Prono Position and Mechanical Power

NCT04369105 | Completed

• 1 other identifier: 11/2020
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Distress Syndrome

Keywords

ventilation, artificial; respiratory distress syndrome, adult; prone position; monitoring, physiologic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Mechanical power of the respiratory system measured in supine compared with prone position after adjusting the ventilatory setting

  1) Supine position; 2) Prone position, after 15 min of adjusting ventilatory setting.

Interventions

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Need to interrump prone positioning maneuver.
• Inability to collect data for any reason.

Sponsors & Collaborators

• Sanatorio Anchorena San Martin: lead

Study Sites (1)

Sanatorio Anchorena de San Martin

San Martín, Buenos Aires, B1650CQU, Argentina

Location

Related Publications (7)

• 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 trial. J Intensive Care. 2016 Aug 11;4:56. doi: 10.1186/s40560-016-0178-8. eCollection 2016.

  PMID: 27525106 RESULT

• 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 tidal volumes, recruitment maneuvers, and high positive end-expiratory pressure for acute lung injury and acute respiratory distress syndrome: a randomized controlled trial. JAMA. 2008 Feb 13;299(6):637-45. doi: 10.1001/jama.299.6.637.

  PMID: 18270352 RESULT

• 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 syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.

  PMID: 10793162 RESULT

• 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):747-55. doi: 10.1056/NEJMsa1410639.

  PMID: 25693014 RESULT

• 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.

  PMID: 30291378 RESULT

• 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.

  PMID: 27620287 RESULT

• 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.

  PMID: 23688302 RESULT

MeSH Terms

Conditions

Respiratory Distress Syndrome; Respiratory Aspiration

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of respiratory therapists

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: April 30, 2020
• Study Start: May 1, 2020
• Primary Completion: September 28, 2021
• Study Completion: September 28, 2021
• Last Updated: September 30, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)