Effectiveness of Sedation Management in an Australian Intensive Care Unit

Respiration Disorders Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00202319
• Other study ID #: 2001.102
• Status: Completed
• Phase: N/A
• First received: September 14, 2005
• Last updated: September 14, 2005
• Start date: November 2001
• Est. completion date: September 2002

Study information

• Verified date: September 2005
• Source: Melbourne Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Interventional

Clinical 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. The aim of this study is to measure the effectiveness of two approaches to sedation management in an Australian Intensive Care unit.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 316
• Est. completion date: September 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years and older

Eligibility

Inclusion Criteria:

• mechanically ventilated

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Respiration Disorders

Intervention

Procedure:
• Sedation management protocol

Locations

Country	Name	City	State
Australia	Royal Melbourne Hospital	Melbourne	Victoria

Sponsors (4)

Lead Sponsor	Collaborator
Melbourne Health	Abbott, Australian College of Critical Care Nurses, University of Melbourne

Country where clinical trial is conducted

Australia, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of Ventilation
Secondary	Length of stay
Secondary	Tracheostomy insertion rate
Secondary	Self extubation rate