Prono Position and Mechanical Power

Acute Respiratory Distress Syndrome Clinical Trial

— PROMP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04369105
• Other study ID #: 11/2020
• Status: Completed
• Start date: May 1, 2020
• Est. completion date: September 28, 2021

Study information

• Verified date: September 2021
• Source: Sanatorio Anchorena San Martin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 28, 2021
• Est. primary completion date: September 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

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

Locations

Country	Name	City	State
Argentina	Sanatorio Anchorena de San Martin	San Martín	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Sanatorio Anchorena San Martin

Country where clinical trial is conducted

Argentina, 

References & Publications (7)

Acute Respiratory Distress Syndrome Network, Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress sy — View Citation

Amato MB, Meade MO, Slutsky AS, Brochard L, Costa EL, Schoenfeld DA, Stewart TE, Briel M, Talmor D, Mercat A, Richard JC, Carvalho CR, Brower RG. Driving pressure and survival in the acute respiratory distress syndrome. N Engl J Med. 2015 Feb 19;372(8):74 — View 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: — View Citation

Guérin 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, Girar — View Citation

Marti J, Hall P, Hamilton P, Lamb S, McCabe C, Lall R, Darbyshire J, Young D, Hulme C. One-year resource utilisation, costs and quality of life in patients with acute respiratory distress syndrome (ARDS): secondary analysis of a randomised controlled tria — View Citation

Meade MO, Cook DJ, Guyatt GH, Slutsky AS, Arabi YM, Cooper DJ, Davies AR, Hand LE, Zhou Q, Thabane L, Austin P, Lapinsky S, Baxter A, Russell J, Skrobik Y, Ronco JJ, Stewart TE; Lung Open Ventilation Study Investigators. Ventilation strategy using low tid — View 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 ventilati — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mechanical power of the respiratory system measured in supine compared with prone position while maintaining the same ventilatory setting	Mechanical power measured in Joules/min	1) Supine position; 2) Prone position, after 15 min
Secondary	Mechanical power of the respiratory system measured in supine compared with prone position after adjusting the ventilatory setting	Mechanical power measured in Joules/min	1) Supine position; 2) Prone position, after 15 min of adjusting ventilatory setting.