Electrical Impedance Tomography Monitoring and Invasive Mechanical Ventilation During Pronation in Acute Respiratory Distress Syndrome.

NCT ID: NCT04605133

Last Updated: 2021-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-01

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Acute respiratory distress syndrome is an acute form of lung injury. The most commonly used classification criteria for this syndrome are Berlin's Criteria. The actual literature underlines the advantages of prone position in mild or severe forms of ARDS in association with invasive mechanical ventilation. The hypothesis of this study is to investigate the effective ventilation and perfusion modifications during pronation assessed with clinical parameters and with the aid of the electrical impedance tomography.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

ARDS, Human

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ARDS

Patients with mild or severe ARDS necessitating of prone position during mechanical ventilation

Electrical impedance tomography

Intervention Type DEVICE

Every patient is monitored with electrical impedance tomograpy before, during and after prone position.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Electrical impedance tomography

Every patient is monitored with electrical impedance tomograpy before, during and after prone position.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* mild or severe ARDS according to Berlin's Criteria
* recruitment maximum 72 hours from the diagnosis of ARDS

Exclusion Criteria

* other non-ARDS respiratory system pathologies
* hemodynamic instability (mean arterial pressure \< 60 mmHg)
* pneumothorax
* endocranial hypertension
* skin lesions or burns
* presence of pacemaker or implantable defibrillator
* pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Azienda Sanitaria-Universitaria Integrata di Udine

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Luigi Vetrugno

Clinical Professor in Anesthesiology and Intensive Care

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD

Udine, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

References

Explore related publications, articles, or registry entries linked to this study.

ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.

Reference Type BACKGROUND
PMID: 22797452 (View on PubMed)

Mauri T, Eronia N, Abbruzzese C, Marcolin R, Coppadoro A, Spadaro S, Patroniti N, Bellani G, Pesenti A. Effects of Sigh on Regional Lung Strain and Ventilation Heterogeneity in Acute Respiratory Failure Patients Undergoing Assisted Mechanical Ventilation. Crit Care Med. 2015 Sep;43(9):1823-31. doi: 10.1097/CCM.0000000000001083.

Reference Type BACKGROUND
PMID: 25985386 (View on PubMed)

Cinnella G, Grasso S, Raimondo P, D'Antini D, Mirabella L, Rauseo M, Dambrosio M. Physiological Effects of the Open Lung Approach in Patients with Early, Mild, Diffuse Acute Respiratory Distress Syndrome: An Electrical Impedance Tomography Study. Anesthesiology. 2015 Nov;123(5):1113-21. doi: 10.1097/ALN.0000000000000862.

Reference Type BACKGROUND
PMID: 26397017 (View on PubMed)

Scholten EL, Beitler JR, Prisk GK, Malhotra A. Treatment of ARDS With Prone Positioning. Chest. 2017 Jan;151(1):215-224. doi: 10.1016/j.chest.2016.06.032. Epub 2016 Jul 8.

Reference Type BACKGROUND
PMID: 27400909 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EIT during pronation in ARDS

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Lung EIT Image Guide Ventilation in ARDS
NCT07309783 NOT_YET_RECRUITING NA
Eit in ArdS for Tcav Setting (EAST Study)
NCT06408272 NOT_YET_RECRUITING