Comparison of Physiological Effects of Two Types of High-Flow Oxygen Therapy in Tracheostomized Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJian-Xin Zhou
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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%)
Trial design
Design model
Crossover
Treatments tested in this trial
Modified high flow tracheal oxygen
Procedure/SurgeryModified high-flow tracheal oxygen with flow rates of 40L/min and 60L/min will be performed.
Standard high flow tracheal oxygen
Procedure/SurgeryStandard high-flow tracheal oxygen with flow rates of 40 L/min and 60 L/min will be performed.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Modified high flow tracheal oxygenExperimental treatment 1 intervention
Group B: Standard high flow tracheal oxygenExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Mean expiratory airway pressure
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 hours2
Positive end-expiratory pressure
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 hours3
Change of end-expiatory lung volume
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 hoursSecondary outcomes
1
Respiratory rate
Respiratory rate will be measured during standard and modified high-flow tracheal oxygen.
Time frame
From enrollment to the end of treatment at 4 hours2
Tidal volume
Tidal volume will be measured during standard and modified high-flow tracheal oxygen.
Time frame
From enrollment to the end of treatment at 4 hours3
End-tidal carbon dioxide
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 hours4
Pulse oxygen saturation
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 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jian-Xin Zhou
Lead sponsor
Capital Medical University
Sponsor institution
Source ClinicalTrials.gov
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