Negative Pressure Ventilation in Paediatric Patients During Weaning (NEGWEAN)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Weaning Failure
• Intervention / Treatment: Device: Negative pressure ventilation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jozef Klučka, assoc.prof.MD., Ph.D.; Phone Number: 00420 532234696; Email: klucka.jozef@fnbrno.cz
• Study Contact Backup: Name: Milan Kratochvíl, MD. EDIC; Phone Number: 00420 532234696; Email: kratochvil.milan@fnbrno.cz

Study Locations

• Czechia
  • South Moravian Region
    • Brno, South Moravian Region, Czechia, 62500
      • Recruiting
      • Brno University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Negative pressure ventilation; Negative pressure application after extubation	Device: Negative pressure ventilation; Negative pressure ventilation - cuirass will be applied on the patient´s ches and abdomen immediately after extubation; Other Names: Negative pressure ventilation - cuirass
No Intervention: Standard approach; Standard approach - oxygentherapy based on patients need

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Pulse oximetry trend	Trends of pulse oximetry during initial 60 minutes after extubation	during initial 60 minutes after extubation
Early cuirass tolerance	Incidence of the need for cuirass removal during initial 60 minutes	during initial 60 minutes after extubation
Overall cuirass tolerance	Defined by incidence of new skin lesions after cuirass application	during 24 hours after extubation

Collaborators and Investigators

• Sponsor: Brno University Hospital
• Collaborators: Masaryk University
• Investigators: Study Chair: Petr Stourac, prof. MD., Ph.D., Department of paediatric anaesthesia and intensive care medicine

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: August 30, 2021
• First Submitted That Met QC Criteria: August 30, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 23, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Weaning; Critical care; Weaning failure; Paediatric patient; Negative pressure ventilation; Cuirass
• Other Study ID Numbers: KDAR NEGATIVE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No