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Идёт набор NCT07161271

Retrospective Cohort Study of Low-Flow Extracorporeal Carbon Dioxide Removal (ECCO2R) System: Evaluating ECCO2R's Efficacy and Safety in Participants With Respiratory Failure

— Наблюдательное Respiratory Failure ICU Asthma (Diagnosis) ARDS

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Respiratory Failure, ICU, Asthma (Diagnosis), ARDS. 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
Гонконг
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Retrospective Cohort Study of Low-Flow Extracorporeal Carbon Dioxide Removal (ECCO2R) System: Evaluating Efficacy and Safety

Обзор

This is an observational study performed by retrospective review of data routinely collected for patients receiving low-flow extracorporeal carbon dioxide removal (ECCO2R) therapy in intensive care units (ICUs). Our aim is to firstly, describe the local practice in terms of patient selection and technical details of clinical management related to the use of low-flow ECCO2R system, and secondly, the clinical results in terms of patient outcomes and adverse events. These findings may allow clinicians to improve the quality and safety of ECCO2R therapy provision in the ICU.

Подробное описание

Extracorporeal carbon dioxide removal (ECCO2R) is a specialised medical procedure employed to eliminate excessive carbon dioxide (CO2) from the bloodstream. To date, there have been only a few small-scale studies published on ECCO2R, with limited data on the full spectrum of clinical presentations, management strategies, and outcomes. Previous clinical trials have investigated the potential for ECCO2R therapy to reduce the intensity of mechanical ventilation in patients suffering from acute respiratory distress syndrome (ARDS). While these trials have successfully achieved desired physiological outcomes, they have not consistently translated into improved patient mortality rates. Additionally, the use of ECCO2R has presented certain complications, especially when higher-flow ECCO2R systems based on the centrifugal pump technology were used, which had been more extensively studied in the past. However, our clinical experience appeared to suggest that low-flow ECCO2R therapy could be managed with reasonable treatment success rate and limited complications. The investigators hypothesise that the use of low-flow ECCO2R therapy is clinically effective and safe for a selected group of ICU patients with acute respiratory failure.

Первичные конечные точки

  • Around 60 participants with respiratory failure as assessed for their clinical characteristics and outcomes [Срок оценки: From November 2024 to September 2026 (Anticipated)]

Критерии участия

Критерии включения

  • Patients supported with ECCO2R in one of the designated study sites
  • Admitted to the ICU between 1 Jan 2022 and 30 June 2024

Критерии исключения

  • Patients younger than 18 years old

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Гонконг · 1 центр
  • Queen Mary Hospital (QMH) — Гонконг

Публикации

  • McNamee JJ, Gillies MA, Barrett NA, Perkins GD, Tunnicliffe W, Young D, Bentley A, Harrison DA, Brodie D, Boyle AJ, Millar JE, Szakmany T, Bannard-Smith J, Tully RP, Agus A, McDowell C, Jackson C, McAuley DF; REST Investigators. Effect of Lower Tidal Volume Ventilation Facilitated by Extracorporeal Carbon Dioxide Removal vs Standard Care Ventilation on 90-Day Mortality in Patients With Acute Hypox PMID 34463700
  • Brodie D, Slutsky AS, Combes A. Extracorporeal Life Support for Adults With Respiratory Failure and Related Indications: A Review. JAMA. 2019 Aug 13;322(6):557-568. doi: 10.1001/jama.2019.9302. PMID 31408142
  • Barbic B, Bianchi C, Madotto F, Sklar MC, Karagiannidis C, Fan E, Brochard L. The Failure of Extracorporeal Carbon Dioxide Removal May Be a Failure of Technology. Am J Respir Crit Care Med. 2024 Apr 1;209(7):884-887. doi: 10.1164/rccm.202309-1628LE. No abstract available. PMID 38190699
  • Giraud R, Banfi C, Assouline B, De Charriere A, Cecconi M, Bendjelid K. The use of extracorporeal CO2 removal in acute respiratory failure. Ann Intensive Care. 2021 Mar 11;11(1):43. doi: 10.1186/s13613-021-00824-6. PMID 33709318
  • Zhou Z, Li Z, Liu C, Wang F, Zhang L, Fu P. Extracorporeal carbon dioxide removal for patients with acute respiratory failure: a systematic review and meta-analysis. Ann Med. 2023 Dec;55(1):746-759. doi: 10.1080/07853890.2023.2172606. PMID 36856550
  • Morelli A, Del Sorbo L, Pesenti A, Ranieri VM, Fan E. Extracorporeal carbon dioxide removal (ECCO2R) in patients with acute respiratory failure. Intensive Care Med. 2017 Apr;43(4):519-530. doi: 10.1007/s00134-016-4673-0. Epub 2017 Jan 28. PMID 28132075

Идентификаторы

NCT: NCT07161271 · UW 24-480 · HKU/HA HKW IRB

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