Non Invasive Measurement With Trans Cranial Doppler Versus Invasive Measurement in Pediatric Age

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 18
SponsorAzienda Ospedaliera di Padova

About this trial

An increase of intracranial pressure (ICP) is an important cause of secondary brain damage. The gold standard for measuring ICP is represented by invasive positioning of intracranial ICP devices.

The most used non-invasive methods (nICP) are obtained through bed-side ultrasound, routinely used in the management of children in Pediatric Intensive Care: arterial Trancranial Doppler (TCD) and ultrasound measurement of the diameter of the optic nerve sheath (ONSD ).

In this study it is proposed to compare the measurement of nICP obtained by TCD and ONSD versus the measurement obtained by the invasive monitoring (iICP) already present.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

invasive ICP placement

Disqualifiers

cranial base fracture

absent informed consent

Trial population

pediatric patients with planned invasive ICP admitted to PICU

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • bedside sonography

    Device

    TCD and ONSD sonography twice a day per 2 days

Treatment groups

46 Participants
are divided into 1 treatment group
Group A: pediatric patients with ICP device1 intervention

Trial outcomes

Primary outcomes

1

comparison between ICP and nICP (measured by TCD)

For each patient with invasive ICP, the nICP (measured by TCD) will be compared. We will collect ICP and nICP in pairs for each measurement ( T1 ) using the same unit of measurement. (During 48 hours we will collect ICP and nICP in pairs 4 times: T1 T2 T3 T4. We will finally evaluate the data in pairs in the total sample).

Time frame
within 48 hours after the invasive ICP placement
2

comparison between ICP and nICP (measured by TCD)

For each patient with invasive ICP, the nICP (measured by TCD) will be compared. We will collect ICP and nICP in pairs for each measurement ( T2 ) using the same unit of measurement. (During 48 hours we will collect ICP and nICP in pairs 4 times: T1 T2 T3 T4. We will finally evaluate the data in pairs in the total sample).

Time frame
within 48 hours after the invasive ICP placement
3

comparison between ICP and nICP (measured by TCD)

For each patient with invasive ICP, the nICP (measured by TCD) will be compared. We will collect ICP and nICP in pairs for each measurement ( T3 ) using the same unit of measurement. (During 48 hours we will collect ICP and nICP in pairs 4 times: T1 T2 T3 T4. We will finally evaluate the data in pairs in the total sample).

Time frame
within 48 hours after the invasive ICP placement
4

comparison between ICP and nICP (measured by TCD)

For each patient with invasive ICP, the nICP (measured by TCD) will be compared. We will collect ICP and nICP in pairs for each measurement ( T4 ) using the same unit of measurement. (During 48 hours we will collect ICP and nICP in pairs 4 times: T1 T2 T3 T4. We will finally evaluate the data in pairs in the total sample).

Time frame
within 48 hours after the invasive ICP placement

Secondary outcomes

1

comparison between ICP and nICP (measured by ONSD)

For each patient with invasive ICP, the nICP (measured by ONSD) will be compared twice a day for 2 days. We will collect ICP and nICP in pairs for each measurement (4 times: T1 T2 T3 T4) using the same unit of measurement and evaluate the data in pairs in the total sample.

Time frame
within 48 hours after the invasive ICP placement
2

interrater reliability for TCD measurement

For each patient with invasive ICP, two nICP measurement by TCD will be performed by two operators blinded each other. We will collect nICP values in pairs (by two operators) for each measurement (2 times) using the same unit of measurement and evaluate the data in pairs in the total sample.

Time frame
within 48 hours after the invasive ICP placement
3

interrater reliability for ONSD measurement

For each patient with invasive ICP, two nICP measurement by ONSD will be performed by two operators blinded each other. We will collect nICP values in pairs (by two operators) for each measurement (2 times) using the same unit of measurement and evaluate the data in pairs in the total sample.

Time frame
within 48 hours after the invasive ICP placement

Other outcomes

Sponsors and contacts

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