Comparison of Physiological Effects of Two High-Flow Tracheal Oxygen Versus T-Piece During Spontaneous Breathing Trials
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJian-Xin Zhou
About this trial
Spontaneous breathing trials (SBT) are essential for assessing extubation tolerance, yet optimal approaches are debated. High-flow nasal oxygen offers benefits like precise oxygen delivery, flow-related positive end-expiratory pressure generation and improved lung function. While high-flow tracheal oxygen can also be used as an SBT method, it has reduced physiological effects due to bypassing the upper airway with a more open circuit. To enhance this limitation, investigators developed a modified high-flow tracheal oxygen tube with a smaller expiratory end diameter to increase expiratory resistance and airway pressure. This is a prospective randomized crossover study that aims to compare the physiological effects of standard and modified high-flow tracheal oxygen versus T-piece during SBT.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Mechanical ventilation for more than 24 hours
Considered by the physicians for the readiness to wean and ready for spontaneous breathing trials
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-40L/min
Procedure/SurgeryModified high-flow tracheal oxygen with a flow rate of 40L/min will be performed.
Standard high flow tracheal oxygen-40L/min
Procedure/SurgeryStandard high-flow tracheal oxygen with a flow rate of 40 L/min will be performed.
T-piece
Procedure/SurgeryT-piece will be performed.
Modified high-flow tracheal oxygen-60L/min
Procedure/SurgeryModified high-flow tracheal oxygen with a flow rate of 60L/min will be performed.
Standard high-flow tracheal oxygen-60 L/min
Procedure/SurgeryStandard high-flow tracheal oxygen with a flow rate of 60 L/min will be performed.
Treatment groups
20 Participants
are divided into 5 treatment groupsGroup A: Modified high flow tracheal oxygen-40L/minExperimental treatment 1 intervention
Group B: Standard high flow tracheal oxygen-40L/minExperimental treatment 1 intervention
Group C: T-pieceExperimental treatment 1 intervention
Group D: Modified high-flow tracheal oxygen-60L/minExperimental treatment 1 intervention
Group E: Standard high-flow tracheal oxygen-60L/minExperimental 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 versus T-piece.
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 versus T-piece.
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 versus T-piece.
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 versus T-piece.
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 versus T-piece.
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 versus T-piece.
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 versus T-piece.
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