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NCT Number: NCT07714564

Trcheal High-flow for Weaning From Mechanical Ventilation

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.

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Key information

Conditions

Tracheostomy Hypoxemic Respiratory Failure Mechanical Ventilation Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ICU, Fondazione Policlinico A. Gemelli IRCCS

Rome, 00198, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Tracheostomy
  • Plan to receive weaning from mechanical ventilation after more than 48 hours of mechanical ventilation
  • Hypoxemia (PaO2/FiO2<300) while on mechanical ventilation

Exclusion criteria

  • anticipated need for long-term mechanical ventilation
  • scheduled reconnections to mechanical ventilation
  • neuromuscular disease
  • chronic ventilator dependence
  • planned nocturnal home ventilation

Treatment and study plan

Oxygen therapy

Other

Oxygen supplementation delivered to the patient after disconnection from mechanical ventilation.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Succesful weaning - Day 28

    Time frame: Day 28 after randomization

    • Proportion of patient successfully weaned from mechanical ventilation on day 28 after randomization

  2. Time to successful weaning from mechanical ventilation

    Time frame: 90 days

    Weaning from mechanical ventilation and not reconnected up to hospital discharge-alive at 90 days.

  3. Number of reconnections required to the ventilator

    Time frame: 90 days

    Number of reconnections required to the ventilator before achieving succesful weaning.

  4. Mechanical ventilation-free days

    Time frame: Day 28, 60 and 90

    Days free of mechanical ventilation

  5. Intensive care unit-free days

    Time frame: Day 28, 60 and 90

    Days in which the patient is not in the Intensive care unit

  6. In-intensive care unit mortality

    Time frame: 90 days

    Mortality in the intensive care unit

  7. In-hospital care unit mortality

    Time frame: 90 days

    Mortality at hospital discharge

  8. 90-day mortality

    Time frame: 90 days

    mortality at 90 days

  9. Pneumonia

    Time frame: 90 days

    Rate of hospital-acquired pneumonia

  10. Shock

    Time frame: 90 days

    Rate of shock

  11. Time to decannulation

    Time frame: 90 days

    Time to successful decannulation of tracheostomy cannula

Study contacts

Contact information is provided by the study sponsor or research team.

Domenico Luca Grieco, MD

CONTACT

[email protected]

+393397681623

Tommaso Rosà, MD

CONTACT

[email protected]

+393401427210

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Tracheal High-flow vs. Conventional Oxygen for Weaning From Mechanical Ventilation in Tracheostomized Patients: an Open-label, Multicentre, Randomized Trial

Acronym: TRACFLOW

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jul 20, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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