to study search History

Automated Minimization of Ventilator Energy to Improve Lung-Protective Ventilation

Organizational Data

DRKS-ID:
DRKS00013540
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2017-12-01
Last update in DRKS:
2018-07-25
Registration type:
Prospective

Acronym/abbreviation of the study

AUPROVENT

URL of the study

No Entry

Brief summary in lay language

Critically ill patients may sometimes require mechanical ventilation as part of their treatment on the intensive care unit (ICU). Modern ventilators are capable of delivering mechanical ventilation in a semi-automatic way, that automatically adapts to the changing lung conditions during the course of treatment. An existing semi-automatic ventilation mode ("Adaptive Ventilation Mode, AVM") was improved to deliver more lung-protective ventilation settings. The improved mode is called "AVM2". With this study we want to investigate whether AVM2 is really capable of delivering more lung-protective ventilation than AVM. To investigate this, we will ventilate ICU patients with both modes for one hour each in random order. We will compare ventilator settings, ventilation pressures and pulmonary gas exchange. The study duration will be about 2-3 hours. There will be no follow-up, so the study will be finished after 2-3 hours for individual patients.

Brief summary in scientific language

Adaptive Ventilation Mode (AVM) is a closed-loop fully automated method of mechanical ventilation. AVM adjusts ventilation parameters according to patient weight and lung condition, dynamically assessed by the ventilator. This is achieved by the implementation of the Otis equation, which, calculates f and Vtalv exactly in a way that minimal energy of respiratory work is required to reach MValv. Currently there are two ventilation modes on the market which follow this principle of the Otis equation (ASV, Hamilton Medical, Bonaduz, Switzerland and AVM, imtmedical AG, Buchs, Switzerland). Several studies imply that closed loop ventilation modes based on this equation by Otis (ASV, AVM) tend to apply relatively high tidal volumes, especially during mandatory ventilation. To reduce tidal volume and subsequently inspiration pressure, the controlling algorithm was changed to accomplish tidal volume and inspiratory pressure reductions (AVM2). The aim of this study is to compare the new algorithm of AVM2 with AVM in a randomized cross-over design. Subjects will be ventilated for 1 hour on each version of AVM, parameters of ventilation and hemodynamics will be documented constantly. As primary endpoint, we will compare tidal volume in ml per kg predicted Body weight. As secondary endpoints, we will compare delivered driving pressures, arterial partial pressures of oxygen and carbon dioxide as well as mechanical power of breathing, alveolar minute ventilation and mean arterial pressure.

Health condition or problem studied

Free text:
Invasive mechanical ventilation
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Ventilation with "Adaptive Ventilation Mode" (AVM) for 1 hour
Arm 2:
Ventilation with "Adaptive Ventilation Mode 2" (AVM2) for 1 hour

Endpoints

Primary outcome:
Tidal volume in ml per kg predicted body weight after one hour of mechanical ventilation with the respective mode (AVM or AVM2)
Secondary outcome:
- Driving pressure (Difference between airway plateau pressure and end-expiratory airway pressure, cmH2O) - power of breathing (J/min) - arterial partial pressure of oxygen (mmHg) - arterial partial pressure of carbon dioxide (mmHg) - pH - alveolar Minute Ventilation (l/min, calculated as (tidal volume - Serial dead space volume) * respiratory rate) - mean airway pressure (cmH2O) - mean arterial pressure (mmHg) - heart rate (1/min, ECG)

Study Design

Purpose:
Treatment
Allocation:
Randomized controlled study
Control:
  • Active control (effective treatment of control group)
Phase:
IV
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Crossover
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • University medical center Klinik für Anästhesiologie und Operative Intensivmedizin Kiel

Recruitment period and number of participants

Planned study start date:
2017-12-11
Actual study start date:
2017-12-11
Planned study completion date:
No Entry
Actual Study Completion Date:
2018-07-24
Target Sample Size:
20
Final Sample Size:
20

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
- Patients on invasive mechanical Ventilation on intensive care units - arterial line for invasive blood pressure measurement present - Age > 18 years - written informed consent

Exclusion Criteria

- expiratory time constant > 1.5 s - PaO2/FiO2 Ratio < 100 mmHg - arterial pH < 7.2 despite optimization of Ventilator Settings by treating ICU physician - arterial CO2 > 70 mmHg despite optimization of Ventilator Settings by treating ICU physician - acute severe hemodynamic instability (mean arterial pressure < 65 mmHg despite adequate therapy with fluid and/or vasopressors OR heart rate > 150/min OR heart rate < 40/min) - high frequency oscillatory Ventilation - spontaneous breathing activity

Addresses

Primary Sponsor

Universitätsklinikum Schleswig-Holstein
24103 Kiel
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Universitätsklinikum Schleswig-Holstein Campus Kiel, Klinik für Anästhesiologie und Operative Intensivmedizin
Dr. Tobias Becher
Arnold-Heller-Str. 3 Haus 12
24103 Kiel
Germany
Telephone:
+49 431 50020980
Fax:
No Entry
Contact per E-Mail
URL:
http://www.uni-kiel.de/anaesthesie

Contact for Public Queries

Universitätsklinikum Schleswig-Holstein Campus Kiel, Klinik für Anästhesiologie und Operative Intensivmedizin
Dr. Tobias Becher
Arnold-Heller-Str. 3 Haus 12
24103 Kiel
Germany
Telephone:
+49 431 50020980
Fax:
No Entry
Contact per E-Mail
URL:
http://www.uni-kiel.de/anaesthesie

Principal Investigator

Universitätsklinikum Schleswig-Holstein Campus Kiel, Klinik für Anästhesiologie und Operative Intensivmedizin
Dr. Tobias Becher
Arnold-Heller-Str. 3 Haus 12
24103 Kiel
Germany
Telephone:
+49 431 50020980
Fax:
No Entry
Contact per E-Mail
URL:
http://www.uni-kiel.de/anaesthesie

Sources of Monetary or Material Support

Commercial (pharmaceutical industry, medical engineering industry, etc.)

IMT Medical AG
Gewerbestrasse 8
CH - 9470 Buchs
Switzerland
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethik-Kommission der Medizinischen Fakultät der Christian-Albrechts-Universität zu Kiel
Schwanenweg 20
24105 Kiel
Germany
Telephone:
+49-431-50014191
Fax:
+49-431-50014195
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2017-10-12
Ethics committee number:
D 551/17
Vote of the Ethics Committee:
Approved
Date of the vote:
2017-11-20

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No Entry
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry