Hypoxemic Respiratory Failure, Mechanical Ventilation, Tracheostomy
Conditions
Brief 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.
Interventions
OTHEROxygen therapy
Oxygen supplementation delivered to the patient after disconnection from mechanical ventilation.
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Succesful weaning | 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
| Measure | Time frame | Description |
|---|---|---|
| Succesful weaning - Day 28 | Day 28 after randomization | 1\. Proportion of patient successfully weaned from mechanical ventilation on day 28 after randomization |
| Time to successful weaning from mechanical ventilation | 90 days | Weaning from mechanical ventilation and not reconnected up to hospital discharge-alive at 90 days. |
| Number of reconnections required to the ventilator | 90 days | Number of reconnections required to the ventilator before achieving succesful weaning. |
| Mechanical ventilation-free days | Day 28, 60 and 90 | Days free of mechanical ventilation |
| Intensive care unit-free days | Day 28, 60 and 90 | Days in which the patient is not in the Intensive care unit |
| In-intensive care unit mortality | 90 days | Mortality in the intensive care unit |
| In-hospital care unit mortality | 90 days | Mortality at hospital discharge |
| 90-day mortality | 90 days | mortality at 90 days |
| Pneumonia | 90 days | Rate of hospital-acquired pneumonia |
| Shock | 90 days | Rate of shock |
| Time to decannulation | 90 days | Time to successful decannulation of tracheostomy cannula |
Countries
Italy
Contacts
CONTACTDomenico Luca Grieco, MD
CONTACTTommaso Rosà, MD
PRINCIPAL_INVESTIGATORDomenico Luca Grieco
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Outcome results
None listed