Mechanical Ventilation WeaningHFTO-SBTNCT07864415
High-Flow Tracheal Oxygen During Spontaneous Breathing Trial
A study testing T-piece, HFTO 50, washout, HFTO 70, washout, PSV. and T-piece, HFTO 70, washout, HFTO 50, washout, PSV. in people with Mechanical Ventilation Weaning and Spontaneous Breathing Trial, run by Argentinian Intensive Care Society.
Trial summary
The purpose of this study is to find out whether high-flow tracheal oxygen (HFTO) delivered at flows greater than 60 L/min can increase end-expiratory lung volume (EELV) in intubated patients during a spontaneous breathing trial (SBT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Weaning, Spontaneous Breathing Trial, High Flow Oxygen Therapy
- What is being tested?
- T-piece, HFTO 50, washout, HFTO 70, washout, PSV. and T-piece, HFTO 70, washout, HFTO 50, washout, PSV.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Invasive mechanical ventilation ≥ 24 hours
- Presence of esophageal balloon catheter
- Meets criteria to start an SBT
- Signed informed consent by patient or responsible family member
Who cannot join
- Neuromuscular or neurodegenerative disease
- contraindication to electrical impedance tomography (e.g., implantable defibrillator)
- Impossible to place EIT electrode belt (e.g., wound dressings or chest drains)
- Elimination Criteria:
- Flow intolerance
- Behavioral/cognitive alterations that interrupt measurements in two consecutive attempts.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of High-flow Tracheal Oxygen on End-expiratory Lung Impedance and Work of Breathing in Intubated Patients During a Spontaneous Breathing Trial.
The purpose of this study is to find out whether high-flow tracheal oxygen (HFTO) delivered at flows greater than 60 L/min can increase end-expiratory lung volume (EELV) in intubated patients during a spontaneous breathing trial (SBT).
Weaning from mechanical ventilation can be difficult, especially in patients at higher risk of failure. During an SBT, losing positive end-expiratory pressure (PEEP) can cause the lungs to lose volume and make breathing harder by increasing the work of breathing (WOB). HFTO may help reduce the work of breathing, but previous studies using flows of 30-60 L/min did not consistently show an increase in EELV. Higher flows may create more airway pressure.
Therefore, the main question this study is trying to answer is: In intubated patients during an SBT, does HFTO at flows greater than 60 L/min increase EELV? The hypothesis is that HFTO at flows above 60 L/min will increase EELV during the SBT.
- Being tested
- T-piece, HFTO 50, washout, HFTO 70, washout, PSV., T-piece, HFTO 70, washout, HFTO 50, washout, PSV.
- Keywords
- Mechanical Ventilation, Weaning, Spontaneous Breathing Trial, High Flow Tracheal Oxygen, High Flow Oxygen Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-piece, HFTO 50, washout, HFTO 70, washout, PSV.Device
Participants randomized to this Sequence receive the following conditions during a spontaneous breathing trial (SBT):
T-piece (baseline) - 15 minutes
High-flow tracheal oxygen (HFTO) at 50 L/min - 15 minutes
Washout on T-piece - 15 minutes
HFTO at 70 L/min - 15 minutes
Washout on T-piece - 15 minutes
Pressure support ventilation (PSV) 7 cmH₂O / PEEP 0 cmH₂O - 15 minutes
Throughout the sequence, end-expiratory lung impedance (EELI), work of breathing (esophageal pressure-derived parameters), respiratory rate, SpO₂, hemodynamic variables, dyspnea, and diaphragmatic thickening fraction (DTF) are measured. This is one of two randomized crossover sequences; all participants receive all conditions in the order assigned by randomization.
