Weaning FailureNEGWEANNCT05035290
Negative Pressure Ventilation in Paediatric Patients During Weaning
A study testing Negative pressure ventilation in people with Weaning Failure, run by Brno University Hospital at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 1 month to 19 years
- Conditions the study is for
- Weaning Failure
- What is being tested?
- Negative pressure ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Feb 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- invasive mechanical ventilation
- informed consent
- scheduled for weaning
Who cannot join
- neuromuscular disorder
- mechanical ventilation at home (chronic use)
- less than 24 hours after abdominal or thoracic surgery
- technical problems with the cuirass - chest drain
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Brno University Hospital
Brno, South Moravian, 62500
Petr Štourač, doc.MD.P.hD., 532234404 ext. 00420, stourac.petr@fnbrno.cz
Jozef Klučka, MD, 532234696 ext. 00420, klucka.jozef@fnbrno.cz
About this study
Official title: 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.
Read the 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.
- Conditions
- Weaning Failure
- Being tested
- Negative pressure ventilation
- Keywords
- Weaning, Weaning failure, Negative pressure ventilation, Cuirass, Paediatric patient, Critical care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative pressure ventilationDevice
Also called Negative pressure ventilation - cuirass
Negative pressure ventilation - cuirass will be applied on the patient´s ches and abdomen immediately after extubation
| Study group | Role | What they receive |
|---|---|---|
| Negative pressure ventilation | Experimental | Negative pressure application after extubation Receives: Device: Negative pressure ventilation |
| Standard approach | No intervention | Standard approach - oxygentherapy based on patients need |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early weaning failure
Incidence of early weaning failure - intubation, noninvasive positive pressure ventilation, high flow oxygen therapy
Measured: in 60 minutes after extubation
Overall weaning failure
Incidence of weaning failure - intubation, noninvasive positive pressure ventilation, high flow oxygen therapy
Measured: during 24 hours after extubation
Secondary outcomes (4)
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
Measured: during initial 60 minutes after extubation
Pulse oximetry trend
Trends of pulse oximetry during initial 60 minutes after extubation
Measured: during initial 60 minutes after extubation
Early cuirass tolerance
Incidence of the need for cuirass removal during initial 60 minutes
Measured: during initial 60 minutes after extubation
Overall cuirass tolerance
Defined by incidence of new skin lesions after cuirass application
Measured: during 24 hours after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start1 Feb 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weaning FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Critically ill paediatric patients scheduled for weaning from mechanical ventilation will be randomized to interventional group (negative pressure ventilation) and control group (standard approach)
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Masaryk University
- Responsible party
- Principal investigator, Petr Štourač, MD, Brno University Hospital
- Investigators
- Petr Stourac, prof. MD., Ph.D., Study chair, Department of paediatric anaesthesia and intensive care medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05035290
- Sponsor's protocol ID
- KDAR NEGATIVE
- Acronym
- NEGWEAN
- Status last verified
- Mar 2023
- First submitted
- 30 Aug 2021
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Negative Pressure Ventilation in Critically Ill Paediatric Patients During Weaning: Prospective Randomized Interventional Trial
- ClinicalTrials.gov ID
- NCT05035290
- Acronym / sponsor ID
- NEGWEAN / KDAR NEGATIVE
- Conditions
- Weaning Failure
- Keywords
- Weaning, Weaning failure, Negative pressure ventilation, Cuirass, Paediatric patient, Critical care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Collaborators
- Masaryk University
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Critically ill paediatric patients scheduled for weaning from mechanical ventilation will be randomized to interventional group (negative pressure ventilation) and control group (standard approach)
| Arm | Type | Receives |
|---|---|---|
| Negative pressure ventilation | Experimental | Device: Negative pressure ventilationNegative pressure application after extubation |
| Standard approach | No intervention | –Standard approach - oxygentherapy based on patients need |
Who may qualify
- Ages
- 1 month to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- invasive mechanical ventilation
- informed consent
- scheduled for weaning
Key exclusion criteria (4 listed)
- neuromuscular disorder
- mechanical ventilation at home (chronic use)
- less than 24 hours after abdominal or thoracic surgery
- technical problems with the cuirass - chest drain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Negative pressure ventilationAlso: Negative pressure ventilation - cuirassNegative pressure ventilation - cuirass will be applied on the patient´s ches and abdomen immediately after extubation | Device | Negative pressure ventilation |
Primary outcome
Early weaning failure
Time frame: in 60 minutes after extubation
Incidence of early weaning failure - intubation, noninvasive positive pressure ventilation, high flow oxygen therapy
Overall weaning failure
Time frame: during 24 hours after extubation
Incidence of weaning failure - intubation, noninvasive positive pressure ventilation, high flow oxygen therapy
4 secondary outcomes
Blood gases trends
Time frame: during initial 60 minutes after extubation
Pulse oximetry trend
Time frame: during initial 60 minutes after extubation
Early cuirass tolerance
Time frame: during initial 60 minutes after extubation
Overall cuirass tolerance
Time frame: during 24 hours after extubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petr Stourac, prof. MD., Ph.D. study chair
Department of paediatric anaesthesia and intensive care medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative pressure ventilation in people with Weaning Failure, run by Brno University Hospital at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jozef Klučka, assoc.prof.MD., Ph.D. (532234696 ext. 00420, klucka.jozef@fnbrno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early weaning failure (time frame: in 60 minutes after extubation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.