OXYGEN for Weaning failure | Weaning of mechanical ventilation

Inclusion criteria

• {"criterion_text":"- Age ≥ 65 years\n- Body mass index (BMI)>30\n- Chronic obstructive pulmonary disease (COPD) or asthma as a cause of invasive mechanical ventilation\n- Cardiac failure as a cause of intubation or history of ejection fraction <= 30%\n- Acute Physiology and Chronic Health Evaluation (APACHE II) > 12 at the time of extubation\n- Time of mechanical ventilation > 7 days\n- Positive water balance\n- Difficult or prolonged weaning\n- Pneumonia (or any medical pathology over surgical) as a cause of ARF\n- Hypercapnia (paCO2 > 45 mmHg) at the time of extubation\n- Ineffective cough\n- Abundant secretions"}

Exclusion criteria

• {"criterion_text":"- Structural neurologic disease\n- Not intubation order\n- Life support therapy limitation\n- Tracheotomized\n- Spinal cord injury\n- Scheduled surgical intervention in the next 48 hours post-extubation\n- Re-admission\n- Transfer to another center\n- Refusal of the patient or relatives\n- Direct extubation without performing a spontaneous breathing trial\n- Contraindication to apply NIV or high flow oxygen"}

Primary endpoints

• {"endpoint_text":"- Acute respiratory failure within 48 hours after extubation","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Intubation\n- Nosocomial infection\n- Tracheotomy\n- Organ failure\n- ICU Mortality\n- Hospital mortality\n- 28-day mortality\n- ICU length of stay\n- Hospital length of stay\n- Duration of mechanical ventilation","definition_or_measurement_approach":""}

Spain

Earliest CTIS Part Ii Submission Date

05-06-2024

Latest Decision Or Authorization Date

14-01-2025

Processing Time Days

223

Number Of Sites

8

Number Of Participants

260

Primary sponsor

Full Name

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

Organisation Type

Patient organisation/association

Country Of Registered Address

Spain

Third parties

• {"country":"","full_name":"Fundacion FISABIO","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"","full_name":"Hospital Universitario Doctor Peset","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"Spain","full_name":"AIR LIQUIDE SANTE INTERNATIONAL","duties_or_roles":"Product manufacturer / marketing authorisation holder for investigational product","organisation_type":""}