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

Q

Queen's University Belfast

Status

Completed

Conditions

Ventilator Weaning

Treatments

Behavioral: SANDWICH protocol
Behavioral: Usual care

Study type

Interventional

Funder types

Other

Identifiers

NCT03673683
B17/13
15/04/01 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

10,498 patients

Sex

All

Ages

Under 16 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

10,498 participants in 2 patient groups

Usual Care
Active Comparator group
Description:
Sedation and ventilation weaning that is non-protocol-based and primarily medically-driven.
Treatment:
Behavioral: Usual care
SANDWICH protocol
Experimental group
Description:
A protocol-based intervention for managing sedation and ventilation weaning.
Treatment:
Behavioral: SANDWICH protocol

Trial contacts and locations

17

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Data sourced from clinicaltrials.gov

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