Assessment of Patient-ventilator Asynchrony by Electric Impedance Tomography

NCT06290310 | Not Yet Recruiting DMC

• 1 other identifier: PAVELA
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Patient-ventilator asynchrony (PVA) has deleterious effects on the lungs. PVA can lead to acute lung injury and worsening hypoxemia through biotrauma. Little is known about how PVA affects lung aeration estimated by electric impedance tomography (EIT). Artificial intelligence can promote the detection of PVA and with its help, EIT measurements can be correlated to asynchrony.

Conditions

Acute Lung Injury

Keywords

artificial intelligence; biotrauma; electric impedance tomography; patient-ventilator asynchrony

Outcome Measures

Primary Outcomes (1)

• distribution

  gas distribution in lungs assessed by electric impedance tomography

  during mechanical ventilation

Secondary Outcomes (2)

• connecting asysnchrony cycles with electric impedance tomography measurements

  during mechanical ventilation

• identifying unic electric impedance tomography signs of asynchrony

  during mechanical ventilation

Study Arms (1)

mechanically ventilated patients

Invasively or non-invasively ventilated patients.

Device: EIT; Device: patient-ventilator asynchrony assessment

Interventions

EIT DEVICE

continuous electric impedance tomography measurement

mechanically ventilated patients

patient-ventilator asynchrony assessment DEVICE

patient-ventilator asynchrony assessment by flow/time curve and machine learning

mechanically ventilated patients

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

mechanically ventilated patients

You may qualify if:

• any patient ventilated invasively
• any patient ventilated non-invasively

You may not qualify if:

• age under 18

Sponsors & Collaborators

• Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged: lead
• Hochschule Furtwangen University: collaborator
• Budapest University of Technology and Economics: collaborator
• Szeged University: collaborator

Study Sites (1)

Kiskunhalas Semmelweis Hopsital the Teaching Hospital of the University of Szeged

Kiskunhalas, 6400, Hungary

Location

Related Publications (2)

• Sottile PD, Albers D, Smith BJ, Moss MM. Ventilator dyssynchrony - Detection, pathophysiology, and clinical relevance: A Narrative review. Ann Thorac Med. 2020 Oct-Dec;15(4):190-198. doi: 10.4103/atm.ATM_63_20. Epub 2020 Oct 10.

  PMID: 33381233 RESULT

• Bachmann MC, Morais C, Bugedo G, Bruhn A, Morales A, Borges JB, Costa E, Retamal J. Electrical impedance tomography in acute respiratory distress syndrome. Crit Care. 2018 Oct 25;22(1):263. doi: 10.1186/s13054-018-2195-6.

  PMID: 30360753 RESULT

MeSH Terms

Conditions

Acute Lung Injury; Patient-Ventilator Asynchrony

Condition Hierarchy (Ancestors)

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

Central Study Contacts

András Lovas, M.D. Ph.D.

CONTACT

003677522000; landras@halasi-korhaz.hu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: March 4, 2024
• Study Start: April 12, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: March 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)