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NCT Number: NCT06541522

Impact of Belt Position on the Results of PEEP Titration by EIT During ARDS

ARDS is a frequent reason for hospitalization in intensive care. In order to improve its management, doctors seek to limit the mechanical ventilation-induced injuries (VILI) that can occur. PEEP is a parameter that plays a role in the appearance of VILI, and its adjustment can be optimized by EIT. The EIT is a non-invasive, non-irradiating, real-time monitoring device, today widely used for the optimization of ventilation in patients intubated for ARDS. The positioning of the EIT belt at different chest heights could influence the result of the PEEP titration.

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Key information

Conditions

ARDS

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The aim of this study is to test the hypothesis that the position (2nd intercostal space or 5th intercostal space) of the EIT (Electrical Impedance Tomography) belt significantly influences the result of PEEP (Positive Expiratory Pressure) titration.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Occurrence of moderate to severe ARDS (PaO2/FiO2 ratio ≤ 200 mmHg) within 72 hours following intubation
  • Criteria for moderate to severe ARDS for less than 72 hours
  • Passive ventilation in controlled assisted ventilation (no spontaneous ventilation)
  • Consent of next of kin

Exclusion criteria

  • Age < 18 years
  • ECMO
  • Pneumothorax
  • Pacemaker or implantable defibrillator
  • Chest trauma in the last 3 months
  • Skin peeling (Burned, Lyell)
  • Intracranial hypertension
  • Uncontrolled shock (noradrenaline >5 mg/h)
  • Pregnant woman
  • Adult patient protected within the meaning of the law
  • Lack of social security

Treatment and study plan

EIT

Device

Two PEEP titrations monitored by EIT will be performed, each with the electrode belt positioned at a different chest height (2nd intercostal space or 5th intercostal space). The order will be drawn at random.

Primary outcomes

  1. Impact of the position of the electrode belt on the results of PEEP titration by EIT.

    Time frame: Day 0

    Optimal PEEP determined by PEEP titration using the crossing point method.

Secondary outcomes

  1. Impact of the existence of intra-tidal recruitment on the discordance between PEPEIT and PEPCRS

    Time frame: Day 0

    Variability of the impedance variation during insufflation of the tidal volume ("tidal impedance variation) during titration measured by the relative interquartile coefficient (Q3-Q1)/median

  2. Factors associated with a discordance between PEPEIT and PEPCRS

    Time frame: Day 0

    Variability of the impedance variation during insufflation of the tidal volume ("tidal impedance variation) during titration measured by the relative interquartile coefficient (Q3-Q1)/median

  3. Discrepancy between compliance measured according to impedance and compliance measured according to exhaled volume

    Time frame: Day 0

    Regional ventilation delay (RVD)

Study contacts

Contact information is provided by the study sponsor or research team.

Fanny Doroszewski, Mrs

CONTACT

[email protected]

+33(0)478618398

Samuel Tuffet, MD

CONTACT

[email protected]

+33(0)478618209

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Saint Joseph Saint Luc de Lyon

Other

Registry information

Official study title

Impact of Belt Position on the Results of PEEP Titration by Electrical Impedance Tomography During Acute Respiratory Distress Syndrome

Acronym: REPEIT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 7, 2024
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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