Critical Care, Oxygen Therapy, Tracheostomy
Conditions
Keywords
high-flow tracheal oxygen, tracheostomy
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREModified high flow tracheal oxygen
Modified high-flow tracheal oxygen with flow rates of 40L/min and 60L/min will be performed.
PROCEDUREStandard high flow tracheal oxygen
Standard high-flow tracheal oxygen with flow rates of 40 L/min and 60 L/min will be performed.
Sponsors
Jian-Xin Zhou
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Tracheostomy with stable spontaneous breathing.
Exclusion criteria
1. Age younger than 18 years old 2. Pregnancy 3. Hemodynamic instability (mean arterial pressure \<60 mmHg, heart rate \>140 or \<60 bpm) 4. Respiratory and oxygenation instability (respiratory rate \> 35bpm or oxygen saturation measured by pulse oximetry \<90%) 5. Neuromuscular diseases or phrenic nerve injury 6. Recent trauma or surgery to the trachea, esophagus, neck, chest, or stomach 7. Pneumothorax or placement of a chest drainage 8. Contraindication to electrical impedance tomography (EIT) (implantable defibrillator) 9. Anticipating withdrawal of life support
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean expiratory airway pressure | From enrollment to the end of treatment at 4 hours | Mean expiratory airway pressure will be measured during standard and modified high-flow tracheal oxygen. |
| Positive end-expiratory pressure | From enrollment to the end of treatment at 4 hours | Positive end-expiratory pressure will be measured during standard and modified high-flow tracheal oxygen. |
| Change of end-expiatory lung volume | From enrollment to the end of treatment at 4 hours | Change of end-expiatory lung volume will be measured during standard and modified high-flow tracheal oxygen. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pulse oxygen saturation | From enrollment to the end of treatment at 4 hours | Pulse oxygen saturation will be measured during standard and modified high-flow tracheal oxygen. |
| Esophageal pressure-time product | From enrollment to the end of treatment at 4 hours | Esophageal pressure-time product will be measured during standard and modified high-flow tracheal oxygen. |
| Respiratory rate | From enrollment to the end of treatment at 4 hours | Respiratory rate will be measured during standard and modified high-flow tracheal oxygen. |
| Respiratory muscle pressure | From enrollment to the end of treatment at 4 hours | Respiratory muscle pressure will be measured during standard and modified high-flow tracheal oxygen. |
| Dynamic transpulmonary pressure | From enrollment to the end of treatment at 4 hours | Dynamic transpulmonary pressure will be measured during standard and modified high-flow tracheal oxygen. |
| Tidal swing of esophageal pressure | From enrollment to the end of treatment at 4 hours | Tidal swing of esophageal pressure will be measured during standard and modified high-flow tracheal oxygen. |
| Tidal volume | From enrollment to the end of treatment at 4 hours | Tidal volume will be measured during standard and modified high-flow tracheal oxygen. |
| End-tidal carbon dioxide | From enrollment to the end of treatment at 4 hours | End-tidal carbon dioxide will be measured during standard and modified high-flow tracheal oxygen. |
Countries
China
Contacts
Primary ContactJian-Xin Zhou, MD, PhD
Backup ContactShan-Shan Xu, MD
Outcome results
None listed