T-piece, HFTO 70, washout, HFTO 50, washout, PSV.Device
Participants randomized to this Sequence receive the following conditions during a spontaneous breathing trial (SBT):
T-piece (baseline) - 15 minutes
High-flow tracheal oxygen (HFTO) at 70 L/min - 15 minutes
Washout on T-piece - 15 minutes
HFTO at 50 L/min - 15 minutes
Washout on T-piece - 15 minutes
Pressure support ventilation (PSV) 7 cmH₂O / PEEP 0 cmH₂O - 15 minutes
Throughout the sequence, end-expiratory lung impedance (EELI), work of breathing (esophageal pressure-derived parameters: ΔPes, PTPes, PTPes-min), respiratory rate, SpO₂, hemodynamic variables, dyspnea, and diaphragmatic thickening fraction (DTF) are measured. This is one of two randomized crossover sequences; all participants receive all conditions in the order assigned by randomization.
| Study group | Role | What they receive |
|---|---|---|
| Sequence A (HFTO 50 → HFTO 70) | Experimental | Not described Receives: Device: T-piece, HFTO 50, washout, HFTO 70, washout, PSV. |
| Sequence B (HFTO 70 → HFTO 50) | Experimental | Not described Receives: Device: T-piece, HFTO 70, washout, HFTO 50, washout, PSV. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in end-expiratory lung impedance (EELI) during spontaneous breathing trial
Change in global end-expiratory lung impedance (ΔEELI; arbitrary units), measured by electrical impedance tomography (EIT), expressed as tidal variation of the first stable respiratory cycle, among four conditions in intubated adult patients during a spontaneous breathing trial: T-piece, high-flow tracheal oxygen (HFTO) at 50 L/min, HFTO at 70 L/min, and pressure support ventilation (PSV) 7 cmH₂O / PEEP 0 cmH₂O. Because this is a randomized crossover study, the primary comparison is within-subject across conditions.
Measured: Baseline (t0, T-piece); after 15 minutes of HFTO 50 L/min; after 15 minutes of HFTO 70 L/min; after 15 minutes of PSV 7 cmH₂O/PEEP 0 cmH₂O; with 15 minutes T-piece washout periods between conditions.
Secondary outcomes (3)
Change in esophageal pressure swing
Change in esophageal pressure swing (ΔPes; units cmH2O) across conditions (T-piece, HFTO 50 L/min, HFTO 70 L/min, PSV 7 cmH₂O / PEEP 0 cmH₂O).
Measured: Baseline (t0, T-piece); after 15 minutes of HFTO 50 L/min; after 15 minutes of HFTO 70 L/min; after 15 minutes of PSV 7 cmH₂O/PEEP 0 cmH₂O; with 15 minutes T-piece washout periods between conditions.
Change in Diaphragmatic Thickening Fraction (DTF)
Change in diaphragmatic thickening fraction (DTF; Units percentage) measured by ultrasonography, calculated as:
DTF = [(thickness at end-inspiration - thickness at end-expiration) / thickness at end-expiration] × 100.
Measured: Baseline (t0, T-piece); at the end of 15 minutes of HFTO 50 L/min; at the end of 15 minutes of HFTO 70 L/min; at the end of 15 minutes of PSV 7 cmH₂O/PEEP 0 cmH₂O; with 15 minutes T-piece washout periods between conditions.
Respiratory rate
Number of ventilatory cicles per minute
Measured: Baseline (t0, T-piece); after 15 minutes of HFTO 50 L/min; after 15 minutes of HFTO 70 L/min; after 15 minutes of PSV 7 cmH₂O/PEEP 0 cmH₂O; with T-piece washout periods between conditions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Mechanical Ventilation WeaningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Argentinian Intensive Care Society
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gustavo Plotnikow, Argentinian Intensive Care Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07864415
- Sponsor's protocol ID
- PRIISA 20291
- Acronym
- HFTO-SBT
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.
PubMed 10793162Baydur A, Behrakis PK, Zin WA, Jaeger M, Milic-Emili J. A simple method for assessing the validity of the esophageal balloon technique. Am Rev Respir Dis. 1982 Nov;126(5):788-91. doi: 10.1164/arrd.1982.126.5.788.
