Trcheal High-flow for Weaning From Mechanical Ventilation

N/ANot Yet RecruitingNCT07714564

Fondazione Policlinico Universitario Agostino Gemelli IRCCS500 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

500

Conditions

Tracheostomy Mechanical Ventilation Hypoxemic Respiratory Failure

Interventions

Oxygen therapyOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

ICU, Fondazione Policlinico A. Gemelli IRCCS

Rome, Italy

Outcomes

Primary Outcomes

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

Succesful weaning - Day 28

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

Time frame: 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.

Time frame: 90 days

Number of reconnections required to the ventilator

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

Time frame: 90 days

Mechanical ventilation-free days

Days free of mechanical ventilation

Time frame: Day 28, 60 and 90

Intensive care unit-free days

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

Time frame: Day 28, 60 and 90

In-intensive care unit mortality

Mortality in the intensive care unit

Time frame: 90 days

In-hospital care unit mortality

Central Contacts

Domenico Luca Grieco, MD

CONTACT

+393397681623 domenicoluca.grieco@unicatt.it

Tommaso Rosà, MD

CONTACT

+393401427210 tommasoros22@gmail.com

Data from ClinicalTrials.gov

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