Clinical Trial: Transcranial Doppler Pulsatility Index as a Marker of Impaired Cerebral Compliance
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Transcranial Doppler Pulsatility Index Accuracy on the Indication of Impaired Cerebral Compliance
Brief Summary:
Introduction: Intracranial pressure (ICP) monitoring is essential in several neurological situations, however, this is an invasive technique, costly and could be contraindicated or unavailable. Transcranial Doppler (TCD) pulsatility index (PI) measure can provide indirect information on the cerebrovascular resistance (CVR) augmentation, which is present concomitantly with intracranial hypertension (ICH). The hypothesis that PI measure accurately indicates cerebral compliance impairment (CCI) has been not assessed by large studies currently, and would be of value as a non invasive technique to denote earlier installing of therapeutics to prevent the effects of ICH.
Objective: The present study aims to assess PI accuracy indicating CCI, and dynamic cerebral auto regulation (dCAR) during internal jugular veins (IJVs) compression.
Methods: A prospective, observational controlled study, including critical neurological patients with ICP monitoring in normal range (under 20 mmHg). Initially, dCAR is monitored, then, the IJVs are compressed for 60 seconds with ultrasound guidance. We evaluate optic nerve sheath prior to intervention, and dCAR, ICP values, ICP waveforms and PI variation at different times, correlating results.
Detailed Summary:
Introduction
Multimodal monitoring in neurocritical care is essential in current practice. It aims to early Identify treats occurring in the brain of comatose patients and implement targeted therapies to avoid further complications and poorer outcomes.
Some of the methods used for monitoring require invasive procedures, such as the assessment of intracranial pressure (ICP) with intracranial catheter. However, these techniques can raise morbidity, are costly, and are not available or contraindicated1. In addition, the invasive ICP method is not perfectly accurate with cases in which, intracranial hypertension (ICH) may be present despite normal screen ICP values2.
Transcranial Doppler (TCD) is a noninvasive bedside ultrasound technique which could be implemented in the monitoring of raised ICP3-4 and in the identification of impaired intracranial compliance by the compression of the internal jugular veins (IJVs)1. However, such application of the method has not been validate with large prospective studies. Validation of this technique would be of value for screening patients prior to suffer the consequences of ICH.
Objectives
1) Evaluate the reliability of TCD during the IJVs compression in the assessment of intracranial compliance; 2) evaluate dynamic cerebral auto regulation (dCAR) during IJVs compression.
Methods
This is a prospective observational study which will be performed at "Hospital das Clinicas" (São Paulo University School of Medicine). The sample desired is of 30 consecutive subjects, as a pilot study based in recommendations of the literature5. Afte
Sponsor: University of Sao Paulo
Current Primary Outcome: Impaired cerebral compliance [ Time Frame: 10 minutes ]
Original Primary Outcome: Elevation of TCD pulsatility index during jugular compression as the ICP values [ Time Frame: 10 minutes ]
Current Secondary Outcome: Impaired cerebral auto-regulation [ Time Frame: 10 minutes ]
Original Secondary Outcome: CBF velocities fluctuating as the AMP values [ Time Frame: 10 minutes ]
Information By: University of Sao Paulo
Dates:
Date Received: May 4, 2017
Date Started: May 1, 2017
Date Completion: July 31, 2018
Last Updated: May 5, 2017
Last Verified: May 2017
