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

ARDS, Human Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05524558
• Other study ID #: 2022-A00058-35
• Status: Recruiting
• Start date: February 1, 2022
• Est. completion date: November 2022

Study information

• Verified date: August 2022
• Source: Bicetre Hospital
• Contact: Xavier Monnet, Pr
• Phone: 01 45 21 35 39
• Email: xavier.monnet[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

During acute respiratory distress syndrome (ARDS) the application of positive end-expiratory pressure (PEEP) prevents expiratory alveolar collapse. However, it can induce a predominant recruitment effect or, on the contrary, alveolar overdistension. The recruitment/overdistension ratio can be easily assessed using R/I ratio (or recruitment-to-inflation ratio). However, PEEP is likely to lower cardiac output and contribute to the cardiovascular failure that often occurs in patients with ARDS. Among its hemodynamic effects, PEEP is likely to increase pulmonary vascular resistance and, thus, right ventricular afterload. In theory, this effect should only occur if PEEP over-distends the lung volume, compressing the "extra-alveolar" vessels and increasing their resistance. However, this different effect of PEEP on pulmonary vascular resistance depending on the degree of recruitment or overdistension has never been demonstrated during ARDS in humans.

We retrospectively studied data collected from patients with ARDS, monitored by pulmonary artery catheter (PAC), to eventually find a correlation between the high PEEP-induced PVR increase and recruitement/overdistension profile.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: November 2022
• Est. primary completion date: September 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ARDS diagnosed

• Invasive mechanical ventilation

• Pulmonary artery catheter already in place

• Esophagal pressure measure

Exclusion Criteria:

• Pregnancy

• Prone position at inclusion

• Legal protection measures

Related Conditions & MeSH terms

• ARDS, Human
• Respiratory Distress Syndrome
• Ventilation Therapy; Complications

Intervention

Device:
• Pulmonary artery catheter
PAC already in place
• Esophagal pressure
Esophagal pressure already in place

Locations

Country	Name	City	State
France	Bicetre Hospital	Le Kremlin-Bicêtre	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Bicetre Hospital

Country where clinical trial is conducted

France, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Relationship between the R/I ratio and blood gas analysis	Data collected from the daily blood samples, to assess a relationship between R/I and arterial oxygen pressure	Up to hospital discharge (maximum : day 60)
Secondary	Relationship between the R/I ratio and respiratory system compliance	Ventilatory parameters collected at two levels of PEEP and R/I collected every day to assess a correlation between R/I and lung compliance	Up to hospital discharge (maximum : day 60)
Secondary	Relationship between right ventricle size and R/I ratio	Echocardiographic data collected at two levels of PEEP and R/I collected every day to assess a relationship between R/I and changes in RV surface.	Up to hospital discharge (maximum : day 60)
Secondary	Relationship between PVR change and Transpulmonary gradient (TPG) according to R/I	Data collected from PAC and R/I measure every day to assess the relationship between R/I and TPG at two levels of PEEP.	Up to hospital discharge (maximum : day 60)