CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 66 enrolled
Drug / intervention
Near-infrared spectroscopy-based assessement of cerebral autoregulation.other
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03949738
NCT03949738N/ACompleted

Cerebrovascular Hemodynamics and Neurocognitive Outcome in Patients With Acute Respiratory Distress Syndrome.

Universitätsklinikum Hamburg-Eppendorf·observational·Posted May 14, 2019·Updated Oct 26, 2021

In Brief

An observational study evaluating Near-infrared spectroscopy-based assessement of cerebral autoregulation. for ARDS. Completed, enrolled 66 participants across 1 site.

Detailed Summary

The acute respiratory distress syndrome (ARDS) is a life-threatening disease with functional impairment of the lung. It is characterized by an excessive inflammatory response of lung tissue, capillaries, and blood vessels and is associated with high mortality. Patients who survive the acute phase of this critical disease often suffer from long-term physical, psychological, and mental sequelae, as well as persistent cognitive deficits. In healthy individuals, autoregulatory mechanisms of the intracranial blood vessels keep blood supply to the brain independent of fluctuations in systemic blood pressure. In the case of a serious illness, these mechanisms of autoregulation may be impaired, which may favor cerebral hypoperfusion. Impairment of cerebrovascular hemodynamics can lead to neuronal damage in short and long term. The aim of this project is to investigate cerebrovascular autoregulation in adult patients with ARDS and to evaluate the cognitive outcome at 3, 6 and 12 months after discharge from the intensive care unit.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsARDS
CountriesGermany
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedMay 14, 2019
Enrollment StartDec 1, 2018
Primary CompletionNov 30, 2019
Study CompletionNov 30, 2020
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 7.1 years ago

Interventions

Near-infrared spectroscopy-based assessement of cerebral autoregulation.other

Cerebral autoregulation is assessed using a software that calculates correlation coefficients based on the values of cerebral oxygenation (detected by near-infrared spectroscopy) and invasively measured arterial blood pressure. Correlation coefficients are calculated at 10-second intervals and averaged over a period of 300 seconds, resulting in an autoregulation index (cerebral oxygenation index, COx). The index can range between -1 and +1. It provides information about cerebral autoregulation capacity, with a value below 0.3 indicating intact cerebral autoregulation.