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

NCT04352725 | Unknown

• 1 other identifier: 20192211-1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Respiratory Distress Syndrome

Keywords

respiratory distress; titration; end-expiratory

Outcome Measures

Primary Outcomes (1)

• Observe end-expiratory lung volume change during an increasing PEEP titration procedure in patients with moderate to severe ARDS

  1 day

Secondary Outcomes (6)

• Define a threshold of end-expiratory lung volume variation to help determine optimal PEEP

  1 day

• Analyzing the effect of PEEP titration on static compliance and dynamic strain

  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

  1 day

• Study the correlation between % change in end-expiratory lung volume and improvement in hematosis (Pao2/Fio2)

  1 day

• Compare end-expiratory lung volume variations according to the type of ARDS (severity, focal or diffuse, pulmonary or extra-pulmonary etiology)

  1 day

Study Arms (1)

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

Procedure: End-expiratory lung volume measurement and incremental PEEP titration

Interventions

End-expiratory lung volume measurement and incremental PEEP titration PROCEDURE

* 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

experimental procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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%.

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Aix-Pertuis: lead

Study Sites (1)

Centre Hospitalier Intercommunal Aix-Pertuis

Aix-en-Provence, 13100, France

RECRUITING

Related 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.

  PMID: 26645226 BACKGROUND

• 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.

  PMID: 11549535 BACKGROUND

• 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.

  PMID: 15976233 BACKGROUND

• 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.

  PMID: 28146639 BACKGROUND

• 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.

  PMID: 21866369 BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome; Dyspnea

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Laurent LEFEBVRE, Dr.

  Centre Hospitalier Intercommunal Aix-Pertuis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Agathe BOULANT

CONTACT

0442335650; aboulant@live.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor, rescuer

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 20, 2020
• Study Start: January 20, 2020
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: April 20, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)