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Weaning children from the breathing machine in the children’s intensive care unit

Sedation AND Weaning In CHildren: the SANDWICH trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16998143
Enrollment
9520
Registered
2018-03-08
Start date
2018-02-05
Completion date
Unknown
Last updated
2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute respiratory failure Respiratory

Interventions

This study will be conducted in up to 18 Paediatric Intensive Care Units (PICUs) across the UK. Each PICU will be considered a 'cluster' in this trial. All clusters will open and start the trial at th

Sponsors

Queen's University of Belfast
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All invasively mechanically ventilated children < 16 years old

Exclusion criteria

Exclusion criteria: 1. Children who would not reach the primary endpoint Added 15/05/2019: 2. Children who are pregnant, as documented in their medical notes

Design outcomes

Primary

MeasureTime frame
Duration of Invasive Mechanical Ventilation measured in hours through review of patient Intensive care charts from initiation of invasive ventilation until successful extubation (success defined as still breathing spontaneously 48 hours following extubation); Timepoint(s): 48 hours

Secondary

MeasureTime frame
1. Incidence of successful extubation is measured through review of patient intensive care charts at 48 hours following extubation 2. Number of unplanned extubations is measured through review of patient intensive care charts up to 90 days or PICU discharge 3. Number of reintubations is measured through review of patient intensive care charts up to 90 days or PICU discharge 4. Total duration of Invasive Mechanical Ventilation in hours through review of patient intensive care charts up to 90 days or discharge 5. Incidence and duration in minutes of post extubation use of non-invasive ventilation is measured through review of patient intensive care charts up to 90 days or PICU discharge 6. Incidence of tracheostomy insertion is measured through review of patient intensive care charts at 90 days or PICU discharge 7. Incidence of post-extubation Stridor is measured through review of patient intensive care charts at 90 days or PICU discharge 8. Incidence of any adverse events is measured through review of patient notes at 90 days or PICU discharge 9. PICU length of stay is measured in days through review of patient notes at PICU discharge 10. Hospital length of stay discharge is measured in days through review of patients notes at hospital discharge 11. Incidence of mortality in ICU is measured through review of the PICAnet data set at PICU discharge 12. Incidence of mortality in hospital is measured through review of patients notes at hospital discharge 13. Cost per complication avoided is measured through review of patients notes and the PICAnet dataset at 28 days

Countries

England, Northern Ireland, United Kingdom, Wales

Contacts

Public ContactRoisin Boyle
SANDWICH@nictu.hscni.net+44 (0)28 90 635794

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 20, 2026