- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04352725
Effect of PEEP Titration on the EELV Measured by the Nitrogen Dilution Technique in ARDS (TIPEX-VOLTEX)
April 16, 2020 updated by: Laurent LEFEBVRE, Centre Hospitalier Intercommunal Aix-Pertuis
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Agathe BOULANT
- Phone Number: +33 0442335650
- Email: aboulant@live.fr
Study Locations
-
-
-
Aix-en-Provence, France, 13100
- Recruiting
- Centre Hospitalier Intercommunal Aix-Pertuis
-
Contact:
- Agathe BOULANT
- Phone Number: +33 0442335650
- Email: aboulant@live.fr
-
Sub-Investigator:
- Thibault HELBERT, Dr.
-
Sub-Investigator:
- Luc RODRIGUEZ, Dr.
-
Principal Investigator:
- Laurent LEFEBVRE, Dr.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: experimental procedure
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Observe end-expiratory lung volume change during an increasing PEEP titration procedure in patients with moderate to severe ARDS
Time Frame: 1 day
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Define a threshold of end-expiratory lung volume variation to help determine optimal PEEP
Time Frame: 1 day
|
1 day
|
Analyzing the effect of PEEP titration on static compliance and dynamic strain
Time Frame: 1 day
|
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
|
1 day
|
Study the correlation between % change in end-expiratory lung volume and improvement in hematosis (Pao2/Fio2)
Time Frame: 1 day
|
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
|
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
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Laurent LEFEBVRE, Dr., Centre Hospitalier Intercommunal Aix-Pertuis
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Maggiore 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.
- Dellamonica 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.
- 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.
- Olegard 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.
- Sahetya 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. Erratum In: Am J Respir Crit Care Med. 2018 Mar 1;197(5):684-685.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 20, 2020
Primary Completion (Anticipated)
November 30, 2020
Study Completion (Anticipated)
November 30, 2020
Study Registration Dates
First Submitted
April 16, 2020
First Submitted That Met QC Criteria
April 16, 2020
First Posted (Actual)
April 20, 2020
Study Record Updates
Last Update Posted (Actual)
April 20, 2020
Last Update Submitted That Met QC Criteria
April 16, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20192211-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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 Acute Respiratory Distress Syndrome
-
Tanta UniversityRecruitingAcute Lung Injury/Acute Respiratory Distress Syndrome (ARDS) | Respiratory Distress Syndrome, PediatricEgypt
-
University Hospital, Clermont-FerrandWithdrawn
-
China-Japan Friendship HospitalNot yet recruitingAcute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
-
Dr. Behcet Uz Children's HospitalRecruitingAcute Respiratory Distress Syndrome | Acute Respiratory Failure | Pediatric Acute Respiratory Distress Syndrome (PARDS)Turkey
-
Assistance Publique - Hôpitaux de ParisCompletedSevere Acute Respiratory Syndrome Coronavirus 2 | Severe Acute Respiratory Distress SyndromeFrance
-
Aqualung Therapeutics Corp.Not yet recruitingAcute Respiratory Distress Syndrome (ARDS)
-
Unity Health TorontoRecruitingAcute Respiratory Distress Syndrome (ARDS)Canada, Spain, Italy, Brazil
-
Western University, CanadaEnrolling by invitationCOVID-19 Acute Respiratory Distress SyndromeCanada
-
Ain Shams UniversityCompletedCOVID-19 Acute Respiratory Distress SyndromeEgypt
-
Hospices Civils de LyonTerminatedAcute Respiratory Distress Syndrome (ARDS)France
Clinical Trials on End-expiratory lung volume measurement and incremental PEEP titration
-
The First Affiliated Hospital of Guangzhou Medical...Recruiting
-
The Cleveland ClinicWithdrawnOne Lung Ventillation (OLV) | Two Lung Ventillation (TLV) | Positive End Expiratory Pressure (PEEP) | Zero End-expiratory Pressure (ZEEP)
-
Jiaxiang ChenEnrolling by invitation
-
University Hospital, AngersRecruiting
-
Columbia UniversityNational Heart, Lung, and Blood Institute (NHLBI)RecruitingVentilator-Induced Lung Injury | Sepsis Syndrome | Mechanical Ventilation ComplicationUnited States
-
Tanta UniversityRecruitingPostoperative Complications | Cardiac Surgery | Fluid OverloadEgypt
-
Kasr El Aini HospitalFayoum UniversityRecruitingChild | AnesthesiaEgypt
-
Seoul National University HospitalCompletedLung ComplianceKorea, Republic of
-
Sri Aurobindo Institute of Medical SciencesCompleted
-
Chinese Medical AssociationUnknownHypoxia | HypercapniaChina