Меню
Идёт набор NCT04367987

Variability of Heart Rate as a Marker of Complication of Colorectal Surgery

— Наблюдательное Surgery--Complications

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: Heart Rate Variability.
Кому может быть актуально
Состояния в реестре: Surgery--Complications. Базовые параметры: от 18 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
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

Heart rate variability reflects the autonomic nervous system on the intrinsic activity of sinus node cells. Sympathetic hyperactivity is an adaptation to stress, while parasympathetic hyperactivity is present at rest. Thus, any variability in the heart frequency rate reflects variations in sympathetic and parasympathetic components in the autonomic nervous system. Failure to return to normal or a reduction in the variability of the heart rate in the postoperative period is correlated with complications in colorectal surgery.

Вмешательства

  • Диагностический тест Heart Rate Variability
    Heart rate and RR interval Post-anonymized analysis of heart rate variability using the KUBIOS software

Первичные конечные точки

  • Rate of variability of the heart rate between Day-1 to Day 7 [Срок оценки: Day 7]
  • Correlation between the rate of variability of the heart rate between Day-1 to Day 7and anastomotic fistula diagnosed according to Center for Diseases Control criteria after scheduled colorectal surgery [Срок оценки: Hospital discharge (maximum Day 7)]
  • Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and peri-anastomotic fluid collections after scheduled colorectal surgery [Срок оценки: Hospital discharge (maximum Day 7)]
Вторичные конечные точки (12)
  • Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of intra abdominal abscess [Срок оценки: Hospital discharge (maximum Day 7)]
  • Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of gut wall abscess [Срок оценки: Hospital discharge (maximum Day 7)]
  • Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of pneumonia [Срок оценки: Hospital discharge (maximum Day 7)]
  • Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of urinary tract infection [Срок оценки: Hospital discharge (maximum Day 7)]
  • Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of central venous catheter infection [Срок оценки: Hospital discharge (maximum Day 7)]
  • Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of intra abdominal hematoma [Срок оценки: Hospital discharge (maximum Day 7)]
  • Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of hemorrhagic shock [Срок оценки: Hospital discharge (maximum Day 7)]
  • Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and death rate [Срок оценки: Hospital discharge (maximum Day 7)]
  • Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of deep vein thrombosis [Срок оценки: Hospital discharge (maximum Day 7)]
  • Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of pulmonary embolism [Срок оценки: Hospital discharge (maximum Day 7)]
  • Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of acute pulmonary edema [Срок оценки: Hospital discharge (maximum Day 7)]
  • Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of heart disease [Срок оценки: Hospital discharge (maximum Day 7)]

Критерии участия

Критерии включения

  • Patients operated for a scheduled colorectal resection due to cancer, diverticulitis, or Chronic Inflammatory Bowel Disease,
  • American Society of Anesthesiologists score 1-2
  • The patient must have given their free and informed consent and signed the consent form
  • The patient must be a member or beneficiary of a health insurance plan

Критерии исключения

  • Patient taking antidepressants, antipsychotics, antihypertensive beta blocker type, anti-arythmic or oral contraception
  • Uncontrolled diabetes or associated with a neuropathy
  • Arrhythmias and conduction disturbances, , coronaropathy and heart failure, kidney failure
  • Neuropathies
  • Pacemaker or defibrillator
  • The subject is participating in another interventional study, or is in a period of exclusion determined by a previous study
  • The subject refuses to sign the consent
  • It is impossible to give the subject informed information
  • The patient is under safeguard of justice or state guardianship

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • CHU de Nimes — Nîmes

Идентификаторы

NCT: NCT04367987 · Local/2018/MB-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