Critical Care, Mechanical Ventilation, Oxygen Therapy
Conditions
Keywords
high-flow tracheal oxygen, T piece, spontaneous breathing trial
Brief summary
Spontaneous breathing trials (SBT) are essential for assessing extubation tolerance, yet optimal approaches are debated. High-flow nasal oxygen offers benefits like precise oxygen delivery, flow-related positive end-expiratory pressure generation and improved lung function. While high-flow tracheal oxygen can also be used as an SBT method, it has reduced physiological effects due to bypassing the upper airway with a more open circuit. To enhance this limitation, investigators developed a modified high-flow tracheal oxygen tube with a smaller expiratory end diameter to increase expiratory resistance and airway pressure. This is a prospective randomized crossover study that aims to compare the physiological effects of standard and modified high-flow tracheal oxygen versus T-piece during SBT.
Detailed description
A spontaneous breathing trial (SBT) is a crucial step in the weaning and extubation process for assessing extubation tolerance. However, the optimal approach for conducting SBTs remains a topic of debate. High-flow nasal oxygen 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. High-flow oxygen therapy can also be applied via an artificial airway as high-flow tracheal oxygen. Previous studies have identified this therapy as a potential alternative for SBTs. 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, thereby simulating the physiological effects of HFNC. This study is a prospective randomized crossover physiological study designed to compare the effects of standard and modified high-flow tracheal oxygen versus T-piece during spontaneous breathing trials. 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-40L/min
Modified high-flow tracheal oxygen with a flow rate of 40L/min will be performed.
PROCEDUREStandard high flow tracheal oxygen-40L/min
Standard high-flow tracheal oxygen with a flow rate of 40 L/min will be performed.
PROCEDURET-piece
T-piece will be performed.
PROCEDUREModified high-flow tracheal oxygen-60L/min
Modified high-flow tracheal oxygen with a flow rate of 60L/min will be performed.
PROCEDUREStandard high-flow tracheal oxygen-60 L/min
Standard high-flow tracheal oxygen with a flow rate of 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
1. Mechanical ventilation for more than 24 hours 2. Considered by the physicians for the readiness to wean and ready for spontaneous breathing trials
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 versus T-piece. |
| 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 versus T-piece. |
| 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 versus T-piece. |
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 versus T-piece. |
| 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 versus T-piece. |
| 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 versus T-piece. |
| 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 versus T-piece. |
| 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 versus T-piece. |
| 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 versus T-piece. |
| 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 versus T-piece. |
| 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 versus T-piece. |
Countries
China
Contacts
Primary ContactJian-Xin Zhou, MD, PhD
Backup ContactShan-Shan Xu, MD
Outcome results
None listed