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Best End-Expiratory and Driving-pressure for Individualized Flow Controlled Ventilation in Patients With COPD

Best End-Expiratory and Driving-Pressure for Individualized Flow Controlled Ventilation in Patients With COPD - an Observational Study.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05812365
Enrollment
10
Registered
2023-04-13
Start date
2024-07-01
Completion date
2024-07-24
Last updated
2024-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, COPD, Ventilator Lung

Brief summary

Patients with chronic obstructive pulmonary disease (COPD) have a significantly increased risk of postoperative pulmonary complications (PPC). Protective ventilation of the lungs could reduce the rate of PPC in patients with COPD. It has been suggested that flow controlled ventilation (FCV) may be less invasive and more protective to the lungs than conventional ventilation in patients with COPD. The primary aim of this study is to determine a optimal individual ventilation setting for FCV in ten participants with COPD.

Detailed description

The estimated worldwide chronic obstructive pulmonary disease (COPD) mean prevalence is 13.1%. In 2015, 3.2 million people died from COPD worldwide, and estimates show that COPD will be the third leading cause of death in 2030. Patients with COPD are at high risk for postoperative pulmonary complications (PPC). It has been proposed that FCV might be less-invasive and more protective for the lungs than conventional ventilation in patients with COPD. The pathophysiology of COPD is multifactorial, with the collapse of the central airways having a major impact on the symptoms. Minimizing the expiratory flow could prevent this airway pathology, and thus be beneficial in the ventilation of patients with COPD. In the operation theater participants will be ventilated with flow controlled ventilation (FCV). Arterial blood gas analysis and electrical impedance tomography (EIT) will be measured. The aim of the study is to determine the best end-expiratory pressure and driving pressure (assessed after anesthesia induction based on compliance and EIT parameters).

Interventions

None listed

Sponsors

Ventinova Medical, Eindhoven, Netherlands
CollaboratorUNKNOWN
Timple SA, Rua Simao Álvares 356 Conj. 41,42 e 51 - Pinheiros, Sao Paulo (Brasilien)
CollaboratorUNKNOWN
Universitätsklinikum Hamburg-Eppendorf
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients undergoing surgery with endotracheal intubation * Age ≥ 18 * Verified COPD (preoperative spirometry)

Exclusion criteria

* Pregnant woman * Laparoscopic surgery * Surgery that might interfere with EIT measurement * Cardiac Implantable Electronic Devices

Design outcomes

Primary

MeasureTime frameDescription
Best end-expiratory pressure1 hour after tracheal IntubationBest end-expiratory pressure (mbar), defined as the end-expiratory pressure associated with the best compliance, best tradeoff between alveolar collapse and hyper distension (EIT)

Secondary

MeasureTime frameDescription
Dissipated energy1 hour after tracheal intubationCalculated dissipated energy per liter of gas ventilated (J) during ventilation.
Required minute volume to maintain carbon dioxide partial pressure (pCO2) level1 hour after tracheal intubationThe minute volume (L/min) of the ventilator will be adjusted to maintain the preoperative baseline pCO2 level (blood gas analysis).
Applied mechanical power1 hour after tracheal intubationCalculated applied mechanical power during ventilation (J/min)
Ventilation distribution1 hour after tracheal intubationExpressed as the percentage of total pulmonary ventilation through each of the regions-of-interest, total 100%.
Delta Z1 hour after tracheal intubationMeasured variation of impedance (arbitrary units) by electrical impedance tomography.
Delta end-expiratory lung impedance1 hour after tracheal intubationVariation of impedance plethysmography at end-expiration measured by electrical impedance tomography.
Distribution of regional tidal ventilation1 hour after tracheal intubationDistribution of regional tidal ventilation will be determined as the relation of regional ΔZ/total ΔZ (expressed in percentage), measured by electrical impedance tomography.
Regional lung compliance1 hour after tracheal intubationCalculated by electrical impedance tomography (ml/cm H2O)
Center of Ventilation1 hour after tracheal intubationVariations of the pulmonary ventilation distribution in the ventral-dorsal and left-right direction measured by electrical impedance tomography.
Global inhomogeneity index1 hour after tracheal intubationImpedance variations of each pixel between the end of inspiration and expiration measured by electrical impedance tomography.
Best driving pressure1 hour after tracheal intubationBest driving pressure (peek pressure - end-expiratory pressure in mbar) associated with the best compliance, best tradeoff between alveolar collapse and hyper distension (EIT)
carbon dioxide partial pressure (pCO2)1 hour after tracheal intubationMeasured by blood gas analysis (mmHg)
Horovitz quotient1 hour after tracheal intubationRatio of PaO2 (mmHg) and the fraction of oxygen of the inhaled air (FiO2).
Base excess1 hour after tracheal intubationMeasured by blood gas analysis (mmol/l)
potential of hydrogen (pH)1 hour after tracheal intubationMeasured by blood gas analysis
Resistance1 hour after tracheal intubationPressure change per flow change measured by the ventilator (kPa\*s/l).
tidal volume1 hour after tracheal intubationMeasure by ventilator (ml)
Peak inspiratory pressure1 hour after tracheal intubationMaximum pressure during the inspiration measured by the ventilator (mbar).
Respiratory rate1 hour after tracheal intubationMeasured by the ventilator (1/min)
End-tidal carbon dioxide (etCO2)1 hour after tracheal intubationEnd-tidal carbon dioxide level measured by the ventilator (mmHg).
arterial oxygen partial pressure (paO2)1 hour after tracheal intubationMeasured by blood gas analysis (mmHg)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026