Negative Pressure Ventilation in Paediatric Patients During Weaning (NEGWEAN)

Brno University Hospital

Status: Enrolling

Conditions: Weaning Failure

Treatments: Device: Negative pressure ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT05035290

KDAR NEGATIVE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 1 month to 19 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Negative pressure ventilation

Experimental group

Description:

Negative pressure application after extubation

Treatment:

Device: Negative pressure ventilation

Standard approach

No Intervention group

Description:

Standard approach - oxygentherapy based on patients need