Status:
COMPLETED
Postextubation High-flow Therapy vs Noninvasive Ventilation in Obese or at High-risk Patients
Lead Sponsor:
Hospital Virgen de la Salud
Conditions:
Extubation Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The main aim is to demonstrate whether reintubation rate is lower with preventive conditioned noninvasive ventilation (NIV) rather than with High-flow oxygen therapy (HFOT) in obese intermediate-risk ...
Eligibility Criteria
Inclusion
- High-Risk Patients: Patients under mechanical ventilation for more than 24 hours considered at high risk according to the presence of more than 3 of the following risk factors:
- \>65 years.
- Cardiac failure as the primary indication of mechanical ventilation.
- Moderate to severe chronic obstructive pulmonary disease.
- APACHE II \>12 points the extubation day.
- Body mass index \>30.
- Inability to manage respiratory secretions.
- Not simple weaning.
- More than 1 comorbidity.
- More than 7 days under mechanical ventilation.
- Hypercapnia during the spontaneous breathing trial.
- Airway patency problems.
- Obese Intermediate Risk Patients: Patients under mechanical ventilation for more than 24 hours with a Body mass index \>30 and considered at intermediate risk according to the presence of less than 3 of the following risk factors:
- \>65 years.
- Cardiac failure as the primary indication of mechanical ventilation.
- Moderate to severe chronic obstructive pulmonary disease.
- APACHE II \>12 points the extubation day.
- Inability to manage respiratory secretions.
- Not simple weaning.
- More than 1 comorbidity.
- More than 7 days under mechanical ventilation.
- Airway patency problems.
Exclusion
- \<18 years.
- Thacheotomized patients.
- Contraindications for NIV (recent facial or cervical trauma/surgery, active gastro-intestinal bleeding, lack of cooperation).
- Unscheduled extubation.
- Do not reintubate orders.
- No informed consent.
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
326 Patients enrolled
Trial Details
Trial ID
NCT04125342
Start Date
June 1 2020
End Date
December 1 2021
Last Update
March 17 2022
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Virgen de la Salud
Toledo, Castille-La Mancha, Spain, 45007
2
La princesa University Hospital
Madrid, Spain, 28006