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The goal of this randomized clinical cross-over trial is to compare power dissipation (Pd) during flow-controlled ventilation with either standard of low tidal volume ventilation or compliance guided individualization of ventilator settings. This study is performed in patients scheduled for open abdominal surgery and the primary and secondary outcome parameters are:
The investigators hypothesize, that individualized ventilator settings are able to improve ventilation efficiency in terms of a lower required minute volume to maintain normocapnia and thus is able to reduce power dissipation during ventilation. Secondary endpoint will be a comparison of Pd to calculated mechanical power, as a currently accepted surrogate parameter for ventilation invasiveness [2] and also outcome predictor. Additionally, gas exchange parameters such as oxygenation and decarboxylation will be compared between low tidal volume and individualized ventilation.
After anesthesia induction and securing the airway with a tracheal tube, tha patients will be ventilated with flow-controlled ventilation (FCV) using standard of low tidal volume ventilation with a positive end-expiratory pressure (PEEP) of 5 cmH2O and the peak pressure set to achieve a tidal volume of 7 ml/kg predicted body weight. I:E ration will be set to 1:1, the gas flow adjusted to achieve normocapnia and the fraction of inspired oxygen adjusted to achieve normoxia. After opening the abdominal cavity baseline parameters will be recorded and subsequently the study participant randomized to one of the following treatment group:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low tidal volume ventilation | Active Comparator | Flow-controlled ventilation will be established with a PEEP of 5 cmH2O, peak pressure set to achieve a tidal volume of 7 ml/kg predicted body weight and the flow set to achieve normocapnia at an I:E ration of 1:1. Three consecutive measurements of power dissipation with 15 minutes in between will be obtained. Additionally secondary outcome parameters such as respiratory parameters and results of arterial blood gas analysis will be recorded at each measurement timepoint. |
|
| individualized FCV | Experimental | Flow-controlled ventilation will be individualized with compliance guided PEEP and peak pressure titration. The flow will be set to achieve normocapnia at an I:E ration of 1:1. Three consecutive measurements of power dissipation with 15 minutes in between will be obtained. Additionally secondary outcome parameters such as respiratory parameters and results of arterial blood gas analysis will be recorded at each measurement timepoint. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evone | Device | Evone (Ventinova Medical B.V., Eindhoven, The Netherlands) is a ventilator, which is able to perform flow-controlled ventilation (FCV). Moreover it provides direct tracheal pressure measurements and combined with the constant gas flow of FCV a precise determination of dynamic compliance is feasible. Thus not only PEEP but also peak pressure can be titrated based on dynamic compliance. Additionally intratracheal pressure-volume loops can be measured and thus power dissipation calculated, which represents the primary outcome parameter of this trial. |
| Measure | Description | Time Frame |
|---|---|---|
| Power dissipation (Pd) | The hysteresis of the tracheal pressure-volume relationship represents the power, that is dissipated during one ventilation cycle. Together with the respiratory rate, overall power dissipation can be calculated in J/min. | Pd will be calculated and recorded three times in each treatment arm with 15 minutes in between. |
| Measure | Description | Time Frame |
|---|---|---|
| Mechanical power (MP) | Applied mechanical power during inspiration will be calculated based on a published formula by Gattinoni et al. | MP will be calculated and recorded three times in each treatment arm with 15 minutes in between. |
| PaO2/FiO2 ratio |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory measurement variables | Ventilator settings and readings with positive end-expiratory pressure, peak pressure, respiratory rat, flow rate, compliance and resistance will be recorded. | Respiratory measurement variables will be recorded three times in each treatment arm with 15 minutes in between |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrick Spraider, PhD | Contact | +43 512 504 80329 | patrick.spraider@i-med.ac.at |
| Name | Affiliation | Role |
|---|---|---|
| Patrick Spraider, PhD | Medical University of Innsbruck, Department of Anesthesia and Intensive Care Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Innsbruck | Recruiting | Innsbruck | Tyrol | 6020 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27620287 | Background | Gattinoni L, Tonetti T, Cressoni M, Cadringher P, Herrmann P, Moerer O, Protti A, Gotti M, Chiurazzi C, Carlesso E, Chiumello D, Quintel M. Ventilator-related causes of lung injury: the mechanical power. Intensive Care Med. 2016 Oct;42(10):1567-1575. doi: 10.1007/s00134-016-4505-2. Epub 2016 Sep 12. | |
| 37797394 | Background |
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The IPD can be requested from the principal investigator.
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non-blinded, randomized, cross-over, controlled trial
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Oxygenation will be assessed with the help of an arterial blood gas analysis
| PaO2/FiO2 ratio will be measured and recorded three times in each treatment arm with 15 minutes in between. |
| Minute volume (MV) | Required respiratory minute volume to maintain normocapnia will be recorded. | MV will be recorded three times in each treatment arm with 15 minutes in between |
| Spraider P, Abram J, Martini J, Putzer G, Glodny B, Hell T, Barnes T, Enk D. Flow-controlled versus pressure-controlled ventilation in cardiac surgery with cardiopulmonary bypass - A single-center, prospective, randomized, controlled trial. J Clin Anesth. 2023 Dec;91:111279. doi: 10.1016/j.jclinane.2023.111279. Epub 2023 Oct 3. |