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Slow recruitment, interim analysis
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Failure of extubation after mechanical ventilation is a frequent and deleterious issue. Main reasons for failure are hypoxemia, secretions retention, lung collapse and excessive work of breathing. Most of this issues can be partly counterbalanced by a device named "High flow conditioned oxygen therapy (HFCO)". Then, our hypothesis is that HFCO may reduce the incidence of respiratory failure after extubation in patients with high risk for failure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Flow Conditioned Oxygen Therapy | Experimental | Intervention: The Optiflow(R) device supplies oxygen in controlled concentrations and at high flow (from 10 to 70 liters/min) through special nasal cannulae. The device also humidifies the gases mixtures up to 100% relative humidity. |
|
| Standard Oxygen Therapy | Active Comparator | The standard way of oxygen supply after extubation is either by nasal cannulae at flow between 1 and 5 liters/min or by mask with controlled oxygen concentration from 24% to 50%. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optiflow (Fisher&Paykel) | Device | The described method of oxygen supply will be maintained continuously for the first 24 hours after extubation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory failure after extubation | Severe hypoxemia (PaO2/Fraction of inspired O2 < 200), hypercapnia (PaCO2 > 50), respiratory acidosis (arterial pH < 7.30), severe tachypnea (>40x') | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rafael Fernandez, MD | Fundacio Althaia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICU. Fundacio Althaia | Manresa | Barcelona | 08242 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28466461 | Derived | Fernandez R, Subira C, Frutos-Vivar F, Rialp G, Laborda C, Masclans JR, Lesmes A, Panadero L, Hernandez G. High-flow nasal cannula to prevent postextubation respiratory failure in high-risk non-hypercapnic patients: a randomized multicenter trial. Ann Intensive Care. 2017 Dec;7(1):47. doi: 10.1186/s13613-017-0270-9. Epub 2017 May 2. |
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|
| Nasal cannulae or controlled oxygen concentration mask | Device | The described method of oxygen supply will be maintained continuously for the first 24 hours after extubation. |
|
|
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000072601 | Cannula |
| ID | Term |
|---|---|
| D057785 | Catheters |
| D004864 | Equipment and Supplies |
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