Child Clinical Trial
Official title:
The Role of Chest Electrical Impedance Tomography in the Pediatric Ventilator Weaning
Verified date | November 2023 |
Source | University of Sao Paulo General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 83 |
Est. completion date | November 30, 2023 |
Est. primary completion date | November 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 28 Days to 15 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Brazil | University of São Paulo General Hospital | São Paulo | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo General Hospital |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correlate Electrical impedance tomography to Extubation failure | Compare data obtained by the EIT during the spontaneous breathing trial with Extubation failure | 48 hours | |
Primary | 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 | Electrical impedance tomography Security | Evaluate Electrical impedance tomography Security (skin lesion or pain)
Neonatal Skin Condition Score Dryness Normal, no sign of dry skin Dry skin, visible scaling Very dry skin, cracking/fissures Erythema No evidence of erythema Visible erythema, < 50% body surface Visible erythema, = 50% body surface Breakdown None evident Small, localized areas Extensive Note: Perfect score = 3 Worst score = 9 |
2 hours | |
Secondary | 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. | 1 hour |
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