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

NCT06541522 | Not Yet Recruiting

• 1 other identifier: REPEIT
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

ARDS

Keywords

ARDS; mechanical ventilation; EIT

Outcome Measures

Primary Outcomes (1)

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

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

  Day 0

Secondary Outcomes (3)

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

  Day 0

• Factors associated with a discordance between PEPEIT and PEPCRS

  Day 0

• Discrepancy between compliance measured according to impedance and compliance measured according to exhaled volume

  Day 0

Study Arms (1)

PEEP titrations

OTHER

Device: EIT

Interventions

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.

PEEP titrations

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Saint Joseph Saint Luc de Lyon: lead

Central Study Contacts

Samuel Tuffet, MD

CONTACT

+33(0)478618209; stuffet@saintjosephsaintluc.fr

Fanny Doroszewski, Mrs

CONTACT

+33(0)478618398; fdoroszewski@saintjosephsaintluc.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Once the patient is included in the research, two PEEP titrations monitored by EIT will be performed, each with the electrode belt positioned at a different chest height. The order will be drawn at random.

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 7, 2024
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: November 21, 2024

Record last verified: 2024-11