Sedation and Weaning in Children Requiring Invasive Mechanical Ventilation

Ventilator Weaning Clinical Trial

— SANDWICH  

Official title:

Sedation AND Weaning in Children: the SANDWICH Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03673683
• Other study ID #: B17/13
• Secondary ID: 15/04/01
• Status: Completed
• Phase: N/A
• Start date: February 5, 2018
• Est. completion date: March 10, 2020

Study information

• Verified date: March 2020
• Source: Queen's University, Belfast
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10498
• Est. completion date: March 10, 2020
• Est. primary completion date: March 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Ventilator Weaning

Intervention

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
• Usual care
Usual sedation and weaning management that is not protocol based

Locations

Country	Name	City	State
United Kingdom	Belfast Health and Social Care Trust	Belfast	Co. Antrim
United Kingdom	Birmingham Women and Children's NHS Foundation Trust	Birmingham
United Kingdom	University Hospital Bristol NHS Foundation Trust	Bristol
United Kingdom	Cambridge University Hospitals NHS Foundation Trust	Cambridge
United Kingdom	Cardiff and Vale University Health Board	Cardiff
United Kingdom	Leeds Teaching Hospitals Trust	Leeds
United Kingdom	Alder Hey Children's NHS Foundation Trust	Liverpool	Merseyside
United Kingdom	Great Ormond Street Hospital NHS Foundation Trust	London
United Kingdom	Imperial College Healthcare NHS Trust	London
United Kingdom	Kings College Hospital NHS Foundation Trust	London
United Kingdom	Royal Brompton and Harefield NHS Foundation Trust	London
United Kingdom	St George's University Hospitals NHS Foundation Trust	London
United Kingdom	The Newcastle upon Tyne Hospitals NHS Foundation Trust	Newcastle
United Kingdom	Oxford University Hospital NHS Foundation Trust	Oxford
United Kingdom	Sheffield Children's NHS Foundation Trust	Sheffield
United Kingdom	University Hospital Southampton Foundation NHS Trust	Southampton
United Kingdom	University Hospitals of North Midlands NHS Trust	Stoke	Staffordshire

Sponsors (9)

Lead Sponsor	Collaborator
Queen's University, Belfast	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

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Successful Extubation	Incidence of successful extubation	48 hours following extubation
Secondary	Number of unplanned extubations	Number of unplanned extubations	From admission up to 90 days or PICU discharge whichever is earlier
Secondary	Number of reintubations	Number of reintubations	From admission up to 90 days or PICU discharge whichever is earlier
Secondary	Total duration of Invasive mechanical ventilation	Total duration of Invasive mechanical ventilation	From admission up to 90 days or PICU discharge whichever is earlier
Secondary	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
Secondary	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
Secondary	Tracheostomy insertion	Incidence of tracheostomy insertion	From admission up to 90 days or PICU discharge whichever is earlier
Secondary	Post-extubation stridor	Incidence of post-extubation stridor	From admission up to 90 days or PICU discharge whichever is earlier
Secondary	Adverse events	Incidence of adverse events	From admission up to 90 days or PICU discharge whichever is earlier
Secondary	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
Secondary	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
Secondary	ICU Mortality	Incidence of mortality occurring within the ICU	From admission up to 90 days or PICU discharge whichever is earlier
Secondary	Hospital Mortality	Incidence of Mortality occurring within the hospital	From admission up to 90 days or PICU discharge whichever is earlier
Secondary	Cost per respiratory complication avoided	Cost per respiratory complication avoided	28 days