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.
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.
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:
- the differences between patients receiving protocol-directed sedation management compared with non protocol-directed sedation management;
- the differences in patient perceptions of mechanical ventilation during protocol-directed sedation management as compared to non protocol-directed sedation management following extubation, and;
- 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.
- Conditions
- Respiration Disorders
- 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.
Duration of Ventilation
Secondary outcomes (3)
Length of stay
Tracheostomy insertion rate
Self extubation rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startNov 2001
- Study completionSep 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiration DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Melbourne Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of Melbourne, Australian College of Critical Care Nurses, Abbott
- Investigators
- Tracey K Bucknall, RN PhD, Principal investigator, University of Melbourne
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 18038524Bucknall 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00202319
- Acronym / sponsor ID
- 2001.102
- Conditions
- Respiration Disorders
- Keywords
- sedation, mechanical ventilation, sedation protocols, critical care, intensive care outcomes, staffing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 316 participants
- Lead sponsor
- Melbourne HealthUniversity, hospital or other
- Collaborators
- University of Melbourne, Australian College of Critical Care Nurses, Abbott
- Study start
- Nov 2001
- Study completion
- Sep 2002
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- the differences between patients receiving protocol-directed sedation management compared with non protocol-directed sedation management;
- the differences in patient perceptions of mechanical ventilation during protocol-directed sedation management as compared to non protocol-directed sedation management following extubation, and;
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- mechanically ventilated
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sedation management protocol | Procedure or surgery | – |
Primary outcome
Duration of Ventilation
3 secondary outcomes
Length of stay
Tracheostomy insertion rate
Self extubation rate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2005.
- Results publication: PubMed 18038524Rose 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.
- Derived from this study: PubMed 18434914Bucknall 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tracey K Bucknall, RN PhD principal investigator
University of Melbourne
1 site in 1 country: see every site and its status.
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.