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Идёт набор NCT05906472

PUSH-IT Continuing Enteral Feeds for Tracheostomy

Без фазы С лечением Tracheostomy Complication Critical Illness Nutritional Deficiency

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: Feeds continued, Feeds held.
Кому может быть актуально
Состояния в реестре: Tracheostomy Complication, Critical Illness, Nutritional Deficiency. 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
США
Следующий шаг
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Официальное название

Prevent Unnecessary Surgeon Holds of Ingestions for Tracheostomy (PUSH-IT)

Обзор

The goal of this clinical trial is to evaluate nutrition administration in the time around the tracheostomy in patients with breathing tubes. The main questions it aims to answer are: * Will continuing nutrition up to the time of surgery (tracheostomy) decrease nutrition interruptions, thereby increasing food intake? * Does continuing nutrition up to the time of surgery increase instances of food going into the lungs or lung infections? Researchers will compare patients who have nutrition withheld 6 hours prior to surgery versus those who receive nutrition up until the time of surgery to see if there are differences in food intake, instances of food entering the lungs or lung infections.

Подробное описание

Malnutrition is a significant problem in the critically ill, however with busy operating room schedules, we often find that feeds are interrupted repetitively prior to elective surgery. These interruptions are practiced based on the American Society of Anesthesiologist guidelines for fasting intervals for elective surgery. These guidelines, however, were not created for critically ill, intubated patients. The theoretical concern for an increased risk of aspiration with continuation of enteral feeds up to the time of surgery persists without supporting evidence. Thus, there is a need for a universal evidence-based guideline on perioperative enteral feeding to benefit critical care patients.

To this end, the goal of the present study is to implement a protocol designed to decrease the interruption of enteral feeds in critical care patients undergoing tracheostomy and prospectively evaluate whether this leads to a quantitative increase in nutritional intake without increasing the risk of aspiration. Additionally, we hope that increasing quantitative nutrition may decrease morbidity especially in the small subset of patients where feed interruptions occur repetitively.

If the aims of the project are achieved, the data obtained from this study will be used to create an evidence-based platform from which physicians can practice. This will end the anecdotal controversy regarding perioperative tube feed management for tracheostomy; thereby increasing quantitative nutrition and hopefully improving the care of critically ill patients.

Вмешательства

  • Другое Feeds continued
    Enteral feeds are continued up until time of surgery
  • Другое Feeds held
    Enteral feeds are stopped 6 or more hours before surgery

Первичные конечные точки

  • Rate of aspiration pneumonia [Срок оценки: Over 7 days from the time of tracheostomy]
Вторичные конечные точки (1)
  • Volume of tube feed delivery [Срок оценки: From day of consent to completion of study which is 7 days from the time of tracheostomy.]

Критерии участия

Критерии включения

  • 18 years or older
  • admitted to the intensive care unit (ICU)
  • intubated and require tracheostomy

Критерии исключения

  • under 18 years
  • unable to obtain informed consent
  • deemed clinically brain dead within 7 days of enrollment
  • transitioned to comfort measures within 7 days of enrollment
  • Pregnant patients
  • Prisoners

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

США · 6 центров
  • Nuvance Health - Danbury Hospital — Danbury
  • St. Mary's Medical Center — West Palm Beach
  • HCA Research Medical Center — Kansas City
  • Erie County Medical Center (University at Buffalo) — Buffalo
  • Lehigh Valley Health Network — Allentown
  • University of South Carolina Sch of Medicine /Prisma Health Richland — Columbia

Идентификаторы

NCT: NCT05906472 · STUDY 00005099

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