Sedation Practice in Intensive Care in Australia and New Zealand- A Pilot Study

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2011
INTERVENTION: Arm 1 Known as Grp DexP‐sedation regime with dexmedetomidine as the primary agent. Dexmedetomidine up to 1 to 1.5 mcg/kg/hour to achieve desired sedation level. Given via infusion as required for up to a max of 30 days. Arm 2 Grp Std care‐ standard care sedation as per site's normal practice. Given via infusion as required. CONDITION: Sedation in intensive care patients PRIMARY OUTCOME: a comparison of the cumulative and daily dose of administered dexmedetomidine and midazolam in the intervention and the control groups. ; This will be assessed via data collected from the medical record. SECONDARY OUTCOME: Assessment of the rate of recruitment of eligible subjects: ; a. Proportion of screened and eligible patients who were recruited. ; b. Proportion of enrolled patients who were intubated for longer than 24 hours. ; c. Duration from time of intubation to time of randomisation and time from randomisation to time of commencement of study medications. ; This will be assessed via data collected from the medical record. Composite of death or full time institutional dependency (rehabilitation hospital or nursing home). ; This will be assessed via data collected from the medical record and also patient follow up. Duration of mechanical ventilation, ICU and hospital length of stay, mechanical ventilation and ICU free days at day 28. ; This will be assessed via data collected from the medical record. The cumulative and daily dose of propofol, ketamine, fentanyl, morphine, diazepam, clonazepam and other sedatives. ; This will be assessed via data collected from the medical record. The proportion of patients in RASS categories ‐3 to ‐5, ‐2 to +1 and +2 to +4, assessed every day in ventilated patients still receiving sedative infusions. ; This will be assessed via data collected from the medical record. The proportion of patients with a positive CAM‐ICU and the number of days for which the CAM‐ICU is positive ; This will be assessed via data collected from the medical record. Vital status. ; This will be assessed via data collected from the medical record and also patient follow up. INCLUSION CRITERIA: Patients eligible for the study must meet these 2 criteria: The patient is mechanically ventilated via an endotracheal tube and has been intubated, (excluding time spent intubated within an operating or procedural theatre), for less than 12 hours, and the treating clinician believes that: 1. The patient requires immediate AND ongoing sedative medication for comfort, safety, and to facilitate the delivery of life support measures. 2. The choice of the sedative medications needs to be determined now 3. There is uncertainty whether a sedative regimen using dexmedetomidine as the primary agent or the clinicians usual choice of sedative regimen for this patient is superior, AND 4. The patient is expected to remain intubated the day after tomorrow.
Epistemonikos ID: 92002959282f1c8d92676d75e9081823b7d9277c
First added on: Aug 22, 2024