Assessment of the Hemodynamic Effects of PEEP According to Alveolar Recruitment During the ARDS

NCT05524558 | Unknown

• 1 other identifier: 2022-A00058-35
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The corner stone of the treatment of ARDS is mechanical ventilation with high levels of positive end-expiratory pressure, also called PEEP. A high level of PEEP is recommended and frequently used. But PEEP can lower cardiac output and contribute to circulatory failure during mechanical ventilation. Nevertheless, in theory, the PEEP-induced pulmonary vascular resistance (PVR) increase could depend on the level of alveolar recruitment, but it has never been proven. Thus, the aim of this study is to determine the relation between the high-PEEP induced PVR and the alveolar recruitment or overdistension.

Conditions

ARDS, Human; Ventilation Therapy; Complications; Alveolar; Disorder

Outcome Measures

Primary Outcomes (1)

• Correlation between PVR and recruitment-to-inflation ratio

  PVR collected at two levels of PEEP and the R/I ratio to assess a relationship between the two variables

  Up to hospital discharge (maximum : day 60)

Secondary Outcomes (4)

• Relationship between the R/I ratio and blood gas analysis

  Up to hospital discharge (maximum : day 60)

• Relationship between the R/I ratio and respiratory system compliance

  Up to hospital discharge (maximum : day 60)

• Relationship between right ventricle size and R/I ratio

  Up to hospital discharge (maximum : day 60)

• Relationship between PVR change and Transpulmonary gradient (TPG) according to R/I

  Up to hospital discharge (maximum : day 60)

Interventions

Pulmonary artery catheter DEVICE

PAC already in place

Esophagal pressure DEVICE

Esophagal pressure already in place

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Mechanically ventilated patients over the age of 18, exhibiting ARDS and with a PAC-monitoring already in place.

You may qualify if:

• ARDS diagnosed
• Invasive mechanical ventilation
• Pulmonary artery catheter already in place
• Esophagal pressure measure

You may not qualify if:

• Pregnancy
• Legal protection measures

Sponsors & Collaborators

• Bicetre Hospital: lead

Study Sites (1)

Bicetre Hospital

Le Kremlin-Bicêtre, Île-de-France Region, 94270, France

RECRUITING

Related Publications (9)

• Michard F, Chemla D, Richard C, Wysocki M, Pinsky MR, Lecarpentier Y, Teboul JL. Clinical use of respiratory changes in arterial pulse pressure to monitor the hemodynamic effects of PEEP. Am J Respir Crit Care Med. 1999 Mar;159(3):935-9. doi: 10.1164/ajrccm.159.3.9805077.

  PMID: 10051276 BACKGROUND

• GUYTON AC, LINDSEY AW, ABERNATHY B, RICHARDSON T. Venous return at various right atrial pressures and the normal venous return curve. Am J Physiol. 1957 Jun;189(3):609-15. doi: 10.1152/ajplegacy.1957.189.3.609. No abstract available.

  PMID: 13458395 BACKGROUND

• Goldberg HS, Rabson J. Control of cardiac output by systemic vessels. Circulatory adjustments to acute and chronic respiratory failure and the effect of therapeutic interventions. Am J Cardiol. 1981 Mar;47(3):696-702. doi: 10.1016/0002-9149(81)90557-9. No abstract available.

  PMID: 7008571 BACKGROUND

• Potkin RT, Hudson LD, Weaver LJ, Trobaugh G. Effect of positive end-expiratory pressure on right and left ventricular function in patients with the adult respiratory distress syndrome. Am Rev Respir Dis. 1987 Feb;135(2):307-11. doi: 10.1164/arrd.1987.135.2.307.

  PMID: 3544983 BACKGROUND

• WHITTENBERGER JL, McGREGOR M, BERGLUND E, BORST HG. Influence of state of inflation of the lung on pulmonary vascular resistance. J Appl Physiol. 1960 Sep;15:878-82. doi: 10.1152/jappl.1960.15.5.878. No abstract available.

  PMID: 13784949 BACKGROUND

• ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.

  PMID: 22797452 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

• Monnet X, Marik PE, Teboul JL. Prediction of fluid responsiveness: an update. Ann Intensive Care. 2016 Dec;6(1):111. doi: 10.1186/s13613-016-0216-7. Epub 2016 Nov 17.

  PMID: 27858374 BACKGROUND

• Cecconi M, De Backer D, Antonelli M, Beale R, Bakker J, Hofer C, Jaeschke R, Mebazaa A, Pinsky MR, Teboul JL, Vincent JL, Rhodes A. Consensus on circulatory shock and hemodynamic monitoring. Task force of the European Society of Intensive Care Medicine. Intensive Care Med. 2014 Dec;40(12):1795-815. doi: 10.1007/s00134-014-3525-z. Epub 2014 Nov 13.

  PMID: 25392034 BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Central Study Contacts

Xavier Monnet, Pr

CONTACT

01 45 21 35 39; xavier.monnet@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 1, 2022
• Study Start: February 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: November 1, 2022
• Last Updated: September 1, 2022

Record last verified: 2022-08

Locations

FR (1)