Clinical trial NCT05035290: Negative Pressure Ventilation in Paediatric Patients During Weaning
Official title: Negative Pressure Ventilation in Critically Ill Paediatric Patients During Weaning: Prospective Randomized Interventional Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Weaning Failure
Keywords: Weaning
Weaning failure
Negative pressure ventilation
Cuirass
Paediatric patient
Critical care
Lead sponsor: Brno University Hospital
Sponsor class: OTHER
Collaborators: name: Masaryk University
First posted: 2021-09-05
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
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)
Primary purpose: SUPPORTIVE_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.

Eligibility criteria: 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

Primary outcomes:
measure: Early weaning failure
timeFrame: in 60 minutes after extubation
measure: Overall weaning failure
timeFrame: during 24 hours after extubation
Secondary outcomes:
measure: Blood gases trends
timeFrame: during initial 60 minutes after extubation
measure: Pulse oximetry trend
timeFrame: during initial 60 minutes after extubation
measure: Early cuirass tolerance
timeFrame: during initial 60 minutes after extubation
measure: Overall cuirass tolerance
timeFrame: during 24 hours after extubation
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Brno University Hospital
state: South Moravian Region
Study officials:
affiliation: Department of paediatric anaesthesia and intensive care medicine
name: Petr Stourac, prof. MD., Ph.D.
role: STUDY_CHAIR
References: