Sedation and Weaning in Children Requiring Invasive Mechanical Ventilation

Summary

A UK multi-centre cluster randomised controlled trial to determine if a protocol-based intervention incorporating coordinated care with greater nursing involvement to managing sedation and ventilator weaning can reduce the duration of invasive mechanical ventilation and is cost effective compared with usual care in children in Pediatric Intensive Care Units.

Conditions

• Ventilator Weaning

Interventions

BEHAVIORAL

SANDWICH protocol

A protocol based intervention incorporating co-ordinated care with greater nursing involvement; patient-relevant sedation plans linked to regular assessment using the COMFORT scale; regular assessment of ventilation parameters with a higher than usual trigger for undertaking an extubation readiness test; a spontaneous breathing trial (SBT) on low levels of respiratory support to test extubation readiness

BEHAVIORAL

Usual care

Usual sedation and weaning management that is not protocol based

Sponsors & Collaborators

• Birmingham Women's and Children's NHS Foundation Trust

  collaborator OTHER

• Royal Brompton & Harefield NHS Foundation Trust

  collaborator OTHER

• University College, London

  collaborator OTHER

• University of Birmingham

  collaborator OTHER

• University of Leeds

  collaborator OTHER

• Northern Ireland Clinical Trials Unit

  collaborator OTHER

• University of the West of England

  collaborator OTHER

• University of Edinburgh

  collaborator OTHER

• Queen's University, Belfast

  lead OTHER

Principal Investigators

• Bronagh Blackwood · Queens University Belfast

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

SEQUENTIAL

Eligibility

Max Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-02-05

Primary Completion

2020-03-10

Completion

2020-03-10

Countries

• United Kingdom

Study Locations