Ignite Creation Date:
2025-12-25 @ 3:15 AM
Ignite Modification Date:
2026-01-01 @ 1:06 AM
Study NCT ID:
NCT04369105
Status:
COMPLETED
Last Update Posted:
2021-09-30
First Post:
2020-04-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prono Position and Mechanical Power
Sponsor:
Sanatorio Anchorena San Martin
Organization:
Study Overview
Official Title:
Influence of the Prone Position on Mechanical Power Applied to Respiratory System: Multi-centric Descriptive Study
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROMP
Brief Summary:
The primary objective of the study is to compare the mechanical power applied to the respiratory system in patient with acute respiratory distress syndrome in supine positioning and after the implementation of prone positioning while mantaining the same ventilatory setting.
The secondary objetive of the study is to compare the mechanical power applied to the respiratory system in patient with acute respiratory distress syndrome in supine positioning and after the implementation of prone positioning and adjusting an individualized ventilatory setting.
The secondary objetive of the study is to compare the mechanical power applied to the respiratory system in patient with acute respiratory distress syndrome in supine positioning and after the implementation of prone positioning and adjusting an individualized ventilatory setting.
Detailed Description:
Data of mechanical power will be collected prospectively in three different times:
1. In supine positioning (T0).
2. After 15 minutes of having implemented prone positioning while maintaining the same ventilatory settings that in supine (T1).
3. In prone positioning after 15 min of having adjusted an individualized ventilatory setting (T2).
Besides, the investigators will take an arterial blood sample in T0 and T2 to calculate changes in oxygenation status and ventilatory ratio.
In case that esophageal manometry is available, the investigators will collect data regarding to transpulmonary and esophageal pressure in order to calculate the mechanical power applied to the lung parenchyma.
1. In supine positioning (T0).
2. After 15 minutes of having implemented prone positioning while maintaining the same ventilatory settings that in supine (T1).
3. In prone positioning after 15 min of having adjusted an individualized ventilatory setting (T2).
Besides, the investigators will take an arterial blood sample in T0 and T2 to calculate changes in oxygenation status and ventilatory ratio.
In case that esophageal manometry is available, the investigators will collect data regarding to transpulmonary and esophageal pressure in order to calculate the mechanical power applied to the lung parenchyma.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: