Clinical trial NCT06816706: Comparison of Physiological Effects of Two High-Flow Tracheal Oxygen Versus T-Piece During Spontaneous Breathing Trials
Official title: Comparison of Physiological Effects of Two Types of High-Flow Tracheal Oxygen Versus T-Piece During Spontaneous Breathing Trials in Mechanically Ventilated Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Critical Care
Oxygen Therapy
Mechanical Ventilation
Keywords: high-flow tracheal oxygen
T piece
spontaneous breathing trial
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean expiratory airway pressure
timeFrame: From enrollment to the end of treatment at 4 hours
measure: Positive end-expiratory pressure
timeFrame: From enrollment to the end of treatment at 4 hours
measure: Change of end-expiatory lung volume
timeFrame: From enrollment to the end of treatment at 4 hours
Secondary outcomes:
measure: Respiratory rate
timeFrame: From enrollment to the end of treatment at 4 hours
measure: Tidal volume
timeFrame: From enrollment to the end of treatment at 4 hours
measure: End-tidal carbon dioxide
timeFrame: From enrollment to the end of treatment at 4 hours
measure: Pulse oxygen saturation
timeFrame: From enrollment to the end of treatment at 4 hours
measure: Esophageal pressure-time product
timeFrame: From enrollment to the end of treatment at 4 hours
measure: Tidal swing of esophageal pressure
timeFrame: From enrollment to the end of treatment at 4 hours
measure: Respiratory muscle pressure
timeFrame: From enrollment to the end of treatment at 4 hours
measure: Dynamic transpulmonary pressure
timeFrame: From enrollment to the end of treatment at 4 hours
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Shijitan Hospital
state: Beijing
Study officials:
affiliation: Capital Medical University
name: Jian-Xin Zhou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: