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Идёт набор NCT06247397

Effect of HIgh-flow Therapy in Long-term Oxygen Therapy

Без фазы С лечением Chronic Obstructive Pulmonary Disease Severe Interstitial Lung Disease Chronic Respiratory Failure With Hypoxia

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: Added high-flow oxygen therapy, Standard care.
Кому может быть актуально
Состояния в реестре: Chronic Obstructive Pulmonary Disease Severe, Interstitial Lung Disease, Chronic Respiratory Failure With Hypoxia. 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
Швеция
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

Effect of HIgh-flow Therapy in Long-term Oxygen Therapy (HILOT): A Multicenter, Registry-based, Randomized Clinical Trial

Обзор

This is a registry-based, randomized, controlled clinical trial of the effect of added high-flow oxygen therapy (using the device Lumis HFT) during one year in people with long-term oxygen therapy (LTOT) for chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD).

Подробное описание

This is a registry-based, randomized, controlled clinical trial of patients with LTOT for COPD or ILD recruited using the Swedish National Registry for Respiratory Failure (Swedevox) in collaboration with a research network within the Swedish Respiratory Society. The trial evaluates the effect of added high-flow oxygen therapy nighttime to the regular low-flow oxygen therapy compared with regular low-flow oxygen therapy alone up to one year.

The purpose of this project is to improve evidence-based treatment of people with chronic respiratory failure, currently about 2000 patients annually in Sweden, who have high risk of adverse events and mortality.

Вмешательства

  • Устройство Added high-flow oxygen therapy
    Added high-flow oxygen therapy using the device Lumis HFT during nighttime and at the patient's discretion daytime, with the usual care (low-flow oxygen therapy) the rest of the time.
  • Другое Standard care
    Standard care with low-flow oxygen therapy in accordance with clinical routine.

Первичные конечные точки

  • Time to first hospitalization or death from all causes [Срок оценки: 1 year]
Вторичные конечные точки (12)
  • Time to first all-cause hospitalization or all-cause death [Срок оценки: 1 year]
  • Rate of hospitalizations or death from all causes [Срок оценки: 1 year]
  • Hospitalization rate from all causes [Срок оценки: 1 year]
  • Hospitalization rate from respiratory disease [Срок оценки: 1 year]
  • Number of hospitalized days [Срок оценки: 1 year]
  • Hospitalization rate from cardiovascular disease [Срок оценки: 1 year]
  • Number of admissions to intensive care unit (ICU) [Срок оценки: 1 year]
  • Number of days in ICU [Срок оценки: 1 year]
  • Mortality rate from all causes [Срок оценки: 1 year]
  • Mortality rate from respiratory disease [Срок оценки: 1 year]
  • Mortality rate from cardiovascular disease [Срок оценки: 1 year]
  • Time to first exacerbation [Срок оценки: 1 year]

Критерии участия

Критерии включения

  • Age 40 years or older
  • Ongoing LTOT: prescribed for at least 15 hours per day; and since at least 28 days as registered in Swedevox
  • COPD or ILD as main underlying reason for LTOT
  • Oxygen concentrator as stationary oxygen source in the home including night-time
  • Body mass index (BMI) < 35 kg/m2

Критерии исключения

  • Current or previous treatment with home HFOT
  • Current treatment with home mechanical ventilation
  • Current treatment with home CPAP
  • Hospitalized during the last 2 weeks
  • Current smoking or contact with flames
  • Self-reported average use of the LTOT < 15h per day (24 hours)
  • PaCO2 (breathing air at rest) > 8 kPa
  • Strong clinical suspicion of obstructive sleep apnea (OSA) or obesity-related hypoventilation syndrome (OHS) (as judged by the responsible staff)
  • Inability to participate in the study procedures (as judged by the staff)
  • Not eligible for continuing LTOT due to other reason (as judged by the staff)
  • Expected survival less than 3 months (as judged by the staff)

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
Лечение

Центры проведения

Швеция · 2 центра
  • Research Unit, Blekinge University of Technology — Karlskrona
  • Department of Heart, Lung and Clinical Physiology, Örebro University Hospital — Örebro

Публикации

  • Sundh J, Ljunggren M, Palm A, Lindberg E, Lavergne F, Weinreich UM, Ahmadi Z, Ekstrom M; HILOT Collaboration Group. Effect of HIgh-Flow Therapy in Long-Term Oxygen Therapy (HILOT): study protocol for a multicentre, registry-based, randomised clinical trial. Trials. 2026 Feb 4;27(1):177. doi: 10.1186/s13063-026-09488-8. PMID 41634827

Идентификаторы

NCT: NCT06247397 · HILOT

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