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

NCT04011852 | Completed

• 1 other identifier: 10055719.0.0000.0068
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilator Weaning; Child; Spontaneous Breathing Trial; Electrical Impedance Tomography

Keywords

Ventilator Weaning; Child; Electrical Impedance Tomography; Respiration, artificial; Intensive Care units

Outcome Measures

Primary Outcomes (2)

• Correlate Electrical impedance tomography to Extubation failure

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

  48 hours

• 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

  1 hour

Secondary Outcomes (2)

• Electrical impedance tomography Security

  2 hours

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

  1 hour

Interventions

Electrical Impedance tomography DEVICE

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

Eligibility Criteria

• Age: 28 Days - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

University of São Paulo General Hospital

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Flávia K Foronda, MDPhD

  Full staff

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2019
• First Posted: July 9, 2019
• Study Start: September 26, 2019
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: December 8, 2023

Record last verified: 2023-11

Locations

BR (1)