Effect of PEEP Titration on the EELV Measured by the Nitrogen Dilution Technique in ARDS

Acute Respiratory Distress Syndrome Clinical Trial

— TIPEX-VOLTEX  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04352725
• Other study ID #: 20192211-1
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: April 2020
• Source: Centre Hospitalier Intercommunal Aix-Pertuis
• Contact: Agathe BOULANT
• Phone: 0442335650
• Email: aboulant[@]live.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Mechanical ventilation of the patient with acute respiratory distress syndrome is one of the first therapies.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier Intercommunal Aix-Pertuis	Aix-en-Provence

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Aix-Pertuis

Country where clinical trial is conducted

France, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

Olegård C, Söndergaard 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. — View Citation

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. Review. Erratum in: Am J Respir Crit Care Med. 2018 Mar 1;197(5):684-685. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Observe end-expiratory lung volume change during an increasing PEEP titration procedure in patients with moderate to severe ARDS		1 day
Secondary	Define a threshold of end-expiratory lung volume variation to help determine optimal PEEP		1 day
Secondary	Analyzing the effect of PEEP titration on static compliance and dynamic strain		1 day
Secondary	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		1 day
Secondary	Study the correlation between % change in end-expiratory lung volume and improvement in hematosis (Pao2/Fio2)		1 day
Secondary	Compare end-expiratory lung volume variations according to the type of ARDS (severity, focal or diffuse, pulmonary or extra-pulmonary etiology)		1 day
Secondary	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)		1 day