PubMed 7149443Plotnikow GA, Thille AW, Vasquez DN, Pratto RA, Quiroga CM, Andrich ME, Dorado JH, Gomez RS, D'Annunzio PA, Scapellato JL, Intile D. Effects of High-Flow Nasal Cannula on End-Expiratory Lung Impedance in Semi-Seated Healthy Subjects. Respir Care. 2018 Aug;63(8):1016-1023. doi: 10.4187/respcare.06031. Epub 2018 Jun 26.
PubMed 29945910Parke RL, Bloch A, McGuinness SP. Effect of Very-High-Flow Nasal Therapy on Airway Pressure and End-Expiratory Lung Impedance in Healthy Volunteers. Respir Care. 2015 Oct;60(10):1397-403. doi: 10.4187/respcare.04028. Epub 2015 Sep 1.
PubMed 26329355Stripoli T, Spadaro S, Di Mussi R, Volta CA, Trerotoli P, De Carlo F, Iannuzziello R, Sechi F, Pierucci P, Staffieri F, Bruno F, Camporota L, Grasso S. High-flow oxygen therapy in tracheostomized patients at high risk of weaning failure. Ann Intensive Care. 2019 Jan 7;9(1):4. doi: 10.1186/s13613-019-0482-2.
PubMed 30617626Natalini D, Grieco DL, Santantonio MT, Mincione L, Toni F, Anzellotti GM, Eleuteri D, Di Giannatale P, Antonelli M, Maggiore SM. Physiological effects of high-flow oxygen in tracheostomized patients. Ann Intensive Care. 2019 Oct 7;9(1):114. doi: 10.1186/s13613-019-0591-y.
PubMed 31591659Corley A, Edwards M, Spooner AJ, Dunster KR, Anstey C, Fraser JF. High-flow oxygen via tracheostomy improves oxygenation in patients weaning from mechanical ventilation: a randomised crossover study. Intensive Care Med. 2017 Mar;43(3):465-467. doi: 10.1007/s00134-016-4634-7. Epub 2016 Nov 30. No abstract available.
PubMed 27904928Janssen ML, Weller D, Endeman H, Heunks LM, Wils EJ. Physiological Effects of High-Flow Tracheal Oxygen in Tracheostomized Patients Weaning From Mechanical Ventilation. Respir Care. 2024 Sep 26;69(10):1336-1344. doi: 10.4187/respcare.11755.
PubMed 38772682Lopez-Rubio AG, Torres-Suarez Y, Ortiz-Moreno DC, Perez-Velazquez CA, Castillo-Morales LM, Mora-Salamanca AF, Alvarado-Sanchez JI. High-flow tracheal therapy vs. tracheostomy mask in weaning: insights from a propensity-matched cohort. BMC Pulm Med. 2025 Nov 21;26(1):9. doi: 10.1186/s12890-025-04037-6.
PubMed 41272426Fernandez MM, Gonzalez-Castro A, Magret M, Bouza MT, Ibanez M, Garcia C, Balerdi B, Mas A, Arauzo V, Anon JM, Ruiz F, Ferreres J, Tomas R, Alabert M, Tizon AI, Altaba S, Llamas N, Fernandez R. Reconnection to mechanical ventilation for 1 h after a successful spontaneous breathing trial reduces reintubation in critically ill patients: a multicenter randomized controlled trial. Intensive Care Med. 2017 Nov;43(11):1660-1667. doi: 10.1007/s00134-017-4911-0. Epub 2017 Sep 22.
PubMed 28936675Khazaei O, Laffey CM, Sheerin R, McNicholas BA, Pham T, Heunks L, Bellani G, Brochard L, Simpkin AJ, Laffey JG; WEAN SAFE Investigators. Impact of comorbidities on management and outcomes of patients weaning from invasive mechanical ventilation: insights from the WEAN SAFE study. Crit Care. 2025 Mar 13;29(1):114. doi: 10.1186/s13054-025-05341-7.
