Negative Pressure Ventilation in Paediatric Patients During Weaning
- Conditions
- Weaning Failure
- Interventions
- Device: Negative pressure ventilation
- Registration Number
- NCT05035290
- Lead Sponsor
- Brno University Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- invasive mechanical ventilation
- informed consent
- scheduled for weaning
- neuromuscular disorder
- mechanical ventilation at home (chronic use)
- less than 24 hours after abdominal or thoracic surgery
- technical problems with the cuirass - chest drain
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Negative pressure ventilation Negative pressure ventilation Negative pressure application after extubation
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Overall cuirass tolerance during 24 hours after extubation Defined by incidence of new skin lesions after cuirass application
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
Early cuirass tolerance during initial 60 minutes after extubation Incidence of the need for cuirass removal during initial 60 minutes
Pulse oximetry trend during initial 60 minutes after extubation Trends of pulse oximetry during initial 60 minutes after extubation
Trial Locations
- Locations (1)
Brno University Hospital
🇨🇿Brno, South Moravian Region, Czechia