Acute Respiratory Distress SyndromeTIPEX-VOLTEXNCT04352725
Effect of PEEP Titration on the EELV Measured by the Nitrogen Dilution Technique in ARDS
A study testing End-expiratory lung volume measurement and incremental PEEP titration in people with Acute Respiratory Distress Syndrome, run by Centre Hospitalier Intercommunal Aix-Pertuis at 1 site in France.
Trial summary
Mechanical ventilation of the patient with acute respiratory distress syndrome is one of the first therapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- End-expiratory lung volume measurement and incremental PEEP titration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jan 2020to 30 Nov 2020
- Phase
- Interventional
- 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
Who may be able to join
- Patients admitted to intensive care with a diagnosis of moderate to severe ARDS in accordance with the Berlin criteria, i.e. a PAFI <200 and PEEP >5cm H20 ratio
- Diagnosis of ARDS made within 72 hours
- Age over 18 years
- Informed consent of the patient and/or trusted person where applicable
Who cannot join
- Start of mechanical ventilation more than 72 hours prior to inclusion.
- SDRA evolving for more than 72 hours
- Presence of major hemodynamic instability with mean blood pressure <60mmhg, and/or heart rate <45 bpm or >150bpm with an increase in vasopressor amine dosage of more than 20% over the last 6 hours.
- Intracranial hypertension with CPP<60mmhg
- Massive hemoptysis requiring immediate surgical or interventional radiology procedure
- Tracheal surgery (except intensive care tracheotomy) or sternotomy within the previous 15 days
Show all 20Show fewer
- Trauma or surgery of the face in the previous 15 days.
- Deep vein thrombosis treated for less than 2 days
- Pacemaker implantation in the last 2 days
- Unstable fracture (spine, femur or pelvis)
- Respiratory reasons
- use of extracorporeal oxygenation
- nitric oxide
- pleural drainage system with bronchopleural gap
- pulmonary transplantation
- Poor respiratory tolerance per procedure with desaturation Spo2<85%.
- Poor hemodynamic tolerability per procedure combining hypotension with MAP<65mmhg and a 20% increase in norepinephrine dosage.
- Lack of patient consent to proceed
- minor patient
- lack of consent
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Intercommunal Aix-Pertuis
Aix-en-Provence, 13100
Agathe BOULANT, 0442335650 ext. +33, aboulant@live.fr
Thibault HELBERT, Dr.
About this study
Official title: Effect of Positive End Expiratory Pressure Titration on the End-expiratory Lung Volume Measured by the Nitrogen Dilution Technique in Acute Respiratory Distress Syndrome
Mechanical ventilation of the patient with acute respiratory distress syndrome is one of the first therapies.
Read the detailed description
The application of positive end expiratory pressure is recommended but the question remains "How to set the best positive end-expiratory pressure (PEEP) level for each patient? ". Different titration techniques have been studied on oxygenation and respiratory mechanics parameters without reaching a consensus. Currently we have a module that is connected to the ventilator to collect the patient's lung volume. It will therefore allow us to optimize the settings of the ventilator and to set the best level of positive end-expiratory pressure "best peep" in order to individualize our treatment for each patient.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- End-expiratory lung volume measurement and incremental PEEP titration
- Keywords
- respiratory distress, titration, end-expiratory
- Medical subject headings
- Respiratory Distress Syndrome, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
End-expiratory lung volume measurement and incremental PEEP titrationProcedure or surgery
- End expiratory lung volume measurement procedure according to the PEEP level set by the clinician, respecting a Vt at 6ml/kg IBW and Pplat<28cmH2o
- incremental PEEP titration procedure in 5 steps starting from 5cmH2o up to 20cmH2o
| Study group | Role | What they receive |
|---|---|---|
| experimental procedure | Experimental | * end-expiratory lung volume measurement procedure according to the PEEP level set by the clinician, respecting a Vt at 6ml/kg IBW and Pplat<28cmH2o
* incremental PEEP titration procedure in 5 steps starting from 5cmH2o up to 20cmH2o Receives: Procedure: End-expiratory lung volume measurement and incremental PEEP titration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observe end-expiratory lung volume change during an increasing PEEP titration procedure in patients with moderate to severe ARDS
Measured: 1 day
Secondary outcomes (6)
Define a threshold of end-expiratory lung volume variation to help determine optimal PEEP
Measured: 1 day
Analyzing the effect of PEEP titration on static compliance and dynamic strain
Measured: 1 day
Effect of PEEP titration on hematosis via the calculation of the Pao2/Fio2 ratio for each PEEP step thanks to the measurement of Pao2 on arterial gasometry
