An observational study in COPD, Ventilator Lung and Anesthesia, sponsored by Universitätsklinikum Hamburg-Eppendorf. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-25.
Sponsored by Universitätsklinikum Hamburg-Eppendorf · Observational
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.
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).
Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 403 studies on the registry; 83 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with verified COPD, scheduled for operations in general anesthesia, who present in the preassessment clinic of the University Medical Center Hamburg-Eppendorf during the study recruitment period, will be screened for eligibility.
Exclusion Criteria:
Best end-expiratory pressure
Best end-expiratory pressure (mbar), defined as the end-expiratory pressure associated with the best compliance, best tradeoff between alveolar collapse and hyper distension (EIT)
Time frame: 1 hour after tracheal Intubation
Best driving pressure
Best driving pressure (peek pressure - end-expiratory pressure in mbar) associated with the best compliance, best tradeoff between alveolar collapse and hyper distension (EIT)
Time frame: 1 hour after tracheal intubation
Dissipated energy
Calculated dissipated energy per liter of gas ventilated (J) during ventilation.
Time frame: 1 hour after tracheal intubation
Required minute volume to maintain carbon dioxide partial pressure (pCO2) level
The minute volume (L/min) of the ventilator will be adjusted to maintain the preoperative baseline pCO2 level (blood gas analysis).
Time frame: 1 hour after tracheal intubation
Applied mechanical power
Calculated applied mechanical power during ventilation (J/min)
Time frame: 1 hour after tracheal intubation
Ventilation distribution
Expressed as the percentage of total pulmonary ventilation through each of the regions-of-interest, total 100%.
Time frame: 1 hour after tracheal intubation
Delta Z
Measured variation of impedance (arbitrary units) by electrical impedance tomography.
Time frame: 1 hour after tracheal intubation
Delta end-expiratory lung impedance
Variation of impedance plethysmography at end-expiration measured by electrical impedance tomography.
Time frame: 1 hour after tracheal intubation
Distribution of regional tidal ventilation
Distribution of regional tidal ventilation will be determined as the relation of regional ΔZ/total ΔZ (expressed in percentage), measured by electrical impedance tomography.
Time frame: 1 hour after tracheal intubation
Regional lung compliance
Calculated by electrical impedance tomography (ml/cm H2O)
Time frame: 1 hour after tracheal intubation
Center of Ventilation
Variations of the pulmonary ventilation distribution in the ventral-dorsal and left-right direction measured by electrical impedance tomography.
Time frame: 1 hour after tracheal intubation
Global inhomogeneity index
Impedance variations of each pixel between the end of inspiration and expiration measured by electrical impedance tomography.
Time frame: 1 hour after tracheal intubation
arterial oxygen partial pressure (paO2)
Measured by blood gas analysis (mmHg)
Time frame: 1 hour after tracheal intubation
carbon dioxide partial pressure (pCO2)
Measured by blood gas analysis (mmHg)
Time frame: 1 hour after tracheal intubation
Horovitz quotient
Ratio of PaO2 (mmHg) and the fraction of oxygen of the inhaled air (FiO2).
Time frame: 1 hour after tracheal intubation
Base excess
Measured by blood gas analysis (mmol/l)
Time frame: 1 hour after tracheal intubation
potential of hydrogen (pH)
Measured by blood gas analysis
Time frame: 1 hour after tracheal intubation
Resistance
Pressure change per flow change measured by the ventilator (kPa\*s/l).
Time frame: 1 hour after tracheal intubation
tidal volume
Measure by ventilator (ml)
Time frame: 1 hour after tracheal intubation
Peak inspiratory pressure
Maximum pressure during the inspiration measured by the ventilator (mbar).
Time frame: 1 hour after tracheal intubation
Respiratory rate
Measured by the ventilator (1/min)
Time frame: 1 hour after tracheal intubation
End-tidal carbon dioxide (etCO2)
End-tidal carbon dioxide level measured by the ventilator (mmHg).
Time frame: 1 hour after tracheal intubation
Plan to share: No
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Universitätsklinikum Hamburg-Eppendorf