Weaning Failure
Conditions
Keywords
Weaning, Weaning failure, Negative pressure ventilation, Cuirass, Paediatric patient, Critical care
Brief summary
Negative pressure ventilation (NPV) represent a unique form of noninvasive ventilation using negative pressure by specialized cuirass, that evolve negative pressure on the front size of chest and partially abdomen and facilitate the spontaneous breathing. The benefit of NPV beside noninvasive application, is the supreme tolerance of the patient (compared to other forms of noninvasive ventilation - mask, helmet), without the negative impact on enteral feeding tolerance and with the possibility of active physiotherapy. NPV could be even combined with oxygentherapy or noninvasive positive pressure ventilation. NPV in paediatric patients after extubation could be associated with reduced incidence of weaning failure.
Detailed description
After ethics committee approval and informed consent from legal guardians and fulfilling inclusion criteria, critically ill paediatric patients scheduled for weaning will be randomized (in 1:1 allocation) to NPV (interventional group) or standard approach (without NPV) after extubation. NPV in paediatric patients after extubation could be associated with reduced incidence of weaning failure. The initial setting on NPV will be: negative pressure set to -10cmH2O and will proceed for minimal time of 60 minutes after extubation (will proceed longer in case of good tolerance). In case of hypoxaemia, additional oxygentherapy will be administered according to the patients condition Primary outcome will be defined as postextubation failure incidence at 60 minutes after extubation (defined as need of noninvasive positive pressure ventilation, intubation, or high-flow oxygen therapy) and the overall incidence of weaning failure during initial 24 hour after extubation. The secondary outcome will be the dynamics of blood gases (arterial or capillary blood sample) during initial 60 minutes after extubation (1. extubation, 2. 60 minutes after extubation) and the need of and amount of artificial oxygentherapy (litres of oxygen per minute, pulse oximetry). Another outcome will be the overall cuirass tolerance after 60 minutes and after 24 hours defined by incidence of skin lesions.
Interventions
Negative pressure ventilation - cuirass will be applied on the patient´s ches and abdomen immediately after extubation
Sponsors
Masaryk University
Brno University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Critically ill paediatric patients scheduled for weaning from mechanical ventilation will be randomized to interventional group (negative pressure ventilation) and control group (standard approach)
Eligibility
Sex/Gender
ALL
Age
1 Months to 19 Years
Healthy volunteers
No
Inclusion criteria
* invasive mechanical ventilation * informed consent * scheduled for weaning
Exclusion criteria
* neuromuscular disorder * mechanical ventilation at home (chronic use) * less than 24 hours after abdominal or thoracic surgery * technical problems with the cuirass - chest drain
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early weaning failure | in 60 minutes after extubation | Incidence of early weaning failure - intubation, noninvasive positive pressure ventilation, high flow oxygen therapy |
| Overall weaning failure | during 24 hours after extubation | Incidence of weaning failure - intubation, noninvasive positive pressure ventilation, high flow oxygen therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood gases trends | during initial 60 minutes after extubation | Trends of blood gases (CO2 and O2) in arterial or capillary blood samples drown at the extubation and in 60 minutes after extubation |
| Pulse oximetry trend | during initial 60 minutes after extubation | Trends of pulse oximetry during initial 60 minutes after extubation |
| Early cuirass tolerance | during initial 60 minutes after extubation | Incidence of the need for cuirass removal during initial 60 minutes |
| Overall cuirass tolerance | during 24 hours after extubation | Defined by incidence of new skin lesions after cuirass application |
Countries
Czechia
Contacts
Primary ContactJozef Klučka, assoc.prof.MD., Ph.D.
Backup ContactMilan Kratochvíl, MD. EDIC
Outcome results
None listed