Sedation and Weaning in Children Requiring Invasive Mechanical Ventilation

NCT03673683 | Completed DMC

• 2 other identifiers: B17/1315/04/01
• Study Type: interventional
• Target: 10,498
• Locations: 1 country
• Sites: 17

Brief 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

Keywords

Invasive Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

• Duration of Invasive Mechanical Ventilation

  Duration of Invasive Mechanical Ventilation measured in hours from initiation of invasive mechanical ventilation until the first successful extubation

  From admission until 48 hours following extubation

Secondary Outcomes (14)

• Successful Extubation

  48 hours following extubation

• Number of unplanned extubations

  From admission up to 90 days or PICU discharge whichever is earlier

• Number of reintubations

  From admission up to 90 days or PICU discharge whichever is earlier

• Total duration of Invasive mechanical ventilation

  From admission up to 90 days or PICU discharge whichever is earlier

• Non-invasive mechanical ventilation Incidence

  From admission up to 90 days or PICU discharge whichever is earlier

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

Sedation and ventilation weaning that is non-protocol-based and primarily medically-driven.

Behavioral: Usual care

SANDWICH protocol

EXPERIMENTAL

A protocol-based intervention for managing sedation and ventilation weaning.

Behavioral: SANDWICH protocol

Interventions

SANDWICH protocol BEHAVIORAL

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

SANDWICH protocol

Usual care BEHAVIORAL

Usual sedation and weaning management that is not protocol based

Usual Care

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All children (\> 16 year old) in participating PICUs receiving invasive mechanical ventilation

You may not qualify if:

• Children who would not reach the primary endpoint (tracheostomy in situ; not expected to survive; treatment withdrawal)
• Children who are pregnant, as documented in their medical notes

Sponsors & Collaborators

• Queen's University, Belfast: lead
• Birmingham Women's and Children's NHS Foundation Trust: collaborator
• Royal Brompton & Harefield NHS Foundation Trust: collaborator
• University College, London: collaborator
• University of Birmingham: collaborator
• University of Leeds: collaborator
• Northern Ireland Clinical Trials Unit: collaborator
• University of the West of England: collaborator
• University of Edinburgh: collaborator

Study Sites (17)

Belfast Health and Social Care Trust

Belfast, Co. Antrim, BT12 6BE, United Kingdom

Location

Alder Hey Children's NHS Foundation Trust

Liverpool, Merseyside, L12 2AP, United Kingdom

Location

University Hospitals of North Midlands NHS Trust

Stoke, Staffordshire, ST4 6QG, United Kingdom

Location

Birmingham Women and Children's NHS Foundation Trust

Birmingham, B4 6NH, United Kingdom

Location

University Hospital Bristol NHS Foundation Trust

Bristol, BS2 8AE, United Kingdom

Location

Cambridge University Hospitals NHS Foundation Trust

Cambridge, CB2 0QQ, United Kingdom

Location

Cardiff and Vale University Health Board

Cardiff, CF14 4XW, United Kingdom

Location

Leeds Teaching Hospitals Trust

Leeds, LS1 3EX, United Kingdom

Location

Kings College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

Location

St George's University Hospitals NHS Foundation Trust

London, SW17 0QT, United Kingdom

Location

Royal Brompton and Harefield NHS Foundation Trust

London, SW3 6NP, United Kingdom

Location

Imperial College Healthcare NHS Trust

London, W2 1NY, United Kingdom

Location

Great Ormond Street Hospital NHS Foundation Trust

London, WC1 N3JH, United Kingdom

Location

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle, NE1 4LP, United Kingdom

Location

Oxford University Hospital NHS Foundation Trust

Oxford, OX3 9DU, United Kingdom

Location

Sheffield Children's NHS Foundation Trust

Sheffield, S10 2TH, United Kingdom

Location

University Hospital Southampton Foundation NHS Trust

Southampton, SO16 6YD, United Kingdom

Location

Study Officials

• Bronagh Blackwood

  Queens University Belfast

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Stepped wedge, cluster randomized stepped wedge clinical trial

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: September 17, 2018
• Study Start: February 5, 2018
• Primary Completion: March 10, 2020
• Study Completion: March 10, 2020
• Last Updated: March 20, 2020

Record last verified: 2020-03

Locations

GB (17)