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出境医 / 临床实验 / The Role of Chest Electrical Impedance Tomography in the Pediatric Ventilator Weaning

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

Study Description
Brief 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.

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


Condition or disease Intervention/treatment
Ventilator Weaning Child Spontaneous Breathing Trial Electrical Impedance Tomography Device: Electrical Impedance tomography

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%.
Study Design
Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 134 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: The Role of Chest Electrical Impedance Tomography in the Pediatric Ventilator Weaning
Estimated Study Start Date : September 24, 2019
Estimated Primary Completion Date : September 4, 2020
Estimated Study Completion Date : September 4, 2021
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Correlate Electrical impedance tomography to Extubation failure [ Time Frame: 48 hours ]
    Compare data obtained by the EIT during the spontaneous breathing trial with Extubation failure

  2. Correlate Electrical impedance tomography to spontaneous breathing trial failure [ Time Frame: 1 hour ]
    Observe if Electrical impedance tomography detects children who will fail in spontaneous breathing trial (during a 1-hour T-piece) earlier than clinical criteria


Secondary Outcome Measures :
  1. Electrical impedance tomography Security [ Time Frame: 2 hours ]

    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


  2. Compare tidal volume and RR / VT index with Z-delta and RR / Z-delta [ Time Frame: 1 hour ]
    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.


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date July 3, 2019
First Posted Date July 9, 2019
Last Update Posted Date September 26, 2019
Estimated Study Start Date September 24, 2019
Estimated Primary Completion Date September 4, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 3, 2019)
  • Correlate Electrical impedance tomography to Extubation failure [ Time Frame: 48 hours ]
    Compare data obtained by the EIT during the spontaneous breathing trial with Extubation failure
  • Correlate Electrical impedance tomography to spontaneous breathing trial failure [ Time Frame: 1 hour ]
    Observe if Electrical impedance tomography detects children who will fail in spontaneous breathing trial (during a 1-hour T-piece) earlier than clinical criteria
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 19, 2019)
  • Electrical impedance tomography Security [ Time Frame: 2 hours ]
    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
  • Compare tidal volume and RR / VT index with Z-delta and RR / Z-delta [ Time Frame: 1 hour ]
    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.
Original Secondary Outcome Measures
 (submitted: July 3, 2019)
  • Electrical impedance tomography Security [ Time Frame: 2 hours ]
    Evaluate Electrical impedance tomography Security (skin lesion or pain)
  • Compare tidal volume and RR / VT index with Z-delta and RR / Z-delta [ Time Frame: 1 hour ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Role of Chest Electrical Impedance Tomography in the Pediatric Ventilator Weaning
Official Title The Role of Chest Electrical Impedance Tomography in the Pediatric Ventilator Weaning
Brief 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.

Method: A cross-sectional, prospective study to explore the potential benefits of monitoring with EIT during weaning.
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%.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 2 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
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.
Condition
  • Ventilator Weaning
  • Child
  • Spontaneous Breathing Trial
  • Electrical Impedance Tomography
Intervention Device: Electrical Impedance tomography
Monitoring with Electrical impedance tomography during spontaneous breathing trials on T-piece in children
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 3, 2019) 		134
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 4, 2021
Estimated Primary Completion Date September 4, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Upper Airway Obstruction
  • Diaphragmatic hernia or diaphragmatic paralysis
  • Chronic use of mechanical ventilation
  • Cyanogenic congenital heart disease
  • Primary pulmonary hypertension
  • Neuromuscular disease
  • Tracheostomy
Sex/Gender
Sexes Eligible for Study: All
Ages up to 15 Years   (Child)
Accepts Healthy Volunteers No
Contacts
Contact: Flávia K Foronda, MD PhD +5511994440536 flikrepel@foronda.com.br
Contact: Leonardo R Fernandes, MD +5511951164242
Listed Location Countries Brazil
Removed Location Countries  
 
Administrative Information
NCT Number NCT04011852
Other Study ID Numbers 10055719.0.0000.0068
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party University of Sao Paulo General Hospital
Study Sponsor University of Sao Paulo General Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Flávia K Foronda, MDPhD Full staff
PRS Account University of Sao Paulo General Hospital
Verification Date July 2019

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