- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05524558
Assessment of the Hemodynamic Effects of PEEP According to Alveolar Recruitment During the ARDS
Study Overview
Status
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Xavier Monnet, Pr
- Phone Number: 01 45 21 35 39
- Email: xavier.monnet@aphp.fr
Study Locations
-
-
Ile-de-France
-
Le Kremlin-Bicêtre, Ile-de-France, France, 94270
- Recruiting
- Bicetre Hospital
-
Contact:
- Xavier Monnet, Pr
- Phone Number: 01 45 21 35 39
- Email: xavier.monnet@aphp.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between PVR and recruitment-to-inflation ratio
Time Frame: Up to hospital discharge (maximum : day 60)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relationship between the R/I ratio and blood gas analysis
Time Frame: Up to hospital discharge (maximum : day 60)
|
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)
|
Relationship between the R/I ratio and respiratory system compliance
Time Frame: Up to hospital discharge (maximum : day 60)
|
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)
|
Relationship between right ventricle size and R/I ratio
Time Frame: Up to hospital discharge (maximum : day 60)
|
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)
|
Relationship between PVR change and Transpulmonary gradient (TPG) according to R/I
Time Frame: Up to hospital discharge (maximum : day 60)
|
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)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-A00058-35
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on ARDS, Human
-
Bicetre HospitalUnknown
-
Biozeus Biopharmaceutical S.A.InCor Heart InstituteTerminatedPulmonary Disease | ARDS | ARDS, HumanBrazil
-
Implicit BioscienceNo longer availableCOVID | SARS-CoV2 | ARDS, Human | ArdsItaly
-
National University Health System, SingaporeActive, not recruiting
-
King Abdul Aziz Specialist HospitalCompleted
-
Southeast University, ChinaCompleted
-
Magni FedericoUnknown
-
Wolfson Medical CenterUnknown
Clinical Trials on Pulmonary artery catheter
-
Tufts Medical CenterRecruitingHeart Failure | Cardiogenic ShockUnited States
-
Vanderbilt UniversityEdwards LifesciencesCompletedCardiac Surgery | Thoracic Surgery | Heart Surgery | Heart Transplant
-
Norwegian University of Science and TechnologyCompleted
-
Peking Union Medical College HospitalUnknownSeptic Shock | Fluid Therapy | Hemodynamic InstabilityChina
-
National Heart, Lung, and Blood Institute (NHLBI)ARDSNetCompletedLung Diseases | Acute Respiratory Distress Syndrome
-
University of PittsburghNational Heart, Lung, and Blood Institute (NHLBI); Agency for Healthcare Research...CompletedLung Diseases | Acute Respiratory Distress Syndrome | Acute Lung Injury
-
Assiut UniversityNot yet recruitingCardiac Output, Low
-
Pusan National University Yangsan HospitalCompletedCoronary Artery DiseaseKorea, Republic of
-
Massachusetts General HospitalTerminatedMixed Venous Oxygen Saturation | Tissue OxygenationUnited States