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Идёт набор NCT07130123

Endotracheal Suctionning During Positive Pressure Extubation in ICU

Без фазы С лечением Mechanical Ventilation With Oral Intubation Weaning Invasive Mechanical Ventilation Oxygen Saturation Measurement Rox Index

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: Suctionning extubation, No suctionning Extubation.
Кому может быть актуально
Состояния в реестре: Mechanical Ventilation With Oral Intubation, Weaning Invasive Mechanical Ventilation, Oxygen Saturation Measurement, Rox Index. 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
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Официальное название

Removal of the Intubation Tube Under Positive Pressure With or Without Endotracheal Suctioning During Extubation in Intensive Care: a Prospective Randomised Controlled Trial

Обзор

The aim of this clinical trial is to evaluate endotracheal suctioning during positive pressure extubation in mechanically ventilated adult patients (over 18 years old) in the intensive care unit (ICU). The main question it aims to answer is whether the intervention improves the respiratory oxygenation index (ROX) three hours after extubation compared to no endotracheal suction during positive pressure extubation. Participants will only need to be extubated by the nursing team in the ICU. Follow-up will consist of evaluating respiratory rate, pulse oximetry and inspired oxygen fraction for three hours following extubation.

Подробное описание

This is a prospective, randomised, controlled trial. The aim of this study is to evaluate endotracheal suctioning during positive pressure extubation in mechanically ventilated adult patients (over 18 years old) in the intensive care unit (ICU). The main question it aims to answer is whether the intervention improves the respiratory oxygenation index (ROX) three hours after extubation compared to no endotracheal suction during positive pressure extubation.

Inclusion : Participants who meet eligibility criteria will be randomized into experimental arm (endotracheal suctioning during positive pressure extubation) or control arm (no endotracheal suction during positive pressure extubation).

Intervention and Follow-up : participants will only need to be extubated by the nursing team in the ICU. Follow-up will consist of evaluating respiratory rate, pulse oximetry and inspired oxygen fraction for three hours following extubation.

End of study : at the end of the study visit (28 days after extubation), vital status of participants will be recorded.

Вмешательства

  • Процедура Suctionning extubation
    We will remove the intubation tube with endotracheal suctioning during the extubation procedure and maintain positive end expiratory pressure (PEEP) and pressure support. The PEEP level will be 10 cmH2O and the pressure support 7 cmH2O for 2 minutes prior to extubation. The vacuum level will be the maximum level (standard procedure in the unit), i.e. 450 mmHg. The closed-system suction probe is inserted up to the last mark corresponding to 40cm. The size of our closed system is identical for all
  • Процедура No suctionning Extubation
    In the control group, removal of the intubation tube during the extubation procedure is performed with PEEP maintained, without endotracheal suctioning. The PEEP level will be set at 10 cmH2O and the pressure at 7 cmH2O in the 2 minutes prior to extubation.

Первичные конечные точки

  • Respiratoy/oxygenation index (ROX index) [Срок оценки: 3 hours after extubation]
Вторичные конечные точки (4)
  • Mechanical ventilation weaning failure [Срок оценки: During 7 days after extubation]
  • ROX index evolution [Срок оценки: During 3 hours after extubation]
  • Pneumonia after extubation [Срок оценки: During 7 days after extubation]
  • Airway clearance technique [Срок оценки: During 24 hours after extubation]

Критерии участия

Критерии включения

  • Adult patient
  • Intubated for more than 48 hours
  • Patient for whom extubation is prescribed by the patient's physician

Критерии исключения

  • Headboard restriction>30°.
  • Decision to limit active treatment in advance of reintubation
  • Protected person (under guardianship or curatorship)
  • Person under court protection
  • Persons deprived of liberty
  • Persons not affiliated to a social security scheme
  • Pregnant or breast-feeding woman
  • No co-inclusion with a study whose period of interest is follow-up within 3 hours of extubation.

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
Простое слепое
Основная цель
Лечение

Центры проведения

Франция · 1 центр
  • Centre Hospitalier Universitaire d'Orléans — Orléans

Публикации

  • Chastre J, Fagon JY. Ventilator-associated pneumonia. Am J Respir Crit Care Med. 2002 Apr 1;165(7):867-903. doi: 10.1164/ajrccm.165.7.2105078. PMID 11934711
  • Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, Zhu J, Sachdeva R, Sonnad S, Kaiser LR, Rubinstein NA, Powers SK, Shrager JB. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008 Mar 27;358(13):1327-35. doi: 10.1056/NEJMoa070447. PMID 18367735
  • Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, Pearl R, Silverman H, Stanchina M, Vieillard-Baron A, Welte T. Weaning from mechanical ventilation. Eur Respir J. 2007 May;29(5):1033-56. doi: 10.1183/09031936.00010206. PMID 17470624
  • Frutos-Vivar F, Esteban A, Apezteguia C, Gonzalez M, Arabi Y, Restrepo MI, Gordo F, Santos C, Alhashemi JA, Perez F, Penuelas O, Anzueto A. Outcome of reintubated patients after scheduled extubation. J Crit Care. 2011 Oct;26(5):502-509. doi: 10.1016/j.jcrc.2010.12.015. Epub 2011 Mar 3. PMID 21376523
  • Fossat G, Desmalles E, Courtes L, Fossat C, Boulain T. Cough Peak Flow Assessment Without Disconnection From the ICU Ventilator in Mechanically Ventilated Patients. Respir Care. 2023 Apr;68(4):470-477. doi: 10.4187/respcare.10412. Epub 2023 Mar 6. PMID 36878644

Идентификаторы

NCT: NCT07130123 · CHUO-2025-12

Первоисточники (государственные реестры)

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