Prono Position and Mechanical Power (PROMP)

September 28, 2021 updated by: Matias Accoce, Sanatorio Anchorena San Martin

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Buenos Aires
      • San Martín, Buenos Aires, Argentina, B1650CQU
        • Sanatorio Anchorena de San Martin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The patients included will be those who atend to the intensive care unit of medical centers located in Buenos Aires province, Argetina.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanatorio Anchorena San Martin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2020

Primary Completion (Actual)

September 28, 2021

Study Completion (Actual)

September 28, 2021

Study Registration Dates

First Submitted

April 24, 2020

First Submitted That Met QC Criteria

April 29, 2020

First Posted (Actual)

April 30, 2020

Study Record Updates

Last Update Posted (Actual)

September 30, 2021

Last Update Submitted That Met QC Criteria

September 28, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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