Comparison of Physiological Effects of Two Types of High-Flow Oxygen Therapy in Tracheostomized Patients

Официальное название

Comparison of Physiological Effects of Standard and Modified High-Flow Oxygen Therapy in Tracheostomized Patients

Обзор

High-flow nasal oxygen therapy offers benefits like precise oxygen delivery, flow-related positive end-expiratory pressure generation and improved lung function. High-flow oxygen therapy can be applied via tracheostomy as high-flow tracheal oxygen. While high-flow tracheal oxygen has been used to facilitate weaning, it has diminished physiological effects due to bypassing upper airways. To enhance its effectiveness, researchers developed a modified high-flow tracheal oxygen tube with a smaller expiratory end diameter to increase airway resistance and pressure. This is a prospective randomized crossover study that aims to compare the physiological effects of standard and modified high-flow oxygen therapy in tracheostomized patients.

Подробное описание

High-flow nasal oxygen therapy has been shown to provide several physiological benefits, including precise control of the fraction of inspired oxygen, generation of flow-related positive end-expiratory pressure, increased end-expiratory lung volume, improved oxygenation, and enhanced carbon dioxide elimination. It has been widely utilized in managing acute hypoxemic respiratory failure and preventing hypoxemia after extubation.

High-flow oxygen therapy can be applied via tracheostomy as high-flow tracheal oxygen. Previous studies have reported successful cases of using high-flow tracheal oxygen to facilitate weaning from prolonged mechanical ventilation in patients with restrictive and obstructive pulmonary disorders. However, compared to high-flow nasal oxygen, high-flow tracheal oxygen exhibits significantly diminished physiological effects due to the bypassing of the narrow nasopharynx, glottis, and upper airway, as well as a more open circuit.

To address this limitation, the investigators have developed a modified high-flow tracheal oxygen tube with a reduced expiratory end tube diameter. This modification aims to create higher expiratory resistance and airway pressure, thus simulating the physiological effects of high-flow nasal cannula. This is a prospective randomized crossover physiological trial designed to compare the effects of standard and modified high-flow oxygen therapy in tracheostomized patients. Key physiological parameters will be assessed, including airway pressure, end-expiratory lung volume, vital signs, oxygenation, and respiratory workload.

Вмешательства

• Процедура Modified high flow tracheal oxygen
  Modified high-flow tracheal oxygen with flow rates of 40L/min and 60L/min will be performed.
• Процедура Standard high flow tracheal oxygen
  Standard high-flow tracheal oxygen with flow rates of 40 L/min and 60 L/min will be performed.

Первичные конечные точки

• Mean expiratory airway pressure [Срок оценки: From enrollment to the end of treatment at 4 hours]
• Positive end-expiratory pressure [Срок оценки: From enrollment to the end of treatment at 4 hours]
• Change of end-expiatory lung volume [Срок оценки: From enrollment to the end of treatment at 4 hours]

Вторичные конечные точки (8)

• Respiratory rate [Срок оценки: From enrollment to the end of treatment at 4 hours]
• Tidal volume [Срок оценки: From enrollment to the end of treatment at 4 hours]
• End-tidal carbon dioxide [Срок оценки: From enrollment to the end of treatment at 4 hours]
• Pulse oxygen saturation [Срок оценки: From enrollment to the end of treatment at 4 hours]
• Esophageal pressure-time product [Срок оценки: From enrollment to the end of treatment at 4 hours]
• Tidal swing of esophageal pressure [Срок оценки: From enrollment to the end of treatment at 4 hours]
• Respiratory muscle pressure [Срок оценки: From enrollment to the end of treatment at 4 hours]
• Dynamic transpulmonary pressure [Срок оценки: From enrollment to the end of treatment at 4 hours]

Критерии участия

Критерии включения

Tracheostomy with stable spontaneous breathing.

Критерии исключения

• Age younger than 18 years old
• Pregnancy
• Hemodynamic instability (mean arterial pressure <60 mmHg, heart rate >140 or <60 bpm)
• Respiratory and oxygenation instability (respiratory rate > 35bpm or oxygen saturation measured by pulse oximetry <90%)
• Neuromuscular diseases or phrenic nerve injury
• Recent trauma or surgery to the trachea, esophagus, neck, chest, or stomach
• Pneumothorax or placement of a chest drainage
• Contraindication to electrical impedance tomography (EIT) (implantable defibrillator)
• Anticipating withdrawal of life support

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing Shijitan Hospital — Пекин

Идентификаторы

NCT: NCT06816745 · IIT2024-158-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