Measured: 1 day
Study the correlation between % change in end-expiratory lung volume and improvement in hematosis (Pao2/Fio2)
Measured: 1 day
Compare end-expiratory lung volume variations according to the type of ARDS (severity, focal or diffuse, pulmonary or extra-pulmonary etiology)
Measured: 1 day
Evaluate the hemodynamic tolerance of this procedure with the mean arterial pressure obtained by invasive blood pressure, noradrenaline dosage variation per procedure, lactate (obtained by arterial blood gas)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start20 Jan 2020
- Primary completion30 Nov 2020 (estimated)
- Study completion30 Nov 2020 (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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Aix-Pertuis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laurent LEFEBVRE, Centre Hospitalier Intercommunal Aix-Pertuis
- Investigators
- Laurent LEFEBVRE, Dr., Principal investigator, Centre Hospitalier Intercommunal Aix-Pertuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04352725
- Sponsor's protocol ID
- 20192211-1
- Acronym
- TIPEX-VOLTEX
- Status last verified
- Apr 2020
- First submitted
- 16 Apr 2020
- Last updated
- 20 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Casserly B, McCool FD, Saunders J, Selvakumar N, Levy MM. End-Expiratory Volume and Oxygenation: Targeting PEEP in ARDS Patients. Lung. 2016 Feb;194(1):35-41. doi: 10.1007/s00408-015-9823-6. Epub 2015 Dec 8.
PubMed 26645226Maggiore SM, Jonson B, Richard JC, Jaber S, Lemaire F, Brochard L. Alveolar derecruitment at decremental positive end-expiratory pressure levels in acute lung injury: comparison with the lower inflection point, oxygenation, and compliance. Am J Respir Crit Care Med. 2001 Sep 1;164(5):795-801. doi: 10.1164/ajrccm.164.5.2006071.
PubMed 11549535Olegard C, Sondergaard S, Houltz E, Lundin S, Stenqvist O. Estimation of functional residual capacity at the bedside using standard monitoring equipment: a modified nitrogen washout/washin technique requiring a small change of the inspired oxygen fraction. Anesth Analg. 2005 Jul;101(1):206-12, table of contents. doi: 10.1213/01.ANE.0000165823.90368.55.
PubMed 15976233Sahetya SK, Goligher EC, Brower RG. Fifty Years of Research in ARDS. Setting Positive End-Expiratory Pressure in Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2017 Jun 1;195(11):1429-1438. doi: 10.1164/rccm.201610-2035CI.
PubMed 28146639Dellamonica J, Lerolle N, Sargentini C, Beduneau G, Di Marco F, Mercat A, Richard JC, Diehl JL, Mancebo J, Rouby JJ, Lu Q, Bernardin G, Brochard L. PEEP-induced changes in lung volume in acute respiratory distress syndrome. Two methods to estimate alveolar recruitment. Intensive Care Med. 2011 Oct;37(10):1595-604. doi: 10.1007/s00134-011-2333-y. Epub 2011 Aug 25.
PubMed 21866369
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Positive End Expiratory Pressure Titration on the End-expiratory Lung Volume Measured by the Nitrogen Dilution Technique in Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT04352725
- Acronym / sponsor ID
- TIPEX-VOLTEX / 20192211-1
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- respiratory distress, titration, end-expiratory
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre Hospitalier Intercommunal Aix-PertuisUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 20 Apr 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.
Mechanical ventilation of the patient with acute respiratory distress syndrome is one of the first therapies.
Detailed description
The application of positive end expiratory pressure is recommended but the question remains "How to set the best positive end-expiratory pressure (PEEP) level for each patient? ". Different titration techniques have been studied on oxygenation and respiratory mechanics parameters without reaching a consensus. Currently we have a module that is connected to the ventilator to collect the patient's lung volume. It will therefore allow us to optimize the settings of the ventilator and to set the best level of positive end-expiratory pressure "best peep" in order to individualize our treatment for each patient.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental procedure | Experimental | Procedure: End-expiratory lung volume measurement and incremental PEEP titration* end-expiratory lung volume measurement procedure according to the PEEP level set by the clinician, respecting a Vt at 6ml/kg IBW and Pplat<28cmH2o * incremental PEEP titration procedure in 5 steps starting from 5cmH2o up to 20cmH2o |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients admitted to intensive care with a diagnosis of moderate to severe ARDS in accordance with the Berlin criteria, i.e. a PAFI <200 and PEEP >5cm H20 ratio
- Diagnosis of ARDS made within 72 hours
- Age over 18 years
- Informed consent of the patient and/or trusted person where applicable
Key exclusion criteria (20 listed)
- Start of mechanical ventilation more than 72 hours prior to inclusion.
