NCT00202319

Brief Summary

Sedation is an important treatment when caring for the critically ill patient on a respirator. Adequate sedation has been found to reduce stress, promote relaxation, induce amnesia, improve the tolerance of the respirator, and generally assist nursing care. However all sedation produces side effects for the patients. The aim of this study is to measure the effectiveness of two approaches to sedation management in an Australian Intensive Care unit.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
316

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2001

Shorter than P25 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

November 1, 2001

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2002

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

September 20, 2005

Status Verified

September 1, 2005

First QC Date

September 14, 2005

Last Update Submit

September 14, 2005

Conditions

Respiration Disorders

Keywords

sedationmechanical ventilationsedation protocolscritical careintensive care outcomesstaffing

Outcome Measures

Primary Outcomes (1)

  • Duration of Ventilation

Secondary Outcomes (3)

  • Length of stay

  • Tracheostomy insertion rate

  • Self extubation rate

Interventions

Sedation management protocolPROCEDURE

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • mechanically ventilated

You may not qualify if:

  • cardiac surgery patients
  • those patients readmitted to the ICU who had been on the study during a previous admission were excluded for any subsequent admissions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Melbourne Hospital

Melbourne, Victoria, 3050, Australia

Location

Related Publications (2)

  • Rose RL, Bucknall T. Staff perceptions on the use of a sedation protocol in the intensive care setting. Aust Crit Care. 2004 Nov;17(4):151-9. doi: 10.1016/s1036-7314(04)80020-1.

    PMID: 18038524RESULT

  • Bucknall TK, Manias E, Presneill JJ. A randomized trial of protocol-directed sedation management for mechanical ventilation in an Australian intensive care unit. Crit Care Med. 2008 May;36(5):1444-50. doi: 10.1097/CCM.0b013e318168f82d.

    PMID: 18434914DERIVED

MeSH Terms

Conditions

Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Tracey K Bucknall, RN PhD

    University of Melbourne

    PRINCIPAL INVESTIGATOR

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

September 14, 2005

First Posted

September 20, 2005

Study Start

November 1, 2001

Study Completion

September 1, 2002

Last Updated

September 20, 2005

Record last verified: 2005-09

Locations

AU(1)