Clinical Application of Electrical Impedance Tomography for Individual Adjustment of Ventilator Settings

NCT ID: NCT02703012

Last Updated: 2019-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2019-04-04

Brief Summary

First clinical application of an algorithm for individual adjustment of ventilator settings using electrical impedance tomography.

Detailed Description

In patients suffering from early Acute Respiratory Distress Syndrome (ARDS), an algorithm for individual adjustment of positive end-expiratory pressure and tidal volume will be applied. After optimization of ventilator settings according to the ARDS Network protocol, lung stress and strain, driving pressure, respiratory system compliance (Crs), regional ventilation delay and PaO2 / FiO2 ratio will be recorded. Subsequently, ventilator settings will be adjusted using an algorithm aiming at recruitment and avoiding tidal recruitment and overdistension using electrical impedance tomography (EIT). After 4 hours of EIT-based optimization ventilator settings, lung stress and strain, driving pressure, respiratory system compliance (Crs), regional ventilation delay and PaO2 / FiO2 ratio will be recorded again. The results will be compared to the ARDS Network approach.

Conditions

ARDS

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adjustment of ventilator settings by EIT

Individual Adjustment of Ventilator settings using an algorithm based on electrical impedance tomography.

Group Type: EXPERIMENTAL

Adjustment of ventilator settings by EIT

Intervention Type: OTHER

Diagnostic maneuvers (change in tidal volume, recruitment maneuvers) will be performed to detect overdistention, tidal recruitment and recruitability. Tidal volume will be reduced if overdistention is detected by EIT. Positive end-expiratory pressure will be increased if tidal recruitment or recruitability are detected.

Interventions

Adjustment of ventilator settings by EIT

Diagnostic maneuvers (change in tidal volume, recruitment maneuvers) will be performed to detect overdistention, tidal recruitment and recruitability. Tidal volume will be reduced if overdistention is detected by EIT. Positive end-expiratory pressure will be increased if tidal recruitment or recruitability are detected.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Acute Respiratory Distress Syndrome (according to Berlin Definition)

Exclusion Criteria

• Hemodynamic Instability (defined as mean arterial pressure < 65 mmHg OR heart rate < 40 / min OR heart rate > 150 / min OR cardiac index < 2.0 l/min/m^2 DESPITE adequate fluid resuscitation and adequate therapy with inotropes and / or vasopressors)
• Thoracic burns or severe skin injuries
• High frequency oscillatory ventilation
• Pregnancy
• Severe chronic obstructive pulmonary disease (GOLD IV)
• Esophageal varices > grade I
• Esophageal resection
• Invasive ventilation prior to study inclusion for more than 72 hours after onset of ARDS
• Inspiratory oxygen requirement > 80%

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Schleswig-Holstein

OTHER

Sponsor Role: lead

Responsible Party

Norbert Weiler

Prof. N. Weiler

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Medical Center Schleswig Holstein

Kiel, Schleswig-Holstein, Germany

Countries

Germany

References

Becher T, Buchholz V, Hassel D, Meinel T, Schadler D, Frerichs I, Weiler N. Individualization of PEEP and tidal volume in ARDS patients with electrical impedance tomography: a pilot feasibility study. Ann Intensive Care. 2021 Jun 2;11(1):89. doi: 10.1186/s13613-021-00877-7.

Reference Type: DERIVED

PMID: 34080074 (View on PubMed)

Other Identifiers

UKSH-EIT-01

Identifier Type: -

Identifier Source: org_study_id