Comparison of Physiological Effects of Two Types of High-Flow Oxygen Therapy in Tracheostomized Patients
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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Modified high flow tracheal oxygen, Standard high flow tracheal oxygen.
- Who it may be relevant to
- Registry conditions: Critical Care, Oxygen Therapy, Tracheostomy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Physiological Effects of Standard and Modified High-Flow Oxygen Therapy in Tracheostomized Patients
Overview
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.
Detailed description
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.
Interventions
- Procedure Modified high flow tracheal oxygen
Modified high-flow tracheal oxygen with flow rates of 40L/min and 60L/min will be performed. - Procedure Standard high flow tracheal oxygen
Standard high-flow tracheal oxygen with flow rates of 40 L/min and 60 L/min will be performed.
Primary outcome measures
- Mean expiratory airway pressure [Time frame: From enrollment to the end of treatment at 4 hours]
- Positive end-expiratory pressure [Time frame: From enrollment to the end of treatment at 4 hours]
- Change of end-expiatory lung volume [Time frame: From enrollment to the end of treatment at 4 hours]
Secondary outcome measures (8)
- Respiratory rate [Time frame: From enrollment to the end of treatment at 4 hours]
- Tidal volume [Time frame: From enrollment to the end of treatment at 4 hours]
- End-tidal carbon dioxide [Time frame: From enrollment to the end of treatment at 4 hours]
- Pulse oxygen saturation [Time frame: From enrollment to the end of treatment at 4 hours]
- Esophageal pressure-time product [Time frame: From enrollment to the end of treatment at 4 hours]
- Tidal swing of esophageal pressure [Time frame: From enrollment to the end of treatment at 4 hours]
- Respiratory muscle pressure [Time frame: From enrollment to the end of treatment at 4 hours]
- Dynamic transpulmonary pressure [Time frame: From enrollment to the end of treatment at 4 hours]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Shijitan Hospital — Beijing
Identifiers
NCT: NCT06816745 · IIT2024-158-002