Beijing Shijitan Hospital
Beijing, Beijing Municipality, 100038, China
Location contact
Jian-Xin Zhou, MD, PhD
CONTACT
Shan-Shan Xu, MD
CONTACT
NCT Number: NCT06816745
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Beijing, Beijing Municipality, 100038, China
Jian-Xin Zhou, MD, PhD
CONTACT
Shan-Shan Xu, MD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Tracheostomy with stable spontaneous breathing.
Exclusion criteria
Modified high-flow tracheal oxygen with flow rates of 40L/min and 60L/min will be performed.
Standard high-flow tracheal oxygen with flow rates of 40 L/min and 60 L/min will be performed.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Jian-Xin Zhou, MD, PhD
CONTACT
Shan-Shan Xu, MD
CONTACT
Jian-Xin Zhou
Other
Comparison of Physiological Effects of Standard and Modified High-Flow Oxygen Therapy in Tracheostomized Patients
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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