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NCT Number: NCT06816745

Comparison of Physiological Effects of Two Types of High-Flow Oxygen Therapy in Tracheostomized Patients

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.

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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

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Tracheostomy with stable spontaneous breathing.

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

Procedure

Modified high-flow tracheal oxygen with flow rates of 40L/min and 60L/min will be performed.

Standard high flow tracheal oxygen

Procedure

Standard high-flow tracheal oxygen with flow rates of 40 L/min and 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.

  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.

  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.

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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

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 Standard and Modified High-Flow Oxygen Therapy in Tracheostomized Patients

Important dates

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