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Trcheal High-flow for Weaning From Mechanical Ventilation

ConditionsTracheostomyMechanical VentilationHypoxemic Respiratory Failure
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Tracheostomy

Plan to receive weaning from mechanical ventilation after more than 48 hours of mechanical ventilation

Hypoxemia (PaO2/FiO2<300) while on mechanical ventilation

Disqualifiers

anticipated need for long-term mechanical ventilation

scheduled reconnections to mechanical ventilation

neuromuscular disease

chronic ventilator dependence

Trial design

Design model

Parallel

Treatments tested in this trial

  • Oxygen therapy

    Other intervention

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

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: High-flow oxygenExperimental treatment 1 intervention
Group B: Conventional oxygenActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Day 7 after randomization

Secondary outcomes

1

Succesful weaning - Day 28

1\. Proportion of patient successfully weaned from mechanical ventilation on day 28 after randomization

Time frame
Day 28 after randomization
2

Time to successful weaning from mechanical ventilation

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

Time frame
90 days
3

Number of reconnections required to the ventilator

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

Time frame
90 days
4

Mechanical ventilation-free days

Days free of mechanical ventilation

Time frame
Day 28, 60 and 90

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: