Comparison of Physiological Effects of Two Types of High-Flow Oxygen Therapy in Tracheostomized Patients
NCT ID: NCT06816745
Last Updated: 2025-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
20 participants
INTERVENTIONAL
2025-02-20
2025-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Modified high flow tracheal oxygen
Modified high-flow tracheal oxygen with flow rates of 40L/ min and 60L/min will be performed in tracheostomized patients.
Modified high flow tracheal oxygen
Modified high-flow tracheal oxygen with flow rates of 40L/min and 60L/min will be performed.
Standard high flow tracheal oxygen
Standard high-flow tracheal oxygen with flow rates of 40 L/min and 60 L/min will be performed in tracheostomized patients.
Standard high flow tracheal oxygen
Standard high-flow tracheal oxygen with flow rates of 40 L/min and 60 L/min will be performed.
Interventions
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Modified high flow tracheal oxygen
Modified high-flow tracheal oxygen with flow rates of 40L/min and 60L/min will be performed.
Standard high flow tracheal oxygen
Standard high-flow tracheal oxygen with flow rates of 40 L/min and 60 L/min will be performed.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Jian-Xin Zhou
OTHER
Responsible Party
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Jian-Xin Zhou
Professor
Principal Investigators
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Jian-Xin Zhou, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Capital Medical University
Locations
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Beijing Shijitan Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IIT2024-158-002
Identifier Type: -
Identifier Source: org_study_id
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