Power Dissipation in Flow-controlled Ventilation

NCT06222463 | Unknown DMC

• 1 other identifier: 1091/2023
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• power dissipation \[J/min\] during ventilation calculated by integrating the hysteresis of the tracheal pressure-volume loop
• applied mechanical power during ventilation calculated by published formulas \[1\]
• oxygenation of the blood assessed by PaO2/FiO2 ratio
• decarboxylation assessed by required respiratory minute volume to maintain normocapnia
• comparison of respiratory variables in low tidal volume versus individualized ventilation Participants will randomly receive either low tidal volume (LTV) or individualized flow-controlled ventilation \[2\]. In the LTV group, the positive end-expiratory pressure will be set to 5 cmH2O and the peak pressure set to achieve a tidal volume of 7 ml/kg predicted body weight. In the individualized group positive end-expiratory and peak pressure will be titrated to achieve the highest compliance \[2\]. In both groups the flow will be set to achieve normocapnia (PaCO2 35-45 mmHg). After obtaining three consecutive measurements the ventilation strategy will be switched to the alternative regime in a cross-over design and again, three measurements recorded. 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.

Conditions

Mechanical Ventilation; Abdominal Surgery

Keywords

Flow-controlled Ventilation; Power Dissipation; Mechanical Power

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (3)

• Mechanical power (MP)

  MP will be calculated and recorded three times in each treatment arm with 15 minutes in between.

• PaO2/FiO2 ratio

  PaO2/FiO2 ratio will be measured and recorded three times in each treatment arm with 15 minutes in between.

• Minute volume (MV)

  MV will be recorded three times in each treatment arm with 15 minutes in between

Other Outcomes (1)

• Respiratory measurement variables

  Respiratory measurement variables will be recorded three times in each treatment arm with 15 minutes in between

Study Arms (2)

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.

Device: Evone

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.

Device: Evone

Interventions

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.

individualized FCV; low tidal volume ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects ≥ 18 years
• Body weight ≥ 40 kg
• Elective open abdominal surgery under general anaesthesia - American Society of Anesthesiologists Classification I-III
• Written informed consent

You may not qualify if:

• Emergency surgery
• American Society of Anesthesiologists Classification IV-V
• Female subjects known to be pregnant
• Known participation in another interventional clinical trial

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

Medical University of Innsbruck

Innsbruck, Tyrol, 6020, Austria

RECRUITING

Related Publications (2)

• 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.

  PMID: 27620287 BACKGROUND

• 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.

  PMID: 37797394 BACKGROUND

Study Officials

• Patrick Spraider, PhD

  Medical University of Innsbruck, Department of Anesthesia and Intensive Care Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Spraider, PhD

CONTACT

+43 512 504 80329; patrick.spraider@i-med.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: non-blinded, randomized, cross-over, controlled trial

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: January 24, 2024
• Study Start: January 31, 2024
• Primary Completion: April 30, 2025
• Study Completion: May 30, 2025
• Last Updated: March 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)