Negative Pressure Ventilation in Paediatric Patients During Weaning

NCT05035290 | Unknown DMC

• 1 other identifier: KDAR NEGATIVE
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Weaning Failure

Keywords

Weaning; Weaning failure; Negative pressure ventilation; Cuirass; Paediatric patient; Critical care

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Blood gases trends

  during initial 60 minutes after extubation

• Pulse oximetry trend

  during initial 60 minutes after extubation

• Early cuirass tolerance

  during initial 60 minutes after extubation

• Overall cuirass tolerance

  during 24 hours after extubation

Study Arms (2)

Negative pressure ventilation

EXPERIMENTAL

Negative pressure application after extubation

Device: Negative pressure ventilation

Standard approach

NO INTERVENTION

Standard approach - oxygentherapy based on patients need

Interventions

Negative pressure ventilation DEVICE

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

Also known as: Negative pressure ventilation - cuirass

Negative pressure ventilation

Eligibility Criteria

• Age: 1 Month - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• invasive mechanical ventilation
• informed consent
• scheduled for weaning

You may not qualify if:

• neuromuscular disorder
• mechanical ventilation at home (chronic use)
• less than 24 hours after abdominal or thoracic surgery
• technical problems with the cuirass - chest drain

Sponsors & Collaborators

• Brno University Hospital: lead
• Masaryk University: collaborator

Study Sites (1)

Brno University Hospital

Brno, South Moravian, 62500, Czechia

RECRUITING

Study Officials

• Petr Stourac, prof. MD., Ph.D.

  Department of paediatric anaesthesia and intensive care medicine

  STUDY CHAIR

Central Study Contacts

Jozef Klučka, assoc.prof.MD., Ph.D.

CONTACT

532234696; klucka.jozef@fnbrno.cz

Milan Kratochvíl, MD. EDIC

CONTACT

532234696; kratochvil.milan@fnbrno.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Critically ill paediatric patients scheduled for weaning from mechanical ventilation will be randomized to interventional group (negative pressure ventilation) and control group (standard approach)

Study Record Dates

• First Submitted: August 30, 2021
• First Posted: September 5, 2021
• Study Start: February 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 24, 2023

Record last verified: 2023-03

Locations

CZ (1)