Идёт набор NCT02368041

Utility of Thenar Near Infrared Spectroscopy (NIRS) in Pediatric Patients With Heart Failure

— Наблюдательное Heart Failure

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: InSpectraTM StO2 monitor.
Кому может быть актуально: Состояния в реестре: Heart Failure. Базовые параметры: до 25 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

This is a single-center, non-randomized study.The study staff will use the InSpectraTM tissue oxygen saturation (StO2) monitor manufactured by Hutchinson Technology to measure baseline StO2 levels after applying the noninvasive probe to the thenar eminence. After a stable reading is obtained, a blood pressure cuff will be inflated 40 mmHg above the obtained systolic pressure and the rate of desaturation (Rdes; % × sec-1) will be recorded. After 3 minutes or once the StO2 level comes to zero (whichever is earlier), the cuff pressure will be released and the rate of reperfusion (Rres; % × sec-1) will be measured. The investigators hypothesize that heart failure in children causes a baseline lower thenar tissue oxygen saturation (StO2), a faster rate of desaturation (Rdes) and a prolonged rate of reperfusion (Rres). The investigators also hypothesize that these changes will correlate with the severity of heart failure. The results of this study will provide groundwork for studies looking at correlation of therapy modification based on the combination thenar StO2 and clinical presentation.

Подробное описание

Heart failure patients seen in the Pediatric Cardiology Congenital Heart Center will be enrolled into the study after obtaining informed consent on the day of their evaluation. The primary pediatric cardiologist following the patient will evaluate the need for regular investigations like blood work, electrocardiogram and echocardiogram. The study staff will use the InSpectraTM tissue oxygen saturation (StO2) monitor manufactured by Hutchinson Technology to measure the baseline StO2 level after applying the noninvasive probe to the thenar eminence. After a stable reading is obtained a blood pressure cuff will be inflated 40 mmHg above the obtained systolic pressure and the rate of desaturation (Rdes; % × sec-1) will be recorded. After 3 minutes or once the StO2 level comes to zero (whichever is earlier), the cuff pressure will be released and the rate of reperfusion (Rres; % × sec-1) will be measured. Similar measurements will be obtained from an otherwise healthy cohort of children who present to the Pediatric Cardiology Congenital Heart Center for evaluation of a heart murmur or chest pain. The patient's treating physician and care providers will be blinded to the study test results. All clinical care will be at the discretion of the patient's treating physicians. Only StO2 levels will be obtained using the non-invasive probe placed on the thenar eminence for the purpose of the study.

Вмешательства

Устройство InSpectraTM StO2 monitor
InSpectraTM StO2 monitor manufactured by Hutchinson Technology Inc. to measure the baseline StO2 level after applying the noninvasive probe to the thenar eminence. After a stable reading is obtained a blood pressure cuff will be inflated 40 mmHg above the obtained systolic pressure and the rate of desaturation (Rdes; % × sec-1) will be recorded. After 3 minutes or once the StO2 level comes to zero, whichever is earlier the cuff pressure will be released instantaneously and the rate of reperfusio

Первичные конечные точки

Baseline StO2 percentage [Срок оценки: Day 1]

Вторичные конечные точки (2)

Occlusion- rate of desaturation (Rdes) of StO2 levels [Срок оценки: Day 1]
Recovery- rate of reperfusion (Rres) of StO2 levels [Срок оценки: Day 1]

Критерии участия

Критерии включения

Heart failure patients under 25 years of age with a diagnosis of cardiomyopathy, myocarditis or univentricular palliation for congenital heart disease who are stable on their medical management will be enrolled.