Clinical trial NCT04369105: Prono Position and Mechanical Power
Official title: Influence of the Prone Position on Mechanical Power Applied to Respiratory System: Multi-centric Descriptive Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Distress Syndrome
Keywords: ventilation, artificial
respiratory distress syndrome, adult
prone position
monitoring, physiologic
Lead sponsor: Sanatorio Anchorena San Martin
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Mechanical power of the respiratory system measured in supine compared with prone position while maintaining the same ventilatory setting
timeFrame: 1) Supine position; 2) Prone position, after 15 min
Secondary outcomes:
measure: Mechanical power of the respiratory system measured in supine compared with prone position after adjusting the ventilatory setting
timeFrame: 1) Supine position; 2) Prone position, after 15 min of adjusting ventilatory setting.
Other outcomes:
Locations:
city: San Martín
country: Argentina
facility: Sanatorio Anchorena de San Martin
state: Buenos Aires
Study officials:
References:
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citation: Serpa Neto A, Deliberato RO, Johnson AEW, Bos LD, Amorim P, Pereira SM, Cazati DC, Cordioli RL, Correa TD, Pollard TJ, Schettino GPP, Timenetsky KT, Celi LA, Pelosi P, Gama de Abreu M, Schultz MJ; PROVE Network Investigators. Mechanical power of ventilation is associated with mortality in critically ill patients: an analysis of patients in two observational cohorts. Intensive Care Med. 2018 Nov;44(11):1914-1922. doi: 10.1007/s00134-018-5375-6. Epub 2018 Oct 5.
citation: Gattinoni L, Tonetti T, Cressoni M, Cadringher P, Herrmann P, Moerer O, Protti A, Gotti M, Chiurazzi C, Carlesso E, Chiumello D, Quintel M. Ventilator-related causes of lung injury: the mechanical power. Intensive Care Med. 2016 Oct;42(10):1567-1575. doi: 10.1007/s00134-016-4505-2. Epub 2016 Sep 12.
citation: Guerin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20.