PROMP: Prono Position and Mechanical Power

Sponsor

Sanatorio Anchorena San Martin (Other)

Overall Status

Completed

CT.gov ID

NCT04369105

Collaborator

(none)

Enrollment

Location

16.9

Actual Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Distress Syndrome	Other: Prone position

Detailed Description

Data of mechanical power will be collected prospectively in three different times:

In supine positioning (T0).
After 15 minutes of having implemented prone positioning while maintaining the same ventilatory settings that in supine (T1).
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 Design

Study Type:

Observational

Actual Enrollment :

45 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Influence of the Prone Position on Mechanical Power Applied to Respiratory System: Multi-centric Descriptive Study

Actual Study Start Date :

May 1, 2020

Actual Primary Completion Date :

Sep 28, 2021

Actual Study Completion Date :

Sep 28, 2021

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.