Negative Pressure Ventilation in Paediatric Patients During Weaning

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2023-12-31

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.

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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.

Conditions

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Weaning Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Negative pressure ventilation

Negative pressure application after extubation

Group Type EXPERIMENTAL

Negative pressure ventilation

Intervention Type DEVICE

Negative pressure ventilation - cuirass will be applied on the patient´s ches and abdomen immediately after extubation

Standard approach

Standard approach - oxygentherapy based on patients need

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Negative pressure ventilation

Negative pressure ventilation - cuirass will be applied on the patient´s ches and abdomen immediately after extubation

Intervention Type DEVICE

Other Intervention Names

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Negative pressure ventilation - cuirass

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

Minimum Eligible Age

1 Month

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No