Clinical trial NCT02703012: Clinical Application of Electrical Impedance Tomography for Individual Adjustment of Ventilator Settings
Official title: Pilot Clinical Study on Patient-Specific Adjustment of Ventilator Settings Using Electrical Impedance Tomography in Patients With Acute Respiratory Distress Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ARDS
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2016-03-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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%

Primary outcomes:
measure: Stress
timeFrame: 4 hours
measure: Strain
timeFrame: 4 hours
Secondary outcomes:
measure: Compliance
timeFrame: 4 hours
measure: Driving Pressure
timeFrame: 4 hours
measure: Standard Deviation of regional ventilation delay
timeFrame: 4 hours
measure: PaO2 / FiO2 Ratio
timeFrame: 4 hours
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: University Medical Center Schleswig Holstein
state: Schleswig-Holstein
Study officials:
References:
citation: 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.