Use of TrachPhone in Tracheostomized Patients

Официальное название

Safety, Feasibility, and Impact on Pulmonary Secretion Management Comparing the Use of TrachPhone and External Humidifier After Tracheostomy

Обзор

The use of Heat and Moisture Exchangers (HMEs) and their positive impact on pulmonary health have been extensively studied in patients with head and neck cancer but have not been systematically explored in other patient populations breathing through a neck stoma. The objective of this clinical investigation is to compare the use of HMEs to the use of External Humidifiers (EHs) on pulmonary secretion management, their usability and safety, for humidifying inhaled air in patients that received a tracheostomy due to a neurological condition.

Вмешательства

• Устройство TrachPhone HME
  Use of TrachPhone HME for humidification of inhaled air in tracheostomized patients. The TrachPhone HME is an HME specifically designed for tracheostomy patients.
• Устройство External Humidifier (Usual Care)
  Usual care routines using an External Humidifier for humidification of inhaled air in tracheostomized patients.

Первичные конечные точки

• Number of suctioning per day [Срок оценки: At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)]

Вторичные конечные точки (12)

• Time needed for suctioning [Срок оценки: At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)]
• Quality of secretion [Срок оценки: At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)]
• Quality of Life by EQ-5D-5L [Срок оценки: At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)]
• Use of TrachPhone [Срок оценки: At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)]
• Patient preference [Срок оценки: Upon discharge from the hospital (on average after 3 weeks)]
• Nurse and therapy team feedback [Срок оценки: Upon discharge of the last participant, on average after 1 year]
• Nursing time regarding device use [Срок оценки: At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)]
• Adherence to use of devices [Срок оценки: At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)]
• Patient communication [Срок оценки: At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)]
• Voice Quality [Срок оценки: At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)]
• Patient mobility [Срок оценки: Upon discharge of the last participant, on average after 1 year]
• Oxygen needs [Срок оценки: At Baseline, T1 follow-up, and TX follow-ups every 10-14 days until discharge]

Критерии участия

Критерии включения

• Tracheostomy patient outside critical care
• Self-ventilating via a tracheostomy tube, independent of cuff status
• 18 years or older

Критерии исключения

• Patients with tidal volume beyond recommended range (50-1000 ml)
• Dehydration
• Very heavy/excessive secretion from the lungs and airways (requiring more frequently tracheal suction, more than hourly suctioning)
• High oxygen need (FiO2 > 0.4)
• Acutely deteriorating patient

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

Другое

Центры проведения

Великобритания · 1 центр

• The Royal London Hospital, Barts Health NHS Trust — London

Идентификаторы

NCT: NCT06487104 · TrachPhone

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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