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Completed

NCT Number: NCT03673683

Sedation and Weaning in Children Requiring Invasive Mechanical Ventilation

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.

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Key information

Conditions

Age range

Up to 16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Belfast Health and Social Care Trust, Belfast, Co. Antrim, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Usual Care

Behavioral

Usual sedation and weaning management that is not protocol based

Primary outcomes

  1. 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

Secondary outcomes

  1. Successful Extubation

    Time frame: 48 hours following extubation

    Incidence of successful extubation

  2. Number of unplanned extubations

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

    Number of unplanned extubations

  3. Number of reintubations

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

    Number of reintubations

  4. 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

  5. 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

  6. 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

  7. Tracheostomy insertion

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

    Incidence of tracheostomy insertion

  8. Post-extubation stridor

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

    Incidence of post-extubation stridor

  9. Adverse events

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

    Incidence of adverse events

  10. 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

  11. 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

  12. ICU Mortality

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

    Incidence of mortality occurring within the ICU

  13. Hospital Mortality

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

    Incidence of Mortality occurring within the hospital

  14. Cost per respiratory complication avoided

    Time frame: 28 days

    Cost per respiratory complication avoided

Sponsors and collaborators

Lead sponsor

Queen's University, Belfast

Other

Collaborators

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

Registry information

Official study title

Sedation AND Weaning in Children: the SANDWICH Trial

Acronym: SANDWICH

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 17, 2018
Registry last updated
Mar 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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