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

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ClinicalTrials.gov Identifier: NCT03673683
Recruitment Status : Completed
First Posted : September 17, 2018
Last Update Posted : March 20, 2020
Sponsor:
Collaborators:
Birmingham Women's and Children's NHS Foundation Trust
Royal Brompton & Harefield NHS Foundation Trust
University College, London
University of Birmingham
University of Leeds
Northern Ireland Clinical Trials Unit
University of the West of England
University of Edinburgh
Information provided by (Responsible Party):
Bronagh Blackwood, Queen's University, Belfast

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.

Condition or disease Intervention/treatment Phase
Ventilator Weaning Behavioral: SANDWICH protocol Behavioral: Usual care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10498 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Stepped wedge, cluster randomized stepped wedge clinical trial
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Sedation AND Weaning in Children: the SANDWICH Trial
Actual Study Start Date : February 5, 2018
Actual Primary Completion Date : March 10, 2020
Actual Study Completion Date : March 10, 2020

Arm Intervention/treatment
Active Comparator: Usual Care
Sedation and ventilation weaning that is non-protocol-based and primarily medically-driven.
Behavioral: Usual care
Usual sedation and weaning management that is not protocol based

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03673683


Locations
Show Show 17 study locations
Sponsors and Collaborators
Queen's University, Belfast
Birmingham Women's and Children's NHS Foundation Trust
Royal Brompton & Harefield NHS Foundation Trust
University College, London
University of Birmingham
University of Leeds
Northern Ireland Clinical Trials Unit
University of the West of England
University of Edinburgh
Investigators
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Principal Investigator: Bronagh Blackwood Queens University Belfast
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Responsible Party: Bronagh Blackwood, Professor, Queen's University, Belfast
ClinicalTrials.gov Identifier: NCT03673683    
Other Study ID Numbers: B17/13
15/04/01 ( Other Identifier: NIHR HTA )
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: March 20, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bronagh Blackwood, Queen's University, Belfast:
Invasive Mechanical Ventilation