SANDWICH Trial

Trial Acronym SANDWICH
Clinical Area Paediatric Critical Care
Description Sedation AND Weaning In CHildren
Status Open
RECRUITMENT
Date Opened to Recruitment February 2018 – October 2019
Target Recruitment 9520
Recruitment to date 10029 as of 02/10/2019
Date Closed to Recruitment
No. of Sites 17
TRIAL DESIGN
Trial Design Prospective, cluster-randomised stepped wedge (SW) multi-centre clinical and cost-effectiveness trial with an internal pilot and a process evaluation.
Study Aim The aim of this study is to determine if a protocol-based intervention for the management of children in intensive care units can reduce the duration of invasive mechanical ventilation (IMV). The study involves co-ordinated care and greater nursing involvement in the sedation and ventilator weaning of children. It will also assess cost effectiveness compared with usual care.

Alongside the trial a process evaluation will be conducted using the principles of the Medical Research Council (MRC).

CHIEF INVESTIGATOR (CI)
Chief Investigator Professor Bronagh Blackwood
SPONSOR(s) & FUNDER(s)
Sponsors Queen’s University Belfast
Funder NIHR Health Technology Assessment Programme (HTA)