NCT02703012

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 5, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 9, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2019

Completed
Last Updated

April 19, 2019

Status Verified

April 1, 2019

Enrollment Period

3.3 years

First QC Date

February 5, 2016

Last Update Submit

April 17, 2019

Conditions

ARDS

Outcome Measures

Primary Outcomes (2)

  • Stress

    Percentage of patients with lung stress (defined as trans-pulmonary pressure during an end-inspiratory hold) below 27 mbar after 4 hours of adjustment of ventilator settings with the algorithm.

    4 hours

  • Strain

    Percentage of patients with lung strain (defined as end-inspiratory lung volume divided by functional residual capacity) below 2.0 after 4 hours of adjustment of ventilator settings with the algorithm.

    4 hours

Secondary Outcomes (4)

  • Compliance

    4 hours

  • Driving Pressure

    4 hours

  • Standard Deviation of regional ventilation delay

    4 hours

  • PaO2 / FiO2 Ratio

    4 hours

Study Arms (1)

Adjustment of ventilator settings by EIT

EXPERIMENTAL

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

Other: Adjustment of ventilator settings by EIT

Interventions

Adjustment of ventilator settings by EITOTHER

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.

Adjustment of ventilator settings by EIT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute Respiratory Distress Syndrome (according to Berlin Definition)

You may not qualify if:

  • 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
  • Inspiratory oxygen requirement \> 80%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Schleswig Holstein

Kiel, Schleswig-Holstein, 24103, Germany

Location

Related Publications (1)

  • 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.

    PMID: 34080074DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. N. Weiler

Study Record Dates

First Submitted

February 5, 2016

First Posted

March 9, 2016

Study Start

January 1, 2016

Primary Completion

April 4, 2019

Study Completion

April 4, 2019

Last Updated

April 19, 2019

Record last verified: 2019-04

Locations

DE(1)