ARDS, HumanNCT05524558
Assessment of the Hemodynamic Effects of PEEP According to Alveolar Recruitment During the ARDS
An observational study of ARDS, Human and Ventilation Therapy; Complications, run by Bicetre Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS, Human, Ventilation Therapy; Complications, Alveolar; Disorder
- What is being tested?
- Pulmonary artery catheter and Esophagal pressure
- Type of treatment
- Medical device
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2022to Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Mechanically ventilated patients over the age of 18, exhibiting ARDS and with a PAC-monitoring already in place.
Who may be able to join
- ARDS diagnosed
- Invasive mechanical ventilation
- Pulmonary artery catheter already in place
- Esophagal pressure measure
Who cannot join
- Pregnancy
- Prone position at inclusion
- Legal protection measures
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Bicetre Hospital
Le Kremlin-Bicêtre, Île-de-France Region, 94270
Xavier Monnet, Pr, 01 45 21 35 39, xavier.monnet@aphp.fr
About this study
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.
Read the 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.
- Being tested
- Pulmonary artery catheter, Esophagal pressure
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary artery catheterDevice
PAC already in place
Esophagal pressureDevice
Esophagal pressure already in place
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to hospital discharge (maximum : day 60)
Secondary outcomes (4)
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
Measured: Up to hospital discharge (maximum : day 60)
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
Measured: Up to hospital discharge (maximum : day 60)
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.
Measured: Up to hospital discharge (maximum : day 60)
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.
Measured: Up to hospital discharge (maximum : day 60)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start1 Feb 2022
- Primary completionSep 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for ARDS, HumanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bicetre Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xavier Monnet, Bicetre Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05524558
- Sponsor's protocol ID
- 2022-A00058-35
- Status last verified
- Aug 2022
- First submitted
- 30 Aug 2022
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 10051276GUYTON 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.
PubMed 13458395Goldberg 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.
PubMed 7008571Potkin 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.
PubMed 3544983WHITTENBERGER 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.
PubMed 13784949ARDS 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.
PubMed 22797452Chen 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.
PubMed 31577153Monnet 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.
PubMed 27858374Cecconi 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.
PubMed 25392034
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Hemodynamic Effects of PEEP According to Alveolar Recruitment During the ARDS
- ClinicalTrials.gov ID
- NCT05524558
- Acronym / sponsor ID
- 2022-A00058-35
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Bicetre HospitalUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 1 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Mechanically ventilated patients over the age of 18, exhibiting ARDS and with a PAC-monitoring already in place.
Key inclusion criteria (4 listed)
- ARDS diagnosed
- Invasive mechanical ventilation
- Pulmonary artery catheter already in place
- Esophagal pressure measure
Key exclusion criteria (3 listed)
- Pregnancy
- Prone position at inclusion
- Legal protection measures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary artery catheterPAC already in place | Device | – |
| Esophagal pressureEsophagal pressure already in place | Device | – |
Primary outcome
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
4 secondary outcomes
Relationship between the R/I ratio and blood gas analysis
Time frame: 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)
Relationship between right ventricle size and R/I ratio
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
- Background: PubMed 10051276Michard 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.
- Background: PubMed 13458395GUYTON 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.
- Background: PubMed 7008571Goldberg 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.
- Background: PubMed 3544983Potkin 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.
- Background: PubMed 13784949WHITTENBERGER 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.
- Background: PubMed 22797452ARDS 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.
- Background: PubMed 31577153Chen 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.
- Background: PubMed 27858374Monnet 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.
- Background: PubMed 25392034Cecconi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ARDS, Human and Ventilation Therapy; Complications, run by Bicetre Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xavier Monnet, Pr (01 45 21 35 39, xavier.monnet@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between PVR and recruitment-to-inflation ratio (time frame: Up to hospital discharge (maximum : day 60)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05524558, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2022.