Sedation Practice in Intensive Care: A randomised controlled pilot study

Phase 2

• Conditions: Anaesthesiology - Anaesthetics; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation; Public Health - Epidemiology; Sedation in patients mechanically ventilated in paediatric intensive care

• Registration Number: ACTRN12614000225617
• Lead Sponsor: Australia and NewZealand Intensive Care-Research Centre (ANZIC-RC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Children requiring sedation to facilitate mechanical ventilation in intensive care.
Subject has been mechanically ventilated for less than 12 hours
Patient is expected to remain mechanically ventilated for more than 24 hours

Exclusion Criteria

Age 16 years or older
Proven or suspected acute primary brain lesion that may result in global impairment of conscious level or cognition, such as traumatic brain injury, intracranial haemorrhage, intracranial infection or hypoxic brain injury.
Proven or suspected neurological injury or pathology that may result in permanent or prolonged weakness of upper and lower limbs.
Burn injuries
Receiving or expected to need continuous neuromuscular blockade
Allergy to dexmedetomidine
Cardiovascular instability as manifested by any of the following:
a.Mean arterial blood (MAP) pressure less than 2 standard deviations below the normal mean for age despite resuscitation and vasopressor therapy
b.Heart rate (HR) less than 2 standard deviations below normal for age
c.Atrio-ventricular block (2nd or 3rd degree) in the absence of a functioning pacemaker
End stage liver failure or acute fulminant hepatic failure
A history of a chronic brain process that has resulted in severe global impairment of conscious level or cognition, and may include CP, metabolic conditions, and progressive neurological disorders
Patient is on ECLS
Death is deemed imminent and inevitable
There is an underlying disease that makes survival to 90 days unlikely

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure for the pilot study is to demonstrate separation between the intervention group (GpDex) and a ‘wild-type’ (usual practice) control group (GpStd) with respect to the proportion of patients achieving light sedation (SBS -1 to +1) in the first 48 hours of sedation in intensive care<br>The primary outcome will be assessed by comparing the proportion of patients in light sedation in the intervention group comparted to the proportion of patients in light sedation in the comparator group.[48 hours]