TracheostomyTRACFLOWNCT07714564
Trcheal High-flow for Weaning From Mechanical Ventilation
A study testing Oxygen therapy in people with Tracheostomy and Mechanical Ventilation, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Multicentre randomized trial to determine whether tracheal high-flow nasal oxygen can improve weaning outcome vs. conventional oxygen therapy in critically ill tracheostomized patients who are hypoxemic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheostomy, Mechanical Ventilation, Hypoxemic Respiratory Failure
- What is being tested?
- Oxygen therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2026to 30 Apr 2029
- 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
- Tracheostomy
- Plan to receive weaning from mechanical ventilation after more than 48 hours of mechanical ventilation
- Hypoxemia (PaO2/FiO2<300) while on mechanical ventilation
Who cannot join
- anticipated need for long-term mechanical ventilation
- scheduled reconnections to mechanical ventilation
- neuromuscular disease
- chronic ventilator dependence
- planned nocturnal home ventilation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Tracheal High-flow vs. Conventional Oxygen for Weaning From Mechanical Ventilation in Tracheostomized Patients: an Open-label, Multicentre, Randomized Trial
Multicentre randomized trial to determine whether tracheal high-flow nasal oxygen can improve weaning outcome vs. conventional oxygen therapy in critically ill tracheostomized patients who are hypoxemic.
- Being tested
- Oxygen therapy
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen therapyOther
Oxygen supplementation delivered to the patient after disconnection from mechanical ventilation.
| Study group | Role | What they receive |
|---|---|---|
| High-flow oxygen | Experimental | Maximum tolerated flow (up to 50-60 L/min), humidification chamber temperature set at 37 °C and FiO2 titrated to obtain SpO2 ≥92% and ≤98%, or 88%-92% for hypercapnic patients. Flow reduction will be allowed in case of intolerance and/or according to patients' requirements: flow ≥30 L/min will be mandatory in all enrolled patients.
Weaning from high-flow will not be considered before 24 hours from study enrolment and will be discouraged until the patient is considered for intensive care unit discharge.
After weaning, patients will receive conventional oxygen. Receives: Other: Oxygen therapy |
| Conventional oxygen | Active comparator | Patients will receive standard oxygen therapy via a heat and moisture exchanger (Tracheolife) or a Venturi tracheal mask device connected to a humidified source of oxygen. Oxygen flow or VenturiMask FiO2 will be titrated to obtain SpO2 ≥92% and ≤98%, or 88%-92% for hypercapnic patients. The use of tracheal high-flow will not be allowed under any circumstances in patients in this group. Receives: Other: Oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Succesful weaning
proportion of patients weaned from mechanical ventilation at day 7 after randomization. Weaning is defined as being disconnected from the mechanical ventilator on day 7 and remaining off the ventilator for at least the subsequent 48 consecutive hours without reconnection.
Measured: Day 7 after randomization
Secondary outcomes (11)
Succesful weaning - Day 28
- Proportion of patient successfully weaned from mechanical ventilation on day 28 after randomization
Measured: Day 28 after randomization
Time to successful weaning from mechanical ventilation
Weaning from mechanical ventilation and not reconnected up to hospital discharge-alive at 90 days.
Measured: 90 days
Number of reconnections required to the ventilator
Number of reconnections required to the ventilator before achieving succesful weaning.
Measured: 90 days
Mechanical ventilation-free days
Days free of mechanical ventilation
Measured: Day 28, 60 and 90
Intensive care unit-free days
Days in which the patient is not in the Intensive care unit
Measured: Day 28, 60 and 90
In-intensive care unit mortality
Mortality in the intensive care unit
Measured: 90 days
In-hospital care unit mortality
Mortality at hospital discharge
Measured: 90 days
90-day mortality
mortality at 90 days
Measured: 90 days
Pneumonia
Rate of hospital-acquired pneumonia
Measured: 90 days
Shock
Rate of shock
Measured: 90 days
Time to decannulation
Time to successful decannulation of tracheostomy cannula
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TracheostomyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Domenico Luca Grieco, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07714564
- Sponsor's protocol ID
- 27442
- Acronym
- TRACFLOW
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracheal High-flow vs. Conventional Oxygen for Weaning From Mechanical Ventilation in Tracheostomized Patients: an Open-label, Multicentre, Randomized Trial
- ClinicalTrials.gov ID
- NCT07714564
- Acronym / sponsor ID
- TRACFLOW / 27442
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 20 Jul 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.
Multicentre randomized trial to determine whether tracheal high-flow nasal oxygen can improve weaning outcome vs. conventional oxygen therapy in critically ill tracheostomized patients who are hypoxemic.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| High-flow oxygen | Experimental | Other: Oxygen therapyMaximum tolerated flow (up to 50-60 L/min), humidification chamber temperature set at 37 °C and FiO2 titrated to obtain SpO2 ≥92% and ≤98%, or 88%-92% for hypercapnic patients. Flow reduction will be allowed in case of intolerance and/or according to patients' requirements: flow ≥30 L/min will be mandatory in all enrolled patients. Weaning from high-flow will not be considered before 24 hours from study enrolment and will be discouraged until the patient is considered for intensive care unit discharge. After weaning, patients will receive conventional oxygen. |
| Conventional oxygen | Active comparator | Other: Oxygen therapyPatients will receive standard oxygen therapy via a heat and moisture exchanger (Tracheolife) or a Venturi tracheal mask device connected to a humidified source of oxygen. Oxygen flow or VenturiMask FiO2 will be titrated to obtain SpO2 ≥92% and ≤98%, or 88%-92% for hypercapnic patients. The use of tracheal high-flow will not be allowed under any circumstances in patients in this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Tracheostomy
- Plan to receive weaning from mechanical ventilation after more than 48 hours of mechanical ventilation
- Hypoxemia (PaO2/FiO2<300) while on mechanical ventilation
Key exclusion criteria (5 listed)
- anticipated need for long-term mechanical ventilation
- scheduled reconnections to mechanical ventilation
- neuromuscular disease
- chronic ventilator dependence
- planned nocturnal home ventilation
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 |
|---|---|---|
| Oxygen therapyOxygen supplementation delivered to the patient after disconnection from mechanical ventilation. | Other | Conventional oxygen, High-flow oxygen |
Primary outcome
Succesful weaning
Time frame: Day 7 after randomization
proportion of patients weaned from mechanical ventilation at day 7 after randomization. Weaning is defined as being disconnected from the mechanical ventilator on day 7 and remaining off the ventilator for at least the subsequent 48 consecutive hours without reconnection.
11 secondary outcomes
Succesful weaning - Day 28
Time frame: Day 28 after randomization
Time to successful weaning from mechanical ventilation
Time frame: 90 days
Number of reconnections required to the ventilator
Time frame: 90 days
Mechanical ventilation-free days
Time frame: Day 28, 60 and 90
Intensive care unit-free days
Time frame: Day 28, 60 and 90
In-intensive care unit mortality
Time frame: 90 days
In-hospital care unit mortality
Time frame: 90 days
90-day mortality
Time frame: 90 days
Pneumonia
Time frame: 90 days
Shock
Time frame: 90 days
Time to decannulation
Time frame: 90 days
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 20 Jul 2026.
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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.
Domenico Luca Grieco principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen therapy in people with Tracheostomy and Mechanical Ventilation, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 3 inclusion and 5 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 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Domenico Luca Grieco, MD (+393397681623, domenicoluca.grieco@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Succesful weaning (time frame: Day 7 after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2026.