Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2025-12-24 @ 5:57 PM
NCT ID:
NCT05853068
Brief Summary:
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
Detailed Description:
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.
Study:
NCT05853068
Study Brief:
Protocol Section:
NCT05853068