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OpenTrials
Completed

NCT Number: NCT04369105

Prono Position and Mechanical Power

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.

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Key information

Conditions

Acute Respiratory Distress Syndrome Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sanatorio Anchorena de San Martin

San Martín, Buenos Aires, B1650CQU, Argentina

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prone position

Other

The patients will be put in prone position while receiving invasive mechanical ventilation and the investigators will monitor changes in mechanical power applied to the respiratory system and compare with supine position

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Sanatorio Anchorena San Martin

Other

Registry information

Official study title

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

Acronym: PROMP

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 30, 2020
Registry last updated
Sep 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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