Negative Pressure Ventilation in Paediatric Patients During Weaning

Study Overview
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Brief Summary
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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
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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.

Official Title
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Negative Pressure Ventilation in Critically Ill Paediatric Patients During Weaning: Prospective Randomized Interventional Trial

Conditions
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Weaning Failure

Intervention / Treatment
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* Device: Negative pressure ventilation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional 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)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Negative pressure ventilation<br>Negative pressure application after extubation | Device: Negative pressure ventilation<br>* Negative pressure ventilation - cuirass will be applied on the patient´s ches and abdomen immediately after extubation<br>* Other names: Negative pressure ventilation - cuirass;|
| No Intervention: Standard approach<br>Standard approach - oxygentherapy based on patients need | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early weaning failure | Incidence of early weaning failure - intubation, noninvasive positive pressure ventilation, high flow oxygen therapy | in 60 minutes after extubation | 
| Overall weaning failure | Incidence of weaning failure - intubation, noninvasive positive pressure ventilation, high flow oxygen therapy | during 24 hours after extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood gases trends | Trends of blood gases (CO2 and O2) in arterial or capillary blood samples drown at the extubation and in 60 minutes after extubation | during initial 60 minutes after extubation | 
| Pulse oximetry trend | Trends of pulse oximetry during initial 60 minutes after extubation | during initial 60 minutes after extubation | 
| Early cuirass tolerance | Incidence of the need for cuirass removal during initial 60 minutes | during initial 60 minutes after extubation | 
| Overall cuirass tolerance | Defined by incidence of new skin lesions after cuirass application | during 24 hours after extubation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weaning, Weaning failure, Negative pressure ventilation, Cuirass, Paediatric patient, Critical care