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[('', '', '', ''), ('rowRequestNumber', 'Request Number:', '000002', ''), ('rowACTRNumber', 'ACTR Number:', 'ACTRN12605000006640', ''), ('rowStatus', 'Trial Status:', 'Registered', ''), ('rowSubmittedDate', 'Date Submitted:', '7/07/2005', ''), ('rowRegisterdDate', 'Date Registered:', '13/07/2005', ''), ('Trial_Details_Control_rowDateUpdated', 'Date Last Updated:', 'Trial not updated since registration', ''), ('Trial_Details_Control_rowTrialType', 'Registration Type:', 'Prospective', ''), ('', 'Public title:', 'Pathways Home: Chronic Disease Management Partnerships', ''), ('Trial_Details_Control_Update_Value_Step1_1', 'Update:', u'', 'hidden'), ('Trial_Details_Control_Update_Reason_Step1_1', 'Reason:', '', 'hidden'), ('', 'ANZCTR registration title:', 'The effect of a self-management programme supported by computerised symptom feedback on quality of life in community dwelling people with Chronic Obstructive Pulmonary Disease', ''), ('Trial_Details_Control_Update_Value_Step1_2', 'Update:', u'', 'hidden'), ('Trial_Details_Control_Update_Reason_Step1_2', 'Reason:', '', 'hidden'), ('', 'Secondary ID:', u'', ''), ('', 'UTN:', '', ''), ('Trial_Details_Control_Update_Value_Step1_15', 'Update:', u'', 'hidden'), ('Trial_Details_Control_Update_Reason_Step1_15', 'Reason:', '', 'hidden'), ('', 'Trial acronym:', '', ''), ('Trial_Details_Control_Update_Value_Step1_3', 'Update:', u'', 'hidden'), ('tabgreen', 'Condition category:', 'Condition code:', ''), ('', u'Respiratory', u'Chronic obstructive pulmonary disease', ''), ('', 'Description of intervention(s) / exposure:', 'Patients will be recruited at the Royal Hobart Hospital with an acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD). Following discharge, active participants will be provided with a Community Health Nurse mentor who will act to facilitate their self-efficacy over the 1-year duration of the study. 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2
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4
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[]
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5
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6
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Patients randomised to the intervention group will receive a replacement infusion of normal saline and thus have their continuous sedative infusions interrupted each day. The duration of replacement infusion for both groups will be dependant on patient response during the replacement infusion which is to run for a maximum of 6 hours. 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These infusions are occasionally stopped to allow patients to return to consciousness to enable assessment of their neurological function and sedation requirements. A routine daily interruption to sedation has been recommended as a standard of care in ICU patients (Dellinger, Crit Care Med, 2004). This recommendation is based on the work of Kress (NEJM, 2000) who enrolled 180 patients in a medical ICU in Chicago. Several aspects of this work significantly reduce the appropriateness of generalising these results to Australian ICU practice. Fully exploring the impact of a daily interruption to sedation is warranted in the context of Australian ICU practice prior to its adoption as a standard of care.\tIn this pilot study, the standard practice of interruption to sedation on an ad-hoc basis will be compared to a routine interruption to sedation for a defined period each day in Australian ICUs. These comparisons will be based on the length of time that mechanical ventilation, ICU and hospital treatment is required and psychological well being 6 months after discharge from ICU. All patients enrolled in the study will be given an infusion replacing their prescribed sedation for a defined period each day. The replacement infusions will be either normal saline or identical to the patients prescribed sedation. This pilot study will test the proposed blinding procedures and facilitate an appropriate power