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Not yet recruiting NCT07714564

Trcheal High-flow for Weaning From Mechanical Ventilation

No phase Interventional Tracheostomy Mechanical Ventilation Hypoxemic Respiratory Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Oxygen therapy.
Who it may be relevant to
Registry conditions: Tracheostomy, Mechanical Ventilation, Hypoxemic Respiratory Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Succesful weaning [Time frame: Day 7 after randomization]
Secondary outcome measures (11)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Italy · 1 center
  • ICU, Fondazione Policlinico A. Gemelli IRCCS — Rome

Identifiers

NCT: NCT07714564 · 27442

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