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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
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Completed NCT02946502 - Handgrip Strength Value in Predicting Mechanical Ventilation Weaning N/A
Terminated NCT03019107 - Breath Synchronized Abdominal Muscle Stimulation to Facilitate Ventilator Weaning: a Pilot Study