Acute Respiratory Distress SyndromeMERPNCT04387669
Maneuver for Evaluating the Potential Recruitability of the Pulmonary Parenchyme in Patients With ARDS
An observational study of Acute Respiratory Distress Syndrome, run by University Hospital, Caen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 12 Apr 2020to 31 Dec 2021
- How long will I take part?
- 1 Month
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Moderate to severe ARDS patients as per the Berlin definition
Who may be able to join
- 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
Who cannot join
- 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
- Patient with a PEEP > 15 cmH20 before inclusion
- Patient with no therapeutic perspective; candidate for palliative care exclusively or with end of life decision before inclusion
Trial locations and contacts
1 site in 1 country.
Jean-Luc Hanouz, MD, PhD contact
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire - CHU Caen
Caen, 14000
About this study
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.
Read the detailed description
Background:
Acute respiratory distress syndrome (ARDS) is characterized by a major loss of lung volume due to alveolar flooding, atelectasis and consolidation. Alveolar recruitment maneuvers (ARM) permit to recruit non-aerated or poorly aerated lung tissue, and thus may improve gas exchange and oxygenation in patients with ARDS. However, ARM may also be harmful by overdistending the previously open lung tissue and can induce hemodynamic instability. The potential effectiveness and benefit of ARM depends on the patient's recruitability. A simple, routinely applicable bedside method to assess recruitability has been described in 2020 and is as efficient as multiple pressure-volume curves. We called it MERP for Potential for lung Recruitability Evaluation Method.
The investigators therefore propose to use this new method that determine lung recruitability as a diagnostic test to determine responder an non responder to ARM, and define a threshold.
Objectives:
The major aim is to determine the threshold of Vrec with the best sensitivity and specificity to define patient responders to alveolar recruitment maneuvers in ARDS.
The secondary objectives are :
- Evaluate the differences in morbi-mortality comparing responders and non responders to ARM
- Calculate the mean time of realization of the MERP+ARM maneuvers
- Estimate the occurence of secondary effects due to ARM (hemodynamic instability, arrhythmia, hypoxemia)
Methods:
This study will enroll at least 42 patients from the three Intensive Care Units at CHU Caen Normandy in 18 months. In all patients a MERP will be performed to determine the recruitable volume (Vrec). It consists to a brutal drop in PEEP level from 15 cmH2O to 5 cmH2O over a single breath maneuver to determine the increased end expiratory volume at the next respiratory cycle. The difference between this volume and the tidal volume represent the " measured recruitable volume " (Vmes). We can therefore calculate the predicted change in lung volume (Vcalc) by the product of respiratory system compliance at low PEEP (5 cmH20) and the change in pressure (10 cmH2O). Finally, the Vrec for each patients is the difference between the Vmes and the Vcalc.
An alveolar recruitment maneuver is then performed following the maximal alveolar recruitment method (driving pressure of 15 cmH2O, with 3 steps of PEEP 20-25-30 cmH2O) followed by a decremental PEEP procedure to determine the best PEEP. 15 minutes a posteriori, a blood gas sample permits to calculate the change in PaO2/FiO2 ratio.
Data Analysis:
The primary endpoint is to determine 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.
- 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
- Medical subject headings
- Respiratory Distress Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Secondary outcomes (4)
Evaluate the differences between responders and non responders to ARM concerning the following endpoints :
- 28 days survival
- ICU survival
Measured: 28 days
Evaluate the differences between responders and non responders to ARM concerning the following endpoints :
- Free-days ventilation from day 1 to day 28
- Number of days with moderate to severe ARDS criteria of Berlin definition
- Length of ICU stay (Number of days)
- Length of hospital stay (Number of days)
- Number of days with neuromuscular blockers treatment
Measured: 28 days
Calculate the mean time of realization of the MERP+ARM maneuvers
Measured: 15-20 minutes
Number of patients presenting adverse events of ARM :
- Cardiopulmonary arrest or arrhythmia per-ARM : acute atrial fibrillation or flutter, ventricular tachycardia, Heart rate > 150 bpm or < 60 bpm
- Pneumothorax due to ARM
- Hemodynamic instability (mean blood pressure < 65mmHg or systolic blood pressure < 90mmHg) during> 30s, or the need to introduce or increase vasopressor drug
- Decrease of pulse oximetry (SpO2) < 85% for > 30 seconds
Measured: 15-20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start12 Apr 2020
- Primary completion20 Oct 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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
- 42 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04387669
- Sponsor's protocol ID
- 20-058
- Acronym
- MERP
- Status last verified
- Apr 2020
- First submitted
- 27 Apr 2020
- Last updated
- 14 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25827584Hess DR. Recruitment Maneuvers and PEEP Titration. Respir Care. 2015 Nov;60(11):1688-704. doi: 10.4187/respcare.04409.
