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| Name | Class |
|---|---|
| Rush University Medical Center | OTHER |
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We designed this study to dtermine whether invasive mechanical ventilation (MV) would have an impact on the reclassification of patients with acute hypoxemic respiratory failure (AHRF) -treated previously with non-invasive respiratory support- into categories of severity (mild, moderate, and severe). Our hypothesis is that the assessment of PaO2/FiO2 ratio on PEEP greater or equal to 5 cmH2O after intubation, in patients labeled as mild/moderate/severe AHRF while on non-invasive respiratory support, would identify that a marked proportion of patients would change the degree of severity after a brief period of invasive MV
Current criteria for definition of the acute respiratory distress syndrome (AHRF) are inadequate for inclusion of patients into clinical trials due to: (i) the lack of standardization for measuring the oxygenation defect (as assessed by the PaO2/FiO2 ratio) and (ii) the inclusion of non-intubated patients into the mild category of severity. We questioned whether the PaO2/FiO2 (P/F) ratio calculated before endotracheal intubation in non-intubated patients who otherwise meet AHRF criteria, would still meet the severity threshold once patients are intubated.
We will examine at 24 after intubation and initiation of MV whether adult patients with AHRF remained in the same AHRF category of severity (mild, moderate, severe) or do not meet the PaO2/FiO2 criterion for AHRF. If our hypothesis is supported, it would suggest that stratification of patients labeled based on P/F ratio while treated with non-invasive respiratory support is of limited utility for testing specific therapies for AHRF in non-intubated patients.
This is a high quality screening, longitudinal, defined population, retrospective study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients on non-invasive ventilatory support to IMV | Patients with AHRF treated with non-invasive ventilatory support [for the purpose of this study we included High-flow nasal cannula (HFNC), continuous positive airway pressure (CPAP), and non-invasive ventilation (NIV)] who required endotracheal intubation and invasive mechical ventilation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mechanical ventilation | Device | Need for endotracheal intubation and invasive mechanical ventilation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the degree of lung severity | from severe/moderate to moderate/mild, from moderate/mild to mild after a brief period of invasive MV | 60 days |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with AHRF (defined as PaO2/FiO2 lower or equal to 300 mmHg and FiO2 greater or equal to 0.3, on non-invasive ventilatory support) prior to intubation.
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| Name | Affiliation | Role |
|---|---|---|
| Jesús Villar | Hospital Universitario D. Negrin | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States | ||
| Jesús Villar |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| ID | Term |
|---|---|
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012151 | Resuscitation |
| D004638 | Emergency Treatment |
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| Las Palmas de Gran Canaria |
| Las Palmas |
| 35003 |
| Spain |
| D012138 |
| Respiratory Therapy |