Negative Pressure Ventilation in Paediatric Patients During Weaning

Weaning Failure Clinical Trial

— NEGWEAN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05035290
• Other study ID #: KDAR NEGATIVE
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Brno University Hospital
• Contact: Jozef Klucka, assoc.prof.MD., Ph.D.
• Phone: 532234696
• Email: klucka.jozef[@]fnbrno.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Weaning Failure

Intervention

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

Locations

Country	Name	City	State
Czechia	Brno University Hospital	Brno	South Moravian Region

Sponsors (2)

Lead Sponsor	Collaborator
Brno University Hospital	Masaryk University

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early weaning failure	Incidence of early weaning failure - intubation, noninvasive positive pressure ventilation, high flow oxygen therapy	in 60 minutes after extubation
Primary	Overall weaning failure	Incidence of weaning failure - intubation, noninvasive positive pressure ventilation, high flow oxygen therapy	during 24 hours after extubation
Secondary	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
Secondary	Pulse oximetry trend	Trends of pulse oximetry during initial 60 minutes after extubation	during initial 60 minutes after extubation
Secondary	Early cuirass tolerance	Incidence of the need for cuirass removal during initial 60 minutes	during initial 60 minutes after extubation
Secondary	Overall cuirass tolerance	Defined by incidence of new skin lesions after cuirass application	during 24 hours after extubation