High-flow Conditioned Oxygen Therapy Versus Non-invasive Ventilation: Prevention of Post-extubation Failure

Hospital Infanta Sofia

Status and phase: Completed; Phase 3

Conditions: Post-extubation Respiratory Failure

Treatments: Device: Conventional Oxygen Therapy; Device: High Flow Conditioned Oxygen Therapy in High Risk Patients; Device: Non-invasive mechanical ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT01191489

HULP-3116

Details and patient eligibility

About

The main aim is to demonstrate whether the high flow conditioned oxygen therapy reduces the reintubation rate. Post-extubation respiratory failure risk will be stratified (as the randomization). In high risk patients high flow conditioned oxygen therapy will be compared with with not conditioned non-invasive mechanical ventilation. In low risk patients comparison will be conventional oxygen therapy. Hypercapnic patients will be excluded.

Enrollment: 1,042 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Low Risk Patients:

• Any extubated patients after tolerating a spontaneous breathing trial.

• High Risk Patients:

• Any extubated patients after >48 hours under mechanical ventilation and any of the following:

• >65 years

  • cardiac failure as the primary indication of mechanical ventilation

  • COPD

  • APACHE II >12 points the extubation day

  • BMI >30

  • inability to manage respiratory secretions

    • 1 failed spontaneous breathing trial
    • 1 comorbidity
    • 7 days under mechanical ventilation

Exclusion criteria

• <18 years
• thacheotomized patients
• recent facial or cervical trauma/surgery
• active gastro-intestinal bleeding
• lack of cooperation and patients with any failed spontaneous breathing trial because of hypercapnia development.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

1,042 participants in 4 patient groups

High Flow Conditioned Oxygen Therapy in high risk patients

Experimental group

Treatment:

Device: High Flow Conditioned Oxygen Therapy in High Risk Patients

Non-invasive mechanical ventilation in High Risk Patients

Active Comparator group

Treatment:

Device: Non-invasive mechanical ventilation

High Flow Conditioned Oxygen Therapy in Low Risk Patients

Experimental group

Treatment:

Device: High Flow Conditioned Oxygen Therapy in High Risk Patients

Conventional Oxygen Therapy in Low Risk Patients

Active Comparator group

Treatment:

Device: Conventional Oxygen Therapy