- SDRA evolving for more than 72 hours
- Presence of major hemodynamic instability with mean blood pressure <60mmhg, and/or heart rate <45 bpm or >150bpm with an increase in vasopressor amine dosage of more than 20% over the last 6 hours.
- Intracranial hypertension with CPP<60mmhg
- Massive hemoptysis requiring immediate surgical or interventional radiology procedure
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 |
|---|---|---|
| End-expiratory lung volume measurement and incremental PEEP titration* End expiratory lung volume measurement procedure according to the PEEP level set by the clinician, respecting a Vt at 6ml/kg IBW and Pplat<28cmH2o * incremental PEEP titration procedure in 5 steps starting from 5cmH2o up to 20cmH2o | Procedure or surgery | experimental procedure |
Primary outcome
Observe end-expiratory lung volume change during an increasing PEEP titration procedure in patients with moderate to severe ARDS
Time frame: 1 day
6 secondary outcomes
Define a threshold of end-expiratory lung volume variation to help determine optimal PEEP
Time frame: 1 day
Analyzing the effect of PEEP titration on static compliance and dynamic strain
Time frame: 1 day
Effect of PEEP titration on hematosis via the calculation of the Pao2/Fio2 ratio for each PEEP step thanks to the measurement of Pao2 on arterial gasometry
Time frame: 1 day
Study the correlation between % change in end-expiratory lung volume and improvement in hematosis (Pao2/Fio2)
Time frame: 1 day
Compare end-expiratory lung volume variations according to the type of ARDS (severity, focal or diffuse, pulmonary or extra-pulmonary etiology)
Time frame: 1 day
Evaluate the hemodynamic tolerance of this procedure with the mean arterial pressure obtained by invasive blood pressure, noradrenaline dosage variation per procedure, lactate (obtained by arterial blood gas)
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
- Background: PubMed 26645226Casserly B, McCool FD, Saunders J, Selvakumar N, Levy MM. End-Expiratory Volume and Oxygenation: Targeting PEEP in ARDS Patients. Lung. 2016 Feb;194(1):35-41. doi: 10.1007/s00408-015-9823-6. Epub 2015 Dec 8.
- Background: PubMed 11549535Maggiore SM, Jonson B, Richard JC, Jaber S, Lemaire F, Brochard L. Alveolar derecruitment at decremental positive end-expiratory pressure levels in acute lung injury: comparison with the lower inflection point, oxygenation, and compliance. Am J Respir Crit Care Med. 2001 Sep 1;164(5):795-801. doi: 10.1164/ajrccm.164.5.2006071.
- Background: PubMed 15976233Olegard C, Sondergaard S, Houltz E, Lundin S, Stenqvist O. Estimation of functional residual capacity at the bedside using standard monitoring equipment: a modified nitrogen washout/washin technique requiring a small change of the inspired oxygen fraction. Anesth Analg. 2005 Jul;101(1):206-12, table of contents. doi: 10.1213/01.ANE.0000165823.90368.55.
- Background: PubMed 28146639Sahetya SK, Goligher EC, Brower RG. Fifty Years of Research in ARDS. Setting Positive End-Expiratory Pressure in Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2017 Jun 1;195(11):1429-1438. doi: 10.1164/rccm.201610-2035CI.
- Background: PubMed 21866369Dellamonica J, Lerolle N, Sargentini C, Beduneau G, Di Marco F, Mercat A, Richard JC, Diehl JL, Mancebo J, Rouby JJ, Lu Q, Bernardin G, Brochard L. PEEP-induced changes in lung volume in acute respiratory distress syndrome. Two methods to estimate alveolar recruitment. Intensive Care Med. 2011 Oct;37(10):1595-604. doi: 10.1007/s00134-011-2333-y. Epub 2011 Aug 25.
- 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.
Laurent LEFEBVRE, Dr. principal investigator
Centre Hospitalier Intercommunal Aix-Pertuis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing End-expiratory lung volume measurement and incremental PEEP titration in people with Acute Respiratory Distress Syndrome, run by Centre Hospitalier Intercommunal Aix-Pertuis 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 20 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 20 Apr 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 Agathe BOULANT (0442335650 ext. +33, aboulant@live.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observe end-expiratory lung volume change during an increasing PEEP titration procedure in patients with moderate to severe ARDS (time frame: 1 day). 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 NCT04352725, 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 20 Apr 2020.