Prono Position and Mechanical Power

Completed

• Conditions: Acute Respiratory Distress Syndrome

• Registration Number: NCT04369105
• Lead Sponsor: Sanatorio Anchorena San Martin

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.

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.

Study Timeline

• Study First Submitted: 2020-04-24
• Study First Submitted QC: 2020-04-29
• Study First Posted: 2020-04-30
• Study Start: 2020-05-01
• Status Verified: 2021-09
• Primary Completion: 2021-09-28
• Study Completion: 2021-09-28
• Last Update Submitted: 2021-09-28
• Last Update Posted: 2021-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Patients aged older than 18 years old under invasive mechanical ventilation with diagnostic criteria of acute respiratory distress syndrome acording to berlin definition and neccesity of prone positioning.

Exclusion Criteria

• Need to interrump prone positioning maneuver.
• Inability to collect data for any reason.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mechanical power of the respiratory system measured in supine compared with prone position while maintaining the same ventilatory setting	1) Supine position; 2) Prone position, after 15 min	Mechanical power measured in Joules/min

Secondary Outcome Measures

Name	Time	Method
Mechanical power of the respiratory system measured in supine compared with prone position after adjusting the ventilatory setting	1) Supine position; 2) Prone position, after 15 min of adjusting ventilatory setting.	Mechanical power measured in Joules/min

Trial Locations

Locations (1)

Sanatorio Anchorena de San Martin; 🇦🇷 San Martín, Buenos Aires, Argentina