Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05408442 |
| Other study ID # |
210309002 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2021 |
| Est. completion date |
December 31, 2022 |
Study information
| Verified date |
June 2022 |
| Source |
Pontificia Universidad Catolica de Chile |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
The relationship between the presence or absence of endothelial dysfunction and changes in
pulmonary perfusion will be evaluated, to then determine if there is any association between
changes in the V / Q ratio and tolerance to the supine position after a prone cycle in
patients with acute respiratory distress syndrome on mechanical ventilation.
Description:
The prone position is a strategy used in patients with respiratory failure in order to
improve oxygenation, it has proven to be very effective compared to the supine position,
reducing mortality in critically ill patients diagnosed with acute respiratory distress
syndrome. Physiologically, these clinical findings could be explained by an improvement in
the ventilation/perfusion ratio (V/Q). Animal studies have shown that the prone position
significantly decreases the collapse of the dorsal regions of the lung, the one that
anatomically receives the highest percentage of blood flow. Nevertheless, to this day the
physiology behind these benefits in critically ill patients has not been studied, and without
this, the indications for use or duration of the maneuver has not yet been determined.
For many intensivists, determining the best time to re-supinate the patient is one of the
greatest challenges they face in clinical practice, since intolerance to supine position and
the need for a new prone cycle has been associated to the risk of complications, such as
accidental extubation, hemodynamic instability and intensive care unit (ICU) acquired
weakness. For this reason, it is relevant to determine what factors are associated with
tolerance to supine position, and knowing the presence of vascular defects due to endothelial
dysfunction during conventional and COVID-19 ARDS, our hypothesis is that patients who do not
tolerate the change to supine position after a prone cycle are unable to maintain an optimal
V/Q ratio, this due to the loss of regulation of the hypoxic pulmonary vasoconstriction
phenomenon related to endothelial dysfunction markers.
For this observational cohort clinical study, patients admitted to the intensive care unit of
the UC-CHRISTUS Clinical Hospital with diagnosis of ARDS will be evaluated. After inclusion
and the signing of the informed consent, physiological data of the patients will be recorded.
In addition, an evaluation of vascular function will be performed through ultrasound, near
infrared spectroscopy, and markers of endothelial damage in plasma. After baseline
measurements, the distribution of pulmonary ventilation and perfusion through EIT, pulmonary
function, hemodynamic, ventilatory and arterial gases will be evaluated. These measurements
will be taken again 1 hour before to position change, and 1, 8, 12 and 24 hours after the
change to supine position.
With this study we hope to be able to find a pattern associated to endothelial function and
perfusion in these patients that allows us to determine which patient can be repositioned
supine, without the need for a new prone cycle. With this information, an evaluation and
management protocol could be developed at long term for patients subjected to prone position,
which allows less time in mechanical ventilation and a reduction of the complications and
risks associated with the maneuver and with the ICU length of stay that directly affects the
quality of life of these patients in the short and long term.