PubMed 26493593Writing 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.
PubMed 28973363Chen 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.
PubMed 28372575Chen 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 31577153
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maneuver for Evaluating the Potential Recruitability of the Pulmonary Parenchyme in Patients With ARDS
- ClinicalTrials.gov ID
- NCT04387669
- Acronym / sponsor ID
- MERP / 20-058
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- Mechanical ventilation, Recruitment maneuvers, PEEP, Respiratory mechanics, End-expiratory lung volume, Recruitability, Respiratory Distress Syndrome, Oxygenation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 12 Apr 2020 (actual)
- Primary completion
- 20 Oct 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 14 May 2020 (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.
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.
Detailed description
Background:
Acute respiratory distress syndrome (ARDS) is characterized by a major loss of lung volume due to alveolar flooding, atelectasis and consolidation. Alveolar recruitment maneuvers (ARM) permit to recruit non-aerated or poorly aerated lung tissue, and thus may improve gas exchange and oxygenation in patients with ARDS. However, ARM may also be harmful by overdistending the previously open lung tissue and can induce hemodynamic instability. The potential effectiveness and benefit of ARM depends on the patient's recruitability. A simple, routinely applicable bedside method to assess recruitability has been described in 2020 and is as efficient as multiple pressure-volume curves. We called it MERP for Potential for lung Recruitability Evaluation Method.
The investigators therefore propose to use this new method that determine lung recruitability as a diagnostic test to determine responder an non responder to ARM, and define a threshold.
Objectives:
The major aim is to determine the threshold of Vrec with the best sensitivity and specificity to define patient responders to alveolar recruitment maneuvers in ARDS.
The secondary objectives are :
- Evaluate the differences in morbi-mortality comparing responders and non responders to ARM
- Calculate the mean time of realization of the MERP+ARM maneuvers
- Estimate the occurence of secondary effects due to ARM (hemodynamic instability, arrhythmia, hypoxemia)
Methods:
This study will enroll at least 42 patients from the three Intensive Care Units at CHU Caen Normandy in 18 months. In all patients a MERP will be performed to determine the recruitable volume (Vrec). It consists to a brutal drop in PEEP level from 15 cmH2O to 5 cmH2O over a single breath maneuver to determine the increased end expiratory volume at the next respiratory cycle. The difference between this volume and the tidal volume represent the " measured recruitable volume " (Vmes). We can therefore calculate the predicted change in lung volume (Vcalc) by the product of respiratory system compliance at low PEEP (5 cmH20) and the change in pressure (10 cmH2O). Finally, the Vrec for each patients is the difference between the Vmes and the Vcalc.
An alveolar recruitment maneuver is then performed following the maximal alveolar recruitment method (driving pressure of 15 cmH2O, with 3 steps of PEEP 20-25-30 cmH2O) followed by a decremental PEEP procedure to determine the best PEEP. 15 minutes a posteriori, a blood gas sample permits to calculate the change in PaO2/FiO2 ratio.
Data Analysis:
The primary endpoint is to determine 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Moderate to severe ARDS patients as per the Berlin definition
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Vrecruitable threshold (Vrec)
Time frame: baseline
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.
4 secondary outcomes
Evaluate the differences between responders and non responders to ARM concerning the following endpoints :
Time frame: 28 days
Evaluate the differences between responders and non responders to ARM concerning the following endpoints :
Time frame: 28 days
Calculate the mean time of realization of the MERP+ARM maneuvers
Time frame: 15-20 minutes
Number of patients presenting adverse events of ARM :
Time frame: 15-20 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2020.
- Background: PubMed 25827584Chen 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.
- Background: PubMed 26493593Hess DR. Recruitment Maneuvers and PEEP Titration. Respir Care. 2015 Nov;60(11):1688-704. doi: 10.4187/respcare.04409.
- Background: PubMed 28973363Writing 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.
- Background: PubMed 28372575Chen 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.
- 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.
- Individual participant dataSharing planned: No
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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.
Jean-Luc Hanouz, MD, PhD contact
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 Acute Respiratory Distress Syndrome, run by University Hospital, Caen 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 8 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 14 May 2020. 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 Emilien PUGLIESI, MD (+33 0686127482, pugliesi-e@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vrecruitable threshold (Vrec) (time frame: baseline). 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 NCT04387669, which also lists 5 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 14 May 2020.