PubMed 40082949Pham T, Heunks L, Bellani G, Madotto F, Aragao I, Beduneau G, Goligher EC, Grasselli G, Laake JH, Mancebo J, Penuelas O, Piquilloud L, Pesenti A, Wunsch H, van Haren F, Brochard L, Laffey JG; WEAN SAFE Investigators. Weaning from mechanical ventilation in intensive care units across 50 countries (WEAN SAFE): a multicentre, prospective, observational cohort study. Lancet Respir Med. 2023 May;11(5):465-476. doi: 10.1016/S2213-2600(22)00449-0. Epub 2023 Jan 21.
PubMed 36693401
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High-flow Tracheal Oxygen on End-expiratory Lung Impedance and Work of Breathing in Intubated Patients During a Spontaneous Breathing Trial.
- ClinicalTrials.gov ID
- NCT07864415
- Acronym / sponsor ID
- HFTO-SBT / PRIISA 20291
- Keywords
- Mechanical Ventilation, Weaning, Spontaneous Breathing Trial, High Flow Tracheal Oxygen, High Flow Oxygen Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Argentinian Intensive Care SocietyUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 7 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out whether high-flow tracheal oxygen (HFTO) delivered at flows greater than 60 L/min can increase end-expiratory lung volume (EELV) in intubated patients during a spontaneous breathing trial (SBT).
Weaning from mechanical ventilation can be difficult, especially in patients at higher risk of failure. During an SBT, losing positive end-expiratory pressure (PEEP) can cause the lungs to lose volume and make breathing harder by increasing the work of breathing (WOB). HFTO may help reduce the work of breathing, but previous studies using flows of 30-60 L/min did not consistently show an increase in EELV. Higher flows may create more airway pressure.
Therefore, the main question this study is trying to answer is: In intubated patients during an SBT, does HFTO at flows greater than 60 L/min increase EELV? The hypothesis is that HFTO at flows above 60 L/min will increase EELV during the SBT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A (HFTO 50 → HFTO 70) | Experimental | Device: T-piece, HFTO 50, washout, HFTO 70, washout, PSV. |
| Sequence B (HFTO 70 → HFTO 50) | Experimental | Device: T-piece, HFTO 70, washout, HFTO 50, washout, PSV. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Invasive mechanical ventilation ≥ 24 hours
- Presence of esophageal balloon catheter
- Meets criteria to start an SBT
- Signed informed consent by patient or responsible family member
Key exclusion criteria (6 listed)
- Neuromuscular or neurodegenerative disease
- contraindication to electrical impedance tomography (e.g., implantable defibrillator)
- Impossible to place EIT electrode belt (e.g., wound dressings or chest drains)
- Flow intolerance
- Behavioral/cognitive alterations that interrupt measurements in two consecutive attempts.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T-piece, HFTO 50, washout, HFTO 70, washout, PSV.Participants randomized to this Sequence receive the following conditions during a spontaneous breathing trial (SBT): T-piece (baseline) - 15 minutes High-flow tracheal oxygen (HFTO) at 50 L/min - 15 minutes Washout on T-piece - 15 minutes HFTO at 70 L/min - 15 minutes Washout on T-piece - 15 minutes Pressure support ventilation (PSV) 7 cmH₂O / PEEP 0 cmH₂O - 15 minutes Throughout the sequence, end-expiratory lung impedance (EELI), work of breathing (esophageal pressure-derived parameters), respiratory rate, SpO₂, hemodynamic variables, dyspnea, and diaphragmatic thickening fraction (DTF) are measured. This is one of two randomized crossover sequences; all participants receive all conditions in the order assigned by randomization. | Device | Sequence A (HFTO 50 → HFTO 70) |
| T-piece, HFTO 70, washout, HFTO 50, washout, PSV.Participants randomized to this Sequence receive the following conditions during a spontaneous breathing trial (SBT): T-piece (baseline) - 15 minutes High-flow tracheal oxygen (HFTO) at 70 L/min - 15 minutes Washout on T-piece - 15 minutes HFTO at 50 L/min - 15 minutes Washout on T-piece - 15 minutes Pressure support ventilation (PSV) 7 cmH₂O / PEEP 0 cmH₂O - 15 minutes Throughout the sequence, end-expiratory lung impedance (EELI), work of breathing (esophageal pressure-derived parameters: ΔPes, PTPes, PTPes-min), respiratory rate, SpO₂, hemodynamic variables, dyspnea, and diaphragmatic thickening fraction (DTF) are measured. This is one of two randomized crossover sequences; all participants receive all conditions in the order assigned by randomization. | Device | Sequence B (HFTO 70 → HFTO 50) |
Primary outcome
Change in end-expiratory lung impedance (EELI) during spontaneous breathing trial
Time frame: Baseline (t0, T-piece); after 15 minutes of HFTO 50 L/min; after 15 minutes of HFTO 70 L/min; after 15 minutes of PSV 7 cmH₂O/PEEP 0 cmH₂O; with 15 minutes T-piece washout periods between conditions.
