Negative Pressure Ventilation in Paediatric Patients During Weaning (NEGWEAN)

March 23, 2023 updated by: Petr Štourač, MD, Brno University Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Early weaning failure
Time Frame: in 60 minutes after extubation
Incidence of early weaning failure - intubation, noninvasive positive pressure ventilation, high flow oxygen therapy
in 60 minutes after extubation
Overall weaning failure
Time Frame: during 24 hours after extubation
Incidence of weaning failure - intubation, noninvasive positive pressure ventilation, high flow oxygen therapy
during 24 hours after extubation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood gases trends
Time Frame: during initial 60 minutes after extubation
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
Time Frame: during initial 60 minutes after extubation
Trends of pulse oximetry during initial 60 minutes after extubation
during initial 60 minutes after extubation
Early cuirass tolerance
Time Frame: during initial 60 minutes after extubation
Incidence of the need for cuirass removal during initial 60 minutes
during initial 60 minutes after extubation
Overall cuirass tolerance
Time Frame: during 24 hours after extubation
Defined by incidence of new skin lesions after cuirass application
during 24 hours after extubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brno University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Masaryk University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Petr Stourac, prof. MD., Ph.D., Department of paediatric anaesthesia and intensive care medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 30, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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