Maneuver for Evaluating the Potential Recruitability of the Pulmonary Parenchyme in Patients With ARDS

NCT04387669 | Unknown

• 1 other identifier: 20-058
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This study will try to define the threshold of the recruitable volume (Vrec), obtained by a derecruitment maneuver, that permit to identify patients responder or not to alveolar recruitment maneuvers.

Conditions

Acute Respiratory Distress Syndrome

Keywords

Mechanical ventilation; Recruitment maneuvers; PEEP; Respiratory mechanics; End-expiratory lung volume; Recruitability; Respiratory Distress Syndrome; Oxygenation; PaO2/FiO2 ratio; Recruitable volume; Derecruitment

Outcome Measures

Primary Outcomes (1)

• Vrecruitable threshold (Vrec)

  The threshold of Vrec that permits to identify responders to alveolar recruitment maneuvers defined by an improvement of the PaO2/FiO2 ratio \> 20% 15 minutes after ARM, through ROC curve and Youden index.

  baseline

Secondary Outcomes (4)

• Evaluate the differences between responders and non responders to ARM concerning the following endpoints :

  28 days

• Evaluate the differences between responders and non responders to ARM concerning the following endpoints :

  28 days

• Calculate the mean time of realization of the MERP+ARM maneuvers

  15-20 minutes

• Number of patients presenting adverse events of ARM :

  15-20 minutes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Moderate to severe ARDS patients as per the Berlin definition

You may qualify if:

• Moderate to severe ARDS as per the Berlin definition (Partial pressure of oxygen (PaO2)/Fraction of inspired oxygen (FiO2) \< 200 mmHg) and within 72h of onset, with a FiO2 \> 60%
• Receiving assist/control mechanical ventilation with continuous sedation and neuromuscular blocker
• In supine position during the procedures and measurements
• Patients \> 18 years of age

You may not qualify if:

• Patients \< 18 years of age
• Pregnant woman
• Patient deprived of freedom or under a legal protective measure
• Hemodynamic instability defined as a mean arterial pressure \< 65 mmHg or increasing doses of vasopressor drugs
• Pneumothorax, pneumomediastinum, pleural fistula, sub-cutaneous emphysema
• Chronic or recent severe cardiac dysfunction

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Centre Hospitalier Universitaire - CHU Caen

Caen, 14000, France

RECRUITING

Related Publications (5)

• Chen L, Brochard L. Lung volume assessment in acute respiratory distress syndrome. Curr Opin Crit Care. 2015 Jun;21(3):259-64. doi: 10.1097/MCC.0000000000000193.

  PMID: 25827584 BACKGROUND

• Hess DR. Recruitment Maneuvers and PEEP Titration. Respir Care. 2015 Nov;60(11):1688-704. doi: 10.4187/respcare.04409.

  PMID: 26493593 BACKGROUND

• Writing Group for the Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART) Investigators; Cavalcanti AB, Suzumura EA, Laranjeira LN, Paisani DM, Damiani LP, Guimaraes HP, Romano ER, Regenga MM, Taniguchi LNT, Teixeira C, Pinheiro de Oliveira R, Machado FR, Diaz-Quijano FA, Filho MSA, Maia IS, Caser EB, Filho WO, Borges MC, Martins PA, Matsui M, Ospina-Tascon GA, Giancursi TS, Giraldo-Ramirez ND, Vieira SRR, Assef MDGPL, Hasan MS, Szczeklik W, Rios F, Amato MBP, Berwanger O, Ribeiro de Carvalho CR. Effect of Lung Recruitment and Titrated Positive End-Expiratory Pressure (PEEP) vs Low PEEP on Mortality in Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2017 Oct 10;318(14):1335-1345. doi: 10.1001/jama.2017.14171.

  PMID: 28973363 BACKGROUND

• Chen L, Chen GQ, Shore K, Shklar O, Martins C, Devenyi B, Lindsay P, McPhail H, Lanys A, Soliman I, Tuma M, Kim M, Porretta K, Greco P, Every H, Hayes C, Baker A, Friedrich JO, Brochard L. Implementing a bedside assessment of respiratory mechanics in patients with acute respiratory distress syndrome. Crit Care. 2017 Apr 4;21(1):84. doi: 10.1186/s13054-017-1671-8.

  PMID: 28372575 BACKGROUND

• Chen L, Del Sorbo L, Grieco DL, Junhasavasdikul D, Rittayamai N, Soliman I, Sklar MC, Rauseo M, Ferguson ND, Fan E, Richard JM, Brochard L. Potential for Lung Recruitment Estimated by the Recruitment-to-Inflation Ratio in Acute Respiratory Distress Syndrome. A Clinical Trial. Am J Respir Crit Care Med. 2020 Jan 15;201(2):178-187. doi: 10.1164/rccm.201902-0334OC.

  PMID: 31577153 BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Central Study Contacts

Emilien PUGLIESI, MD

CONTACT

+33 0686127482; pugliesi-e@chu-caen.fr

Jean-Luc Hanouz, MD, PhD

CONTACT

hanouz-jl@chu-caen.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: May 14, 2020
• Study Start: April 12, 2020
• Primary Completion: October 20, 2021
• Study Completion: December 31, 2021
• Last Updated: May 14, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)