Sedation and Weaning in Children Requiring Invasive Mechanical Ventilation (SANDWICH)

March 19, 2020 updated by: Bronagh Blackwood, Queen's University, Belfast

Sedation AND Weaning in Children: the SANDWICH Trial

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.

Study Overview

Status

Completed

Conditions

Detailed Description

Mechanical ventilation is a common lifesaving therapy, but the longer a child remains on the ventilator, the more risk they have of developing problems. For this reason, getting the child off the ventilator (called weaning) is an important patient outcome. Sedative drugs are necessary so the child can tolerate the breathing tube, but too much can make them sleepy and delay coming off the ventilator.

In 2014, visits to 24 Paediatric Intensive Care Units (PICUs) were conducted and it was found that weaning was usually performed by doctors and occasionally senior nurses, but weaning was not always done the same way and, because everyone was not involved, it was often disjointed.

This study will determine if a coordinated approach by doctors and nurses to optimise sedation and weaning using guidelines will: (a) reduce how long patients are on a ventilator without causing any increased risk; (b) reduce the time children spend in a PICU and the hospital; (c) be cost effective in the NHS; and (d) be easily adopted by staff delivering care.

Children receiving ventilation, except those that will never come off a ventilator, will be weaned using the guidelines. Data collection will start in all PICUs at the same time from the very beginning of the study when they are weaning children according to usual practice. Each month, one unit will be chosen at random and staff will be trained to use the new guidelines. The unit will continue using the new guidelines for the rest of the trial. Outcome data collected before (usual care) and after (intervention) training will be compared. An evaluation of the process of implementing the new intervention will be undertaken. During the process evaluation, study staff will be interviewed about their experiences and views with the new approach.

Study Type

Interventional

Enrollment (Actual)

10498

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Birmingham, United Kingdom, B4 6NH
        • Birmingham Women and Children's NHS Foundation Trust
      • Bristol, United Kingdom, BS2 8AE
        • University Hospital Bristol NHS Foundation Trust
      • Cambridge, United Kingdom, CB2 0QQ
        • Cambridge University Hospitals NHS Foundation Trust
      • Cardiff, United Kingdom, CF14 4XW
        • Cardiff and Vale University Health Board
      • Leeds, United Kingdom, LS1 3EX
        • Leeds Teaching Hospitals Trust
      • London, United Kingdom, SW3 6NP
        • Royal Brompton and Harefield NHS Foundation Trust
      • London, United Kingdom, SE5 9RS
        • Kings College Hospital NHS Foundation Trust
      • London, United Kingdom, W2 1NY
        • Imperial College Healthcare NHS Trust
      • London, United Kingdom, SW17 0QT
        • St George's University Hospitals NHS Foundation Trust
      • London, United Kingdom, WC1 N3JH
        • Great Ormond Street Hospital NHS Foundation Trust
      • Newcastle, United Kingdom, NE1 4LP
        • The Newcastle upon Tyne Hospitals NHS Foundation Trust
      • Oxford, United Kingdom, OX3 9DU
        • Oxford University Hospital NHS Foundation Trust
      • Sheffield, United Kingdom, S10 2TH
        • Sheffield Children's NHS Foundation Trust
      • Southampton, United Kingdom, SO16 6YD
        • University Hospital Southampton Foundation NHS Trust
    • Co. Antrim
      • Belfast, Co. Antrim, United Kingdom, BT12 6BE
        • Belfast Health and Social Care Trust
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L12 2AP
        • Alder Hey Children's NHS Foundation Trust
    • Staffordshire
      • Stoke, Staffordshire, United Kingdom, ST4 6QG
        • University Hospitals of North Midlands NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Usual Care
Sedation and ventilation weaning that is non-protocol-based and primarily medically-driven.
Usual sedation and weaning management that is not protocol based
Experimental: SANDWICH protocol
A protocol-based intervention for managing sedation and ventilation weaning.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Invasive Mechanical Ventilation
Time Frame: From admission until 48 hours following extubation
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful Extubation
Time Frame: 48 hours following extubation
Incidence of successful extubation
48 hours following extubation
Number of unplanned extubations
Time Frame: From admission up to 90 days or PICU discharge whichever is earlier
Number of unplanned extubations
From admission up to 90 days or PICU discharge whichever is earlier
Number of reintubations
Time Frame: 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
Time Frame: 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
Time Frame: From admission up to 90 days or PICU discharge whichever is earlier
Incidence of post-extubation use of non-invasive ventilation
From admission up to 90 days or PICU discharge whichever is earlier
Non-invasive mechanical ventilation Duration
Time Frame: From admission up to 90 days or PICU discharge whichever is earlier
Duration of post-extubation use of non-invasive ventilation
From admission up to 90 days or PICU discharge whichever is earlier
Tracheostomy insertion
Time Frame: From admission up to 90 days or PICU discharge whichever is earlier
Incidence of tracheostomy insertion
From admission up to 90 days or PICU discharge whichever is earlier
Post-extubation stridor
Time Frame: From admission up to 90 days or PICU discharge whichever is earlier
Incidence of post-extubation stridor
From admission up to 90 days or PICU discharge whichever is earlier
Adverse events
Time Frame: From admission up to 90 days or PICU discharge whichever is earlier
Incidence of adverse events
From admission up to 90 days or PICU discharge whichever is earlier
PICU length of stay
Time Frame: From admission up to 90 days or PICU discharge whichever is earlier
PICU length of stay from admission to discharge measured in days
From admission up to 90 days or PICU discharge whichever is earlier
Hospital length of stay
Time Frame: From admission up to 90 days or PICU discharge whichever is earlier
Hospital length of stay from admission to discharge measured in days
From admission up to 90 days or PICU discharge whichever is earlier
ICU Mortality
Time Frame: From admission up to 90 days or PICU discharge whichever is earlier
Incidence of mortality occurring within the ICU
From admission up to 90 days or PICU discharge whichever is earlier
Hospital Mortality
Time Frame: From admission up to 90 days or PICU discharge whichever is earlier
Incidence of Mortality occurring within the hospital
From admission up to 90 days or PICU discharge whichever is earlier
Cost per respiratory complication avoided
Time Frame: 28 days
Cost per respiratory complication avoided
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2018

Primary Completion (Actual)

March 10, 2020

Study Completion (Actual)

March 10, 2020

Study Registration Dates

First Submitted

July 2, 2018

First Submitted That Met QC Criteria

September 13, 2018

First Posted (Actual)

September 17, 2018

Study Record Updates

Last Update Posted (Actual)

March 20, 2020

Last Update Submitted That Met QC Criteria

March 19, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • B17/13
  • 15/04/01 (Other Identifier: NIHR HTA)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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