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Ventilator WeaningNCT04011852

The Role of Chest Electrical Impedance Tomography in the Pediatric Ventilator Weaning

An observational study of Ventilator Weaning and Child, run by University of Sao Paulo General Hospital at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To correlate the data obtained by Electrical impedance tomography (EIT) during the spontaneous breathing trials (SBT) on a T-piece, in children, with failure in the trial and Extubation failure. Observe if the EIT monitoring will be able to detect the children that will fail earlier than the SBT performed alone. Read more about this study

Who is it for?
Ages 28 days to 15 years
What is being tested?
Electrical Impedance tomography
Type of treatment
Medical device
How many people
83 participants
Where
1 siteBrazil
Study dates
26 Sep 2019to 30 Nov 2023
How long will I take part?
2 Years
Phase
Observational
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 28 days to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Children who are on mechanical ventilation for a period of more than 24 hours, between 28 days of age and 15 years, who are admitted to the pediatric intensive care unit (ICU) of the Children's Institute in Brazil and are ready for a weaning trial.

Who may be able to join

  • Children who are on mechanical ventilation for a period of more than 24 hours, between 28 days of age and 15 years, who are admitted to the pediatric intensive care unit (ICU) of the Children's Institute in Brazil

Who cannot join

  • Upper Airway Obstruction
  • Diaphragmatic hernia or diaphragmatic paralysis
  • Chronic use of mechanical ventilation
  • Cyanogenic congenital heart disease
  • Primary pulmonary hypertension
  • Neuromuscular disease
  • Tracheostomy

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • University of São Paulo General Hospital

    São Paulo, São Paulo

Other trials in Brazil

About this study

To correlate the data obtained by Electrical impedance tomography (EIT) during the spontaneous breathing trials (SBT) on a T-piece, in children, with failure in the trial and Extubation failure.

Observe if the EIT monitoring will be able to detect the children that will fail earlier than the SBT performed alone.

Method: A cross-sectional, prospective study to explore the potential benefits of monitoring with EIT during weaning.

Read the detailed description

Early and successful Extubation is sometimes a difficult combination in children, since the criteria for suggesting it are often subjective and poorly defined. Electrical impedance tomography (EIT) has been developed and used clinically for more than 30 years. Interest in this technology arose from the need to monitor ventilation and pulmonary perfusion at the bedside. Because it is a non-invasive and non-radiation technology, EIT is very promising in the pediatric population. Objectives: To correlate the data obtained by the EIT during the spontaneous breathing trials (SBT) on a T-piece with failure in the trial and Extubation failure and to observe if the EIT is able to detect the children that will fail earlier than the SBT performed alone. Method: A cross-sectional, prospective study to explore the potential benefits of monitoring with EIT during weaning. Qualitative characteristics will be described using absolute and relative frequencies and the quantitative characteristics will be described using summary measures (mean, standard deviation, median, minimum and maximum). Bivariate and later multiple logistic regression analyzes will be performed to evaluate the influence of characteristics assessed on weaning failure, mainly the reduction in functional residual capacity during and after the weaning trial. For the analysis will be used the software IBM-SPSS for Windows version 20.0 and tabulation of the data will be used Microsoft Excel 2010 software. The tests will be performed with significance level of 5%.

Being tested
Electrical Impedance tomography
Keywords
Ventilator Weaning, Child, Electrical Impedance Tomography, Respiration, artificial, Intensive Care units
Medical subject headings
Respiratory Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electrical Impedance tomographyDevice

    Monitoring with Electrical impedance tomography during spontaneous breathing trials on T-piece in children

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correlate Electrical impedance tomography to Extubation failure

    Compare data obtained by the EIT during the spontaneous breathing trial with Extubation failure

    Measured: 48 hours

  2. Correlate Electrical impedance tomography to spontaneous breathing trial failure

    Observe if Electrical impedance tomography detects children who will fail in spontaneous breathing trial (during a 1-hour T-piece) earlier than clinical criteria

    Measured: 1 hour

Secondary outcomes (2)

  1. Electrical impedance tomography Security

    Evaluate Electrical impedance tomography Security (skin lesion or pain)

    Neonatal Skin Condition Score

    Dryness

    1. Normal, no sign of dry skin
    2. Dry skin, visible scaling
    3. Very dry skin, cracking/fissures

    Erythema

    1. No evidence of erythema
    2. Visible erythema, < 50% body surface
    3. Visible erythema, ≥ 50% body surface

    Breakdown

    1. None evident
    2. Small, localized areas
    3. Extensive

    Note:

    Perfect score = 3 Worst score = 9

    Measured: 2 hours

  2. Compare tidal volume and RR / VT index with Z-delta and RR / Z-delta

    Verify whether traditional measures of tidal volume and the RR / VT index can be independently and accurately assessed through the measurement of Z-delta and RR / Z-delta, through the Electrical impedance tomography.

    Measured: 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2019
  2. Study start26 Sep 2019
  3. Primary completion30 Nov 2023
  4. Study completion30 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
83 participants (actual)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04011852
Sponsor's protocol ID
10055719.0.0000.0068
Status last verified
Nov 2023
First submitted
3 Jul 2019
Last updated
8 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Ventilator Weaning and Child, run by University of Sao Paulo General Hospital at 1 site in Brazil.

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 1 inclusion and 7 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: finished, as of the sponsor's last update on 8 Dec 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 Brazil. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlate Electrical impedance tomography to Extubation failure (time frame: 48 hours). 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?

On the ClinicalTrials.gov record for NCT04011852.

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 8 Dec 2023.

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