Extubation Failure
Conditions
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 patients and in high-risk patients.
Interventions
DEVICEPreventive Conditioned NIV Therapy after planned extubation
Conditioned NIV during 48 hours following extubation.
DEVICEPreventive HFOT after planned extubation
HFOT set according to patients tolerance during 48 hours following extubation
Sponsors
Hospital Virgen de la Salud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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. 2. 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 criteria
* \<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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reintubation rate | 7 days |
Secondary
| Measure | Time frame |
|---|---|
| Intensive Care Unit mortality rate | 3 months |
| Hospital mortality rate | 3 months |
| Intensive Care Unit length of stay | 3 months |
| Hospital length of stay | 6 months |
| Respiratory infection rate | 6 months |
Countries
Spain
Outcome results
None listed