Non-Invasive Ventilation versus High Flow Oxygenotherapy in Patients at High Risk of Extubation Failure

Phase 4

Recruiting

Lead Sponsor: Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana

Brief Summary: The primary objective will be the reduction of extubation failure.

Recruitment & Eligibility

Inclusion Criteria

Age ≥ 65 years

Hypercapnia (paCO2 > 45 mmHg) at the time of extubation

Ineffective cough

Abundant secretions

Body mass index (BMI)>30

Chronic obstructive pulmonary disease (COPD) or asthma as a cause of invasive mechanical ventilation

Cardiac failure as a cause of intubation or history of ejection fraction <= 30%

Acute Physiology and Chronic Health Evaluation (APACHE II) > 12 at the time of extubation

Time of mechanical ventilation > 7 days

Positive water balance

Difficult or prolonged weaning

Pneumonia (or any medical pathology over surgical) as a cause of ARF

Exclusion Criteria

Structural neurologic disease

Direct extubation without performing a spontaneous breathing trial

Contraindication to apply NIV or high flow oxygen

Not intubation order

Life support therapy limitation

Tracheotomized

Spinal cord injury

Scheduled surgical intervention in the next 48 hours post-extubation

Re-admission

Transfer to another center

Refusal of the patient or relatives

Primary Outcome Measures

Name	Time	Method
Acute respiratory failure within 48 hours after extubation		Acute respiratory failure within 48 hours after extubation

Secondary Outcome Measures

Name	Time	Method
Intubation		Intubation
Nosocomial infection		Nosocomial infection
Tracheotomy		Tracheotomy
Organ failure		Organ failure
ICU Mortality		ICU Mortality
Hospital mortality		Hospital mortality
28-day mortality		28-day mortality
ICU length of stay		ICU length of stay
Hospital length of stay		Hospital length of stay
Duration of mechanical ventilation		Duration of mechanical ventilation

Locations (8): Hospital De Tortosa Verge De La Cinta
🇪🇸
Tortosa, Spain
Hospital De Manises
🇪🇸
Manises, Spain
Hospital Francesc De Borja De Gandía
🇪🇸
Gandia, Spain
Consorcio Hospitalario Provincial De Castellon
🇪🇸
Castello De La Plana, Spain
Hospital De Sagunto
🇪🇸
Sagunto, Spain
Hospital Arnau De Vilanova De Valencia
🇪🇸
Valencia, Spain
Hospital General Universitario De Castellon
🇪🇸
Castello De La Plana, Spain
Hospital Universitario Dr Peset Aleixandre
🇪🇸
Valencia, Spain
Hospital De Tortosa Verge De La Cinta
🇪🇸Tortosa, Spain
Pablo Concha Martínez
Site contact
977519100
pconcha.ebre.ics@gencat.cat