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Prono Position and Mechanical Power (PROMP)

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ClinicalTrials.gov Identifier: NCT04369105
Recruitment Status : Recruiting
First Posted : April 30, 2020
Last Update Posted : August 26, 2020
Sponsor:
Information provided by (Responsible Party):
Matias Accoce, 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.


Condition or disease Intervention/treatment
Acute Respiratory Distress Syndrome Other: Prone position

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.

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Study Type : Observational
Estimated Enrollment : 20 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
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : November 30, 2020



Intervention Details:
  • Other: Prone position
    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 Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04369105


Contacts
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Contact: matias accoce, Physiotherapy +540221155438974 matiasaccoce@gmail.com
Contact: Joaquin Pérez, Physiotherapy +542245505907 licjoaquinperez@hotmail.com

Locations
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Argentina
Sanatorio Anchorena de San Martin Recruiting
San Martín, Buenos Aires, Argentina, B1650CQU
Contact: Matias Accoce, PT    +542215438954    matiasaccoce@gmail.com   
Contact: Joaquin Pérez, PT    +542245505907    licjoaquinperez@hotmail.com   
Sponsors and Collaborators
Sanatorio Anchorena San Martin
Publications of Results:

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Responsible Party: Matias Accoce, Head of respiratory therapists, Sanatorio Anchorena San Martin
ClinicalTrials.gov Identifier: NCT04369105    
Other Study ID Numbers: 11/2020
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: August 26, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Matias Accoce, Sanatorio Anchorena San Martin:
ventilation, artificial
respiratory distress syndrome, adult
prone position
monitoring, physiologic
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury