Sedation and Weaning in Children Requiring Invasive Mechanical Ventilation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10498 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-05

Study Completion Date

2020-03-10

Brief Summary

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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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Detailed Description

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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.

Conditions

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Ventilator Weaning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Stepped wedge, cluster randomized stepped wedge clinical trial

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Usual Care

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

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type BEHAVIORAL

Usual sedation and weaning management that is not protocol based

SANDWICH protocol

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

Group Type EXPERIMENTAL

SANDWICH protocol

* 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

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No