Change in global end-expiratory lung impedance (ΔEELI; arbitrary units), measured by electrical impedance tomography (EIT), expressed as tidal variation of the first stable respiratory cycle, among four conditions in intubated adult patients during a spontaneous breathing trial: T-piece, high-flow tracheal oxygen (HFTO) at 50 L/min, HFTO at 70 L/min, and pressure support ventilation (PSV) 7 cmH₂O / PEEP 0 cmH₂O. Because this is a randomized crossover study, the primary comparison is within-subject across conditions.
3 secondary outcomes
Change in esophageal pressure swing
Time frame: Baseline (t0, T-piece); after 15 minutes of HFTO 50 L/min; after 15 minutes of HFTO 70 L/min; after 15 minutes of PSV 7 cmH₂O/PEEP 0 cmH₂O; with 15 minutes T-piece washout periods between conditions.
Change in Diaphragmatic Thickening Fraction (DTF)
Time frame: Baseline (t0, T-piece); at the end of 15 minutes of HFTO 50 L/min; at the end of 15 minutes of HFTO 70 L/min; at the end of 15 minutes of PSV 7 cmH₂O/PEEP 0 cmH₂O; with 15 minutes T-piece washout periods between conditions.
Respiratory rate
Time frame: Baseline (t0, T-piece); after 15 minutes of HFTO 50 L/min; after 15 minutes of HFTO 70 L/min; after 15 minutes of PSV 7 cmH₂O/PEEP 0 cmH₂O; with T-piece washout periods between conditions.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Background: PubMed 10793162Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.
- Background: PubMed 7149443Baydur A, Behrakis PK, Zin WA, Jaeger M, Milic-Emili J. A simple method for assessing the validity of the esophageal balloon technique. Am Rev Respir Dis. 1982 Nov;126(5):788-91. doi: 10.1164/arrd.1982.126.5.788.
- Background: PubMed 29945910Plotnikow GA, Thille AW, Vasquez DN, Pratto RA, Quiroga CM, Andrich ME, Dorado JH, Gomez RS, D'Annunzio PA, Scapellato JL, Intile D. Effects of High-Flow Nasal Cannula on End-Expiratory Lung Impedance in Semi-Seated Healthy Subjects. Respir Care. 2018 Aug;63(8):1016-1023. doi: 10.4187/respcare.06031. Epub 2018 Jun 26.
- Background: PubMed 26329355Parke RL, Bloch A, McGuinness SP. Effect of Very-High-Flow Nasal Therapy on Airway Pressure and End-Expiratory Lung Impedance in Healthy Volunteers. Respir Care. 2015 Oct;60(10):1397-403. doi: 10.4187/respcare.04028. Epub 2015 Sep 1.
- Background: PubMed 30617626Stripoli T, Spadaro S, Di Mussi R, Volta CA, Trerotoli P, De Carlo F, Iannuzziello R, Sechi F, Pierucci P, Staffieri F, Bruno F, Camporota L, Grasso S. High-flow oxygen therapy in tracheostomized patients at high risk of weaning failure. Ann Intensive Care. 2019 Jan 7;9(1):4. doi: 10.1186/s13613-019-0482-2.
