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Идёт набор NCT07256821

Identifying the Optimal IMT Dose in ICU

— Наблюдательное Difficult to Wean, Mechanically Ventilated Patients With a Tracheostomy

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: Inspiratory Muscle Training.
Кому может быть актуально
Состояния в реестре: Difficult to Wean, Mechanically Ventilated Patients With a Tracheostomy. 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
Великобритания
Следующий шаг
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Официальное название

A Prospective, Mixed Methods, Observational Study to Define a Diaphragm-focussed and Patient-acceptable Inspiratory Muscle Training (IMT) Load in Difficult to Wean, Mechanically Ventilated Patients

Обзор

200,000 adults are admitted to intensive care in the UK each year. Many of these patients need help with their breathing and are put on a machine called a ventilator. Research shows that many patients using a ventilator quickly develop weakness in their main breathing muscle, called the diaphragm. This weakness can cause a longer time on the ventilator, a longer hospital stay, and higher chances of health problems or death. Inspiratory muscle training is a breathing exercise where the patient breathes against resistance through a small device (like breathing through a straw). It aims to improve the strength of the diaphragm and reduce how long patients are on the ventilator. Why is this research needed? Research shows that current breathing exercise programmes do not help patients come off the ventilator or go home quicker. This may be because these breathing exercises strengthen the wrong muscles (those in the chest and neck, that are not efficient). These exercises can also be distressing for patients. What will be done in this research? This research aims to develop a breathing exercise programme that focusses on strengthening the diaphragm. We will also make sure patients do not find the breathing exercise too distressing. This research will measure how the breathing muscles respond to four different levels of breathing exercise and ask patients to feedback on each level. 1. At each breathing exercise level, the effort of the breathing muscles will be measured using a small tube inserted into the nostril and small sticky patches on the chest and neck. We aim to find the level where the diaphragm is being pushed to work hard but other muscles in the chest and neck are not. 2. After each breathing exercise level patients will be asked how they found it - for example, easy, pleasant, scary. This procedure will be repeated 1-3 times over seven days with at least 24 hours between each measurement

Вмешательства

  • Другое Inspiratory Muscle Training
    Inspiratory muscle training at no load, and at 15, 25, 35 and 45% participants maximal inspiratory pressure

Первичные конечные точки

  • Diaphragmatic muscle activation (measured by electromyography) [Срок оценки: Up to 7 days]
  • Extra diaphragmatic muscle activity (surface electromyography of scalene, sternocleidomastoid and parasternal muscles) [Срок оценки: Up to 7 days]
  • Perceived difficultly and unpleasantness (number rating scale 0-10) [Срок оценки: Up to 7 days]
  • The experience of IMT using qualitative techniques including verbal and non-verbal (including written communication, picture and word boards) [Срок оценки: Up to 7 days]

Критерии участия

Критерии включения

  • Mechanically ventilated patients with a tracheostomy
  • Aged ≥ 18 years
  • Co-operative and able to participate in IMT.
  • Informed consent or surrogate approval

Критерии исключения

  • Facial or skull fracture, or a bleeding disorder which would prohibit oesophageal catheter placement.
  • Undrained pneumothorax/pneumomediastinum.
  • Delirium or deep sedation that impedes the patient's ability to participate in study procedures
  • Pregnancy
  • Unlikely to survive, or consultant assessment that the patient is not appropriate.
  • Wounds that prohibit EMG electrode placement.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Великобритания · 1 центр
  • Royal Brompton and Harefield Hospitals — Marlow

Публикации

  • Jenkins TO, Polkey MI, McWilliams D, Kilbride C, MacBean V. Defining a diaphragm-focused and patient-acceptable inspiratory muscle training (IMT) load in difficult to wean, mechanically ventilated patients: a protocol for a prospective, mixed methods study. BMJ Open Respir Res. 2026 Jun 24;13(1):e004168. doi: 10.1136/bmjresp-2026-004168. PMID 42342294

Идентификаторы

NCT: NCT07256821 · 25/WA/0242

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