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