Status:
COMPLETED
WOB and Paediatric Mechanical Ventilation
Lead Sponsor:
University Medical Center Groningen
Conditions:
Pediatric Respiratory Diseases
Ventilator Weaning
Eligibility:
All Genders
Up to 5 years
Phase:
NA
Brief Summary
Rationale: The most common approach to weaning infants and children is gradual reduction of ventilatory support ("traditional approach"). Alternatively, another approach to weaning is attempted with a...
Detailed Description
1. INTRODUCTION AND RATIONALE The need for mechanical ventilation for respiratory failure is one the most common indications for children to be admitted to a centralized paediatric intensive care unit...
Eligibility Criteria
Inclusion
- aged 0 to 5 years with or without lung pathology admitted to the paediatric intensive care unit are eligible for inclusion
- mechanical ventilation for at least 48 hours before the start of weaning
- weight ≥ 3 kg
- deemed eligible for weaning by the attending physician, i.e. able to initiate and maintain spontaneous breathing.
- stable haemodynamics, defined by the absence of need for increase in vaso-active drugs and/or fluid challenges at least 6 hours prior to enrolment
Exclusion
- mechanical ventilation less than 48 hours for unplanned admissions before the start of weaning
- post-operative admission with expected duration of mechanical ventilaton less than 48 hours
- not eligible for weaning as assessed by the attending physician (usually when there are unstable ventilator settings, defined by the need for increase of inspiratory pressures or positive end-expiratory pressure, and a FiO2 \> 0.6 within 6 hours prior to enrolment)
- unstable haemodynamics, defined by the need for increase in vaso-active drugs and/or fluid challenges within 6 hours prior to enrolment
- admitted to the neonatal intensive care unit
- premature birth with gestational age corrected for post-conceptional age less than 40 weeks
- congenital or acquired neuromuscular disorders
- congenital or acquired central nervous system disorders with depressed respiratory drive
- severe traumatic brain injury (i.e. Glasgow Coma Scale \< 8)
- congenital or acquired damage to the phrenic nerve
- congenital or acquired paralysis of the diaphragm
- use of neuromuscular blockade prior to enrolment
- uncorrected congenital heart disorder
- chronic lung disease
- severe pulmonary hypertension
Key Trial Info
Start Date :
November 29 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 5 2019
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05254691
Start Date
November 29 2017
End Date
February 5 2019
Last Update
February 24 2022
Active Locations (1)
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1
Beatrix Children's Hospital, University Medical Center Groningen
Groningen, Netherlands, 9700 RB