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NCT06816706
Comparison of Physiological Effects of Two High-Flow Tracheal Oxygen Versus T-Piece During Spontaneous Breathing Trials
NA trial testing Modified high flow tracheal oxygen-40L/min in Critical Care in 20 participants. Currently enrolling.
30 November 2025
Quick facts
| Lead sponsor | Jian-Xin Zhou |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 1 March 2025 |
| Primary completion | 30 November 2025 |
| Estimated completion | 30 December 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Modified high flow tracheal oxygen-40L/min
- Standard high flow tracheal oxygen-40L/min
- T-piece
- Modified high-flow tracheal oxygen-60L/min
- Standard high-flow tracheal oxygen-60 L/min
Conditions studied
- Critical Care — all drugs for Critical Care →
- Oxygen Therapy — all drugs for Oxygen Therapy →
- Mechanical Ventilation — all drugs for Mechanical Ventilation →
Sponsor
Jian-Xin Zhou
Who can join
18 and older, any sex, with Critical Care or Oxygen Therapy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Physiological effects of high-flow oxygen via endotracheal tube versus T-piece strategies during spontaneous breathing trials: a study protocol and statistical analysis for a single-centre randomised crossover study.
Xu SS, Zhang RZ, An X, Miao MY, et al · · 2025 · PMID 40962338 · DOI 10.1136/bmjopen-2025-105360
Verify or expand the search:
- PubMed search for NCT06816706
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Jian-Xin Zhou trials
Trials by the same sponsor.
- NCT07129174 — Pulmonary Microbiota Changes and Clinical Outcomes in Neurosurgical ICU Patients With Artificial Airways · not yet recruiting
- NCT06968793 — Use of Endotracheal Tube Cuff Pressure to Assess Inspiratory Effort During Pressure Support Ventilation · NA · completed
- NCT06970990 — Use of Nasal Pressure to Assess Inspiratory Effort Under Different Oxygen Treatments · NA · recruiting
- NCT06816745 — Comparison of Physiological Effects of Two Types of High-Flow Oxygen Therapy in Tracheostomized Patients · NA · not yet recruiting
- NCT05950893 — The Clinical Feasibility and Validity of PMIvent to Access Inspiratory Effort During Pressure Support Ventilation · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06816706 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jian-Xin Zhou
- Last refreshed: 21 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06816706.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing