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Respiration DisordersNCT00202319

Effectiveness of Sedation Management in an Australian Intensive Care Unit

A study testing Sedation management protocol in people with Respiration Disorders, run by Melbourne Health at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 17 years and older
Conditions the study is for
Respiration Disorders
What is being tested?
Sedation management protocol
Type of treatment
Surgery or procedure
How many people
316 participants
Where
1 siteAustralia
Study dates
Nov 2001to Sep 2002
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 17 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • mechanically ventilated

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Australia1 site
  • Royal Melbourne Hospital

    Melbourne, Victoria, 3050

Other trials in Australia

About this study

Official title: Evaluating the Effectiveness of Protocol Directed Sedation Management With Non-Protocol Directed Sedation Management on Mechanically Ventilated Patients in an Australian Intensive Care Unit.

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.

Read the detailed description

Sedation is an integral part of treatment in caring for the critically ill, ventilated patient. Adequate sedation has been found to reduce stress, promote relaxation, induce amnesia, improve the tolerance of ventilatory support, and generally assist nursing care. However, all the sedative agents produce significant side effects such as loss of consciousness, amnesia and haemodynamic instability. In view of the complex characteristics associated with sedative agents, it is important to systematically assess and evaluate their effectiveness in the clinical area. Two issues are important in determining the effective use of these agents. The first issue relates to the use of specific sedation scales to facilitate consistent interpretations among clinicians. The use of such scales is limited in Australia. The second issue relates to the practice of protocol-directed sedation. Despite support for decision-making tools to assist clinicians choice of sedative agents, few studies have evaluated their effectiveness. This research aims to compare the effectiveness of protocol-directed sedation management with traditional non protocol-directed practice in an Australian intensive care unit (ICU). In many Australian ICUs, the bedside nurse titrates the mechanical ventilation and sedation administration in consultation with the medical staff, usually in an unstructured manner.

This project builds upon a significant North American study that found a substantial decrease in the duration of mechanical ventilation, length of stay and rate of tracheostomy insertion following the implementation of a structured sedation protocol by nurses. However an exact replication of the protocol is not possible due to the lack of drug availability in Australia and the preferred drug regimes of RMH intensive care consultants. In addition, there are very few studies that document patients' memories of their experience being ventilated whilst sedated, despite documented discomfort such as anxiety, panic and difficulty synchronizing with the ventilator. There is a similar lack of literature on staff perceptions during the implementation of a multidisciplinary sedation protocol.

The research questions for this study are designed to examine three areas:

  1. the differences between patients receiving protocol-directed sedation management compared with non protocol-directed sedation management;
  2. the differences in patient perceptions of mechanical ventilation during protocol-directed sedation management as compared to non protocol-directed sedation management following extubation, and;
  3. staff perceptions of using a sedation protocol in managing critically ill mechanically ventilated patients.

The design is a prospective, randomised, controlled trial studying 316 patients. There will be 158 patients recruited to the control group and 158 patients in the experimental group. The control group will receive the current management and the experimental group will receive protocol-directed sedation management. To explore patient perceptions of their experience, the patients will be interviewed using a semi-structured questionnaire following extubation and after receiving a rating of 4 on the sedation scale for 24 or more hours. In addition, staff perceptions will be surveyed on their attitudes and perceptions of the protocol.

This study will determine the efficacy and outcomes of protocol-directed sedation management of critically ill mechanically ventilated patients in an Australian context. The study will also improve our understanding of the patients' memories and perceptions during this period, which could lead to improved clinical practices and better patient outcomes. In understanding staff perceptions of the sedation protocol and its implementation, it will assist us to identify changes to improve education for new staff and compliance issues for ongoing implementation. It may be further useful in the future development of decision-making tools and their subsequent implementation and evaluation phases.

Being tested
Sedation management protocol
Keywords
sedation, mechanical ventilation, sedation protocols, critical care, intensive care outcomes, staffing
Medical subject headings
Respiration Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sedation management protocolProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Duration of Ventilation

Secondary outcomes (3)
  1. Length of stay

  2. Tracheostomy insertion rate

  3. Self extubation rate

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2005 (estimated)
  2. Study startNov 2001
  3. Study completionSep 2002

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
316 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00202319
Sponsor's protocol ID
2001.102
Status last verified
Sep 2005
First submitted
14 Sep 2005
Last updated
20 Sep 2005
Results posted
No

Publications

  • 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.

    PubMed 18038524
  • 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.

    PubMed 18434914

Questions about this trial

What is this clinical trial studying?

A study testing Sedation management protocol in people with Respiration Disorders, run by Melbourne Health at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of Ventilation. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00202319, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2005.

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