calculation.', ''), ('Trial_Details_Control_Update_Value_Step3_10', 'Update:', u'', 'hidden'), ('Trial_Details_Control_Update_Reason_Step3_10', 'Reason:', '', 'hidden'), ('', 'Trial website:', '', ''), ('Trial_Details_Control_Update_Value_Step3_11', 'Update:', u'', 'hidden'), ('', 'Presentations / publication list:', '', ''), ('Trial_Details_Control_Update_Value_Step3_12', 'Update:', u'', 'hidden'), ('', 'Name:', 'Professor Sharon McKinley', ''), ('Trial_Details_Control_Update_Value_Step3_13', 'Update:', u'', 'hidden'), ('Trial_Details_Control_Update_Reason_Step3_13', 'Reason:', '', 'hidden'), ('', 'Address:', 'Critical Care Professorial Unit\nRoyal North Shore Hospital\nLevel 6\nSt Leonards NSW 2065', ''), ('Trial_Details_Control_Update_Value_Step3_14', 'Update:', u'', 'hidden'), ('Trial_Details_Control_Update_Reason_Step3_14', 'Reason:', '', 'hidden'), ('', 'Country:', 'Australia', ''), ('Trial_Details_Control_Update_Value_Step3_15', 'Update:', u'', 'hidden'), ('Trial_Details_Control_Update_Reason_Step3_15', 'Reason:', '', 'hidden'), ('', 'Tel:', '+61 2 95145735', ''), ('Trial_Details_Control_Update_Value_Step3_16', 'Update:', u'', 'hidden'), ('Trial_Details_Control_Update_Reason_Step3_16', 'Reason:', '', 'hidden'), ('', 'Fax:', '', ''), ('Trial_Details_Control_Update_Value_Step3_17', 'Update:', u'', 'hidden'), ('Trial_Details_Control_Update_Reason_Step3_17', 'Reason:', '', 'hidden'), ('', 'Email:', 'Sharon.McKinley@uts.edu.au', ''), ('Trial_Details_Control_Update_Value_Step3_18', 'Update:', u'', 'hidden'), ('Trial_Details_Control_Update_Reason_Step3_18', 'Reason:', '', 'hidden'), ('', 'Name:', 'Leonie Weisbrodt', ''), ('Trial_Details_Control_Update_Value_Step3_19', 'Update:', u'', 'hidden'), ('Trial_Details_Control_Update_Reason_Step3_19', 'Reason:', '', 'hidden'), ('', 'Address:', 'Intensive Care Unit\nNepean Hospital\nDerby St\nPenrith NSW 2751', ''), ('Trial_Details_Control_Update_Value_Step3_20', 'Update:', u'', 'hidden'), ('Trial_Details_Control_Update_Reason_Step3_20', 'Reason:', '', 'hidden'), ('', 'Country:', 'Australia', ''), ('Trial_Details_Control_Update_Value_Step3_21', 'Update:', u'', 'hidden'), ('Trial_Details_Control_Update_Reason_Step3_21', 'Reason:', '', 'hidden'), ('', 'Tel:', '+61 2 47341388', ''), ('Trial_Details_Control_Update_Value_Step3_22', 'Update:', u'', 'hidden'), ('Trial_Details_Control_Update_Reason_Step3_22', 'Reason:', '', 'hidden'), ('', 'Fax:', '+61 2 47343134', ''), ('Trial_Details_Control_Update_Value_Step3_23', 'Update:', u'', 'hidden'), ('Trial_Details_Control_Update_Reason_Step3_23', 'Reason:', '', 'hidden'), ('', 'Email:', 'weisbrl@wahs.nsw.gov.au', ''), ('Trial_Details_Control_Update_Value_Step3_24', 'Update:', u'', 'hidden'), ('Trial_Details_Control_Update_Reason_Step3_24', 'Reason:', '', 'hidden'), ('', 'Name:', '', ''), ('Trial_Details_Control_Update_Value_Step3_25', 'Update:', u'', 'hidden'), ('Trial_Details_Control_Update_Reason_Step3_25', 'Reason:', '', 'hidden'), ('', 'Address:', '', ''), ('Trial_Details_Control_Update_Value_Step3_26', 'Update:', u'', 'hidden'), ('Trial_Details_Control_Update_Reason_Step3_26', 'Reason:', '', 'hidden'), ('', 'Country:', '', ''), ('Trial_Details_Control_Update_Value_Step3_27', 'Update:', u'', 'hidden'), ('Trial_Details_Control_Update_Reason_Step3_27', 'Reason:', '', 'hidden'), ('', 'Tel:', '', ''), ('Trial_Details_Control_Update_Value_Step3_28', 'Update:', u'', 'hidden'), ('Trial_Details_Control_Update_Reason_Step3_28', 'Reason:', '', 'hidden'), ('', 'Fax:', '', ''), ('Trial_Details_Control_Update_Value_Step3_29', 'Update:', u'', 'hidden'), ('Trial_Details_Control_Update_Reason_Step3_29', 'Reason:', '', 'hidden'), ('', 'Email:', '', ''), ('Trial_Details_Control_Update_Value_Step3_30', 'Update:', u'', 'hidden'), ('Trial_Details_Control_Update_Reason_Step3_30', 'Reason:', '', 'hidden'), ('', u'', u'', '')]
|
7
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8
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9
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Total run time: less than 5 seconds
Total cpu time used: less than 5 seconds
Total disk space used: 19.7 KB