A Phase 3 interventional study of High Flow Conditioned Oxygen Therapy in High Risk Patients and Non-invasive mechanical ventilation in Post-extubation Respiratory Failure, sponsored by Hospital Infanta Sofia. Completed at 2 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-09-12.
Sponsored by Hospital Infanta Sofia · Phase 3, Interventional, and Treatment
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.
Hospital Infanta Sofia is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
>65 years
inability to manage respiratory secretions
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: High Flow Conditioned Oxygen Therapy in High Risk Patients
Device: Non-invasive mechanical ventilation
Device: High Flow Conditioned Oxygen Therapy in High Risk Patients
Device: Conventional Oxygen Therapy
OptiFlow system (R) with nasal cannula.
Bilevel pressure support through a facial mask
Conventional Oxygen Therapy with nasal cannula or Venturi facial mask.
Post-extubation respiratory failure and Reintubation rate
Time frame: 3 months
Intensive Care Unit mortality rate
Time frame: 3 month
Hospital mortality rate
Time frame: 6 months
Intensive Care Unit length of stay
Time frame: 3 months
Hospital length of stay
Time frame: 6 months
Nosocomial pneumonia rate
Time frame: 3 months
Tracheobronchitis rate
Time frame: 3 months
This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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Hospital Infanta Sofia