Sedation and Weaning in Children Requiring Invasive Mechanical Ventilation

Study Overview
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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.

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.

Official Title
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Sedation AND Weaning in Children: the SANDWICH Trial

Conditions
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Ventilator Weaning

Intervention / Treatment
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* Behavioral: SANDWICH protocol
* Behavioral: Usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Stepped wedge, cluster randomized stepped wedge clinical trial
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Invasive Mechanical Ventilation