- Background: PubMed 31591659Natalini D, Grieco DL, Santantonio MT, Mincione L, Toni F, Anzellotti GM, Eleuteri D, Di Giannatale P, Antonelli M, Maggiore SM. Physiological effects of high-flow oxygen in tracheostomized patients. Ann Intensive Care. 2019 Oct 7;9(1):114. doi: 10.1186/s13613-019-0591-y.
- Background: PubMed 27904928Corley A, Edwards M, Spooner AJ, Dunster KR, Anstey C, Fraser JF. High-flow oxygen via tracheostomy improves oxygenation in patients weaning from mechanical ventilation: a randomised crossover study. Intensive Care Med. 2017 Mar;43(3):465-467. doi: 10.1007/s00134-016-4634-7. Epub 2016 Nov 30. No abstract available.
- Background: PubMed 38772682Janssen ML, Weller D, Endeman H, Heunks LM, Wils EJ. Physiological Effects of High-Flow Tracheal Oxygen in Tracheostomized Patients Weaning From Mechanical Ventilation. Respir Care. 2024 Sep 26;69(10):1336-1344. doi: 10.4187/respcare.11755.
- Background: PubMed 41272426Lopez-Rubio AG, Torres-Suarez Y, Ortiz-Moreno DC, Perez-Velazquez CA, Castillo-Morales LM, Mora-Salamanca AF, Alvarado-Sanchez JI. High-flow tracheal therapy vs. tracheostomy mask in weaning: insights from a propensity-matched cohort. BMC Pulm Med. 2025 Nov 21;26(1):9. doi: 10.1186/s12890-025-04037-6.
- Background: PubMed 28936675Fernandez MM, Gonzalez-Castro A, Magret M, Bouza MT, Ibanez M, Garcia C, Balerdi B, Mas A, Arauzo V, Anon JM, Ruiz F, Ferreres J, Tomas R, Alabert M, Tizon AI, Altaba S, Llamas N, Fernandez R. Reconnection to mechanical ventilation for 1 h after a successful spontaneous breathing trial reduces reintubation in critically ill patients: a multicenter randomized controlled trial. Intensive Care Med. 2017 Nov;43(11):1660-1667. doi: 10.1007/s00134-017-4911-0. Epub 2017 Sep 22.
- Background: PubMed 40082949Khazaei O, Laffey CM, Sheerin R, McNicholas BA, Pham T, Heunks L, Bellani G, Brochard L, Simpkin AJ, Laffey JG; WEAN SAFE Investigators. Impact of comorbidities on management and outcomes of patients weaning from invasive mechanical ventilation: insights from the WEAN SAFE study. Crit Care. 2025 Mar 13;29(1):114. doi: 10.1186/s13054-025-05341-7.
- Background: PubMed 36693401Pham T, Heunks L, Bellani G, Madotto F, Aragao I, Beduneau G, Goligher EC, Grasselli G, Laake JH, Mancebo J, Penuelas O, Piquilloud L, Pesenti A, Wunsch H, van Haren F, Brochard L, Laffey JG; WEAN SAFE Investigators. Weaning from mechanical ventilation in intensive care units across 50 countries (WEAN SAFE): a multicentre, prospective, observational cohort study. Lancet Respir Med. 2023 May;11(5):465-476. doi: 10.1016/S2213-2600(22)00449-0. Epub 2023 Jan 21.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing T-piece, HFTO 50, washout, HFTO 70, washout, PSV. and T-piece, HFTO 70, washout, HFTO 50, washout, PSV. in people with Mechanical Ventilation Weaning and Spontaneous Breathing Trial, run by Argentinian Intensive Care Society.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gustavo A Plotnikow, IP (5491164543771, gplotnikow@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in end-expiratory lung impedance (EELI) during spontaneous breathing trial (time frame: Baseline (t0, T-piece); after 15 minutes of HFTO 50 L/min; after 15 minutes of HFTO 70 L/min; after 15 minutes of PSV 7 cmH₂O/PEEP 0 cmH₂O; with 15 minutes T-piece washout periods between conditions.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07864415, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.