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NCT Number: NCT06816706

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Mechanical ventilation for more than 24 hours
  • Considered by the physicians for the readiness to wean and ready for spontaneous breathing trials

Exclusion criteria

  • 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

Treatment and study plan

Modified high flow tracheal oxygen-40L/min

Procedure

Modified high-flow tracheal oxygen with a flow rate of 40L/min will be performed.

Standard high flow tracheal oxygen-40L/min

Procedure

Standard high-flow tracheal oxygen with a flow rate of 40 L/min will be performed.

T-piece

Procedure

T-piece will be performed.

Modified high-flow tracheal oxygen-60L/min

Procedure

Modified high-flow tracheal oxygen with a flow rate of 60L/min will be performed.

Standard high-flow tracheal oxygen-60 L/min

Procedure

Standard high-flow tracheal oxygen with a flow rate of 60 L/min will be performed.

Primary outcomes

  1. Mean expiratory airway pressure

    Time frame: 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.

  2. Positive end-expiratory pressure

    Time frame: 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.

  3. Change of end-expiatory lung volume

    Time frame: 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 outcomes

  1. Respiratory rate

    Time frame: 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.

  2. Tidal volume

    Time frame: 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.

  3. End-tidal carbon dioxide

    Time frame: 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.

  4. Pulse oxygen saturation

    Time frame: 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.

  5. Esophageal pressure-time product

    Time frame: 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.

  6. Tidal swing of esophageal pressure

    Time frame: 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.

  7. Respiratory muscle pressure

    Time frame: 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.

  8. Dynamic transpulmonary pressure

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jian-Xin Zhou, MD, PhD

CONTACT

[email protected]

8610 6392 6666

Shan-Shan Xu, MD

CONTACT

[email protected]

8618501219133

Sponsors and collaborators

Lead sponsor

Jian-Xin Zhou

Other

Registry information

Official study title

Comparison of Physiological Effects of Two Types of High-Flow Tracheal Oxygen Versus T-Piece During Spontaneous Breathing Trials in Mechanically Ventilated Patients

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 10, 2025
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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