Comparison of Physiological Effects of Two High-Flow Tracheal Oxygen Versus T-Piece During Spontaneous Breathing Trials

Last updated: March 20, 2025
Sponsor: Jian-Xin Zhou
Overall Status: Active - Recruiting

Phase

N/A

Condition

Transdermal Continuous Oxygen Therapy (Tcot)

Treatment

Standard high flow tracheal oxygen-40L/min

T-piece

Modified high flow tracheal oxygen-40L/min

Clinical Study ID

NCT06816706
IIT2024-157-002
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Mechanical ventilation for more than 24 hours

  2. Considered by the physicians for the readiness to wean and ready for spontaneousbreathing trials

Exclusion

Exclusion Criteria:

  1. Age younger than 18 years old

  2. Pregnancy

  3. Hemodynamic instability (mean arterial pressure <60 mmHg, heart rate >140 or <60bpm)

  4. Respiratory and oxygenation instability (respiratory rate > 35bpm or oxygensaturation 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) (implantabledefibrillator)

  9. Anticipating withdrawal of life support

Study Design

Total Participants: 20
Treatment Group(s): 5
Primary Treatment: Standard high flow tracheal oxygen-40L/min
Phase:
Study Start date:
March 01, 2025
Estimated Completion Date:
December 30, 2025

Study 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.

Connect with a study center

  • Beijing Shijitan Hospital

    Beijing, Beijing 100038
    China

    Active - Recruiting

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