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

Effect of Positive End Expiratory Pressure Titration on the End-expiratory Lung Volume Measured by the Nitrogen Dilution Technique in Acute Respiratory Distress Syndrome

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04352725
Acronym
TIPEX-VOLTEX
Enrollment
40
Registered
2020-04-20
Start date
2020-01-20
Completion date
2020-11-30
Last updated
2020-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome

Keywords

respiratory distress, titration, end-expiratory

Brief summary

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.

Interventions

PROCEDUREEnd-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

Sponsors

Centre Hospitalier Intercommunal Aix-Pertuis
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Observe end-expiratory lung volume change during an increasing PEEP titration procedure in patients with moderate to severe ARDS1 day

Secondary

MeasureTime frame
Analyzing the effect of PEEP titration on static compliance and dynamic strain1 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 gasometry1 day
Define a threshold of end-expiratory lung volume variation to help determine optimal PEEP1 day
Compare end-expiratory lung volume variations according to the type of ARDS (severity, focal or diffuse, pulmonary or extra-pulmonary etiology)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)1 day
Study the correlation between % change in end-expiratory lung volume and improvement in hematosis (Pao2/Fio2)1 day

Countries

France

Contacts

Primary ContactAgathe BOULANT
aboulant@live.fr0442335650

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026