated patients. Crit Care Med. 2004 Jun;32(6):1272-6. doi: 10.1097/01.ccm.0000127263.54807.79.

    PMID: 15187505RESULT

  • Strom T, Stylsvig M, Toft P. Long-term psychological effects of a no-sedation protocol in critically ill patients. Crit Care. 2011;15(6):R293. doi: 10.1186/cc10586. Epub 2011 Dec 13.

    PMID: 22166673DERIVED

  • Strom T, Johansen RR, Prahl JO, Toft P. Sedation and renal impairment in critically ill patients: a post hoc analysis of a randomized trial. Crit Care. 2011;15(3):R119. doi: 10.1186/cc10218. Epub 2011 May 4.

    PMID: 21542927DERIVED

  • Strom T, Martinussen T, Toft P. A protocol of no sedation for critically ill patients receiving mechanical ventilation: a randomised trial. Lancet. 2010 Feb 6;375(9713):475-80. doi: 10.1016/S0140-6736(09)62072-9. Epub 2010 Jan 29.

    PMID: 20116842DERIVED

Related Links

MeSH Terms

Conditions

Critical IllnessRespiratory AspirationStress Disorders, TraumaticPneumonia

Interventions

Wake protein, DrosophilaCritical Carehemoglobin Denmark HillRespiration, Artificial

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract DiseasesTrauma and Stressor Related DisordersMental DisordersRespiratory Tract InfectionsInfectionsLung Diseases

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesAirway ManagementResuscitationEmergency TreatmentRespiratory Therapy

Study Officials

  • Palle Toft, Professor

    Institute of Clinical Research

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 26, 2007

First Posted

April 27, 2007

Study Start

April 1, 2007

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

March 19, 2010

Record last verified: 2009-06

Locations

DK(1)