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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00013540 |
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Date of registration:
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01/12/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Automated Minimization of Ventilator Energy to Improve Lung-Protective Ventilation
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Scientific title:
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Automated Minimization of Ventilator Energy to Improve Lung-Protective Ventilation - AUPROVENT |
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Date of first enrolment:
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11/12/2017 |
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Target sample size:
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20 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00013540 |
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Study type:
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interventional |
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Study design:
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Allocation: Randomized controlled study; Masking: Open (masking not used); Control: active; Assignment: crossover; Study design purpose: treatment
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Phase:
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4
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Countries of recruitment
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Germany
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Contacts
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Name:
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Tobias
Becher |
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Address:
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Arnold-Heller-Str. 3 Haus 12
24103
Kiel
Germany |
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Telephone:
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+49 431 50020980 |
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Email:
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tobias.becher@uksh.de |
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Affiliation:
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Universitätsklinikum Schleswig-Holstein Campus Kiel, Klinik für Anästhesiologie und Operative Intensivmedizin |
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Name:
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Tobias
Becher |
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Address:
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Arnold-Heller-Str. 3 Haus 12
24103
Kiel
Germany |
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Telephone:
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+49 431 50020980 |
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Email:
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tobias.becher@uksh.de |
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Affiliation:
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Universitätsklinikum Schleswig-Holstein Campus Kiel, Klinik für Anästhesiologie und Operative Intensivmedizin |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
None
Gender:
All
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Health Condition(s) or Problem(s) studied
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Invasive mechanical ventilation
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Intervention(s)
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Group 1: Ventilation with "Adaptive Ventilation Mode" (AVM) for 1 hour
Group 2: Ventilation with "Adaptive Ventilation Mode 2" (AVM2) for 1 hour
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Primary Outcome(s)
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Tidal volume in ml per kg predicted body weight after one hour of mechanical ventilation with the respective mode (AVM or AVM2)
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Secondary Outcome(s)
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- 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)
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Source(s) of Monetary Support
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IMT Medical AG
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Ethics review
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Status: Approved
Approval date: 20/11/2017
Contact:
ethikkomm@email.uni-kiel.de
Ethik-Kommission der Medizinischen Fakultät der Christian-Albrechts-Universität zu Kiel
+49-431-50014191
ethikkomm@email.uni-kiel.de
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