OBJECTIVE: To compare protocol-directed sedation management with traditional non-protocol-directed practice in mechanically ventilated patients. DESIGN: Randomized, controlled trial. SETTING:General intensive care unit (24 beds) in an Australian metropolitan teaching hospital. PATIENTS: Adult, mechanically ventilated patients (n = 312). INTERVENTIONS: Patients were randomly assigned to receive sedation directed by formal guidelines (protocol group, n = 153) or usual local clinical practice (control, n = 159). MEASUREMENTS AND MAIN RESULTS: The median (95% confidence interval) duration of ventilation was 79 hrs (56-93 hrs) for patients in the protocol group compared with 58 hrs (44-78 hrs) for patients who received control care (p = .20). Lengths of stay (median [range]) in the intensive care unit (94 [2-1106] hrs vs. 88 (14-962) hrs, p = .58) and hospital (13 [1-113] days vs. 13 (1-365) days, p = .97) were similar, as were the proportions of subjects receiving a tracheostomy (17% vs. 15%, p = .64) or undergoing unplanned self-extubation (1.3% vs. 0.6%, p = .61). Death in the intensive care unit occurred in 32 (21%) patients in the protocol group and 32 (20%) control subjects (p = .89), with a similar overall proportion of deaths in hospital (25% vs. 22%, p = .51). A Cox proportional hazards model, after adjustment for age, gender, Acute Physiology and Chronic Health Evaluation II score, diagnostic category, and doses of commonly used drugs, estimated that protocol sedation management was associated with a 22% decrease (95% confidence interval 40% decrease to 2% increase, p = .07) in the occurrence of successful weaning from mechanical ventilation. CONCLUSIONS: This randomized trial provided no evidence of a substantial reduction in the duration of mechanical ventilation or length of stay, in either the intensive care unit or the hospital, with the use of protocol-directed sedation compared with usual local management. Qualified high-intensity nurse staffing and routine Australian intensive care unit nursing responsibility for many aspects of ventilatory practice may explain the contrast between these findings and some recent North American studies.
RCT Entities:
OBJECTIVE: To compare protocol-directed sedation management with traditional non-protocol-directed practice in mechanically ventilated patients. DESIGN: Randomized, controlled trial. SETTING: General intensive care unit (24 beds) in an Australian metropolitan teaching hospital. PATIENTS: Adult, mechanically ventilated patients (n = 312). INTERVENTIONS:Patients were randomly assigned to receive sedation directed by formal guidelines (protocol group, n = 153) or usual local clinical practice (control, n = 159). MEASUREMENTS AND MAIN RESULTS: The median (95% confidence interval) duration of ventilation was 79 hrs (56-93 hrs) for patients in the protocol group compared with 58 hrs (44-78 hrs) for patients who received control care (p = .20). Lengths of stay (median [range]) in the intensive care unit (94 [2-1106] hrs vs. 88 (14-962) hrs, p = .58) and hospital (13 [1-113] days vs. 13 (1-365) days, p = .97) were similar, as were the proportions of subjects receiving a tracheostomy (17% vs. 15%, p = .64) or undergoing unplanned self-extubation (1.3% vs. 0.6%, p = .61). Death in the intensive care unit occurred in 32 (21%) patients in the protocol group and 32 (20%) control subjects (p = .89), with a similar overall proportion of deaths in hospital (25% vs. 22%, p = .51). A Cox proportional hazards model, after adjustment for age, gender, Acute Physiology and Chronic Health Evaluation II score, diagnostic category, and doses of commonly used drugs, estimated that protocol sedation management was associated with a 22% decrease (95% confidence interval 40% decrease to 2% increase, p = .07) in the occurrence of successful weaning from mechanical ventilation. CONCLUSIONS: This randomized trial provided no evidence of a substantial reduction in the duration of mechanical ventilation or length of stay, in either the intensive care unit or the hospital, with the use of protocol-directed sedation compared with usual local management. Qualified high-intensity nurse staffing and routine Australian intensive care unit nursing responsibility for many aspects of ventilatory practice may explain the contrast between these findings and some recent North American studies.
Authors: Jörg Martin; Anja Heymann; Katrin Bäsell; Ralf Baron; Rolf Biniek; Hartmut Bürkle; Peter Dall; Christine Dictus; Verena Eggers; Ingolf Eichler; Lothar Engelmann; Lars Garten; Wolfgang Hartl; Ulrike Haase; Ralf Huth; Paul Kessler; Stefan Kleinschmidt; Wolfgang Koppert; Franz-Josef Kretz; Heinz Laubenthal; Guenter Marggraf; Andreas Meiser; Edmund Neugebauer; Ulrike Neuhaus; Christian Putensen; Michael Quintel; Alexander Reske; Bernard Roth; Jens Scholz; Stefan Schröder; Dierk Schreiter; Jürgen Schüttler; Gerhard Schwarzmann; Robert Stingele; Peter Tonner; Philip Tränkle; Rolf Detlef Treede; Tomislav Trupkovic; Michael Tryba; Frank Wappler; Christian Waydhas; Claudia Spies Journal: Ger Med Sci Date: 2010-02-02