Skip to main content
OpenTrials
Completed

NCT Number: NCT05812365

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

COPD Anesthesia Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Ventilator Lung

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Best end-expiratory pressure

    Time frame: 1 hour after tracheal Intubation

    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)

Secondary outcomes

  1. Best driving pressure

    Time frame: 1 hour after tracheal intubation

    Best driving pressure (peek pressure - end-expiratory pressure in mbar) associated with the best compliance, best tradeoff between alveolar collapse and hyper distension (EIT)

  2. Dissipated energy

    Time frame: 1 hour after tracheal intubation

    Calculated dissipated energy per liter of gas ventilated (J) during ventilation.

  3. Required minute volume to maintain carbon dioxide partial pressure (pCO2) level

    Time frame: 1 hour after tracheal intubation

    The minute volume (L/min) of the ventilator will be adjusted to maintain the preoperative baseline pCO2 level (blood gas analysis).

  4. Applied mechanical power

    Time frame: 1 hour after tracheal intubation

    Calculated applied mechanical power during ventilation (J/min)

  5. Ventilation distribution

    Time frame: 1 hour after tracheal intubation

    Expressed as the percentage of total pulmonary ventilation through each of the regions-of-interest, total 100%.

  6. Delta Z

    Time frame: 1 hour after tracheal intubation

    Measured variation of impedance (arbitrary units) by electrical impedance tomography.

  7. Delta end-expiratory lung impedance

    Time frame: 1 hour after tracheal intubation

    Variation of impedance plethysmography at end-expiration measured by electrical impedance tomography.

  8. Distribution of regional tidal ventilation

    Time frame: 1 hour after tracheal intubation

    Distribution of regional tidal ventilation will be determined as the relation of regional ΔZ/total ΔZ (expressed in percentage), measured by electrical impedance tomography.

  9. Regional lung compliance

    Time frame: 1 hour after tracheal intubation

    Calculated by electrical impedance tomography (ml/cm H2O)

  10. Center of Ventilation

    Time frame: 1 hour after tracheal intubation

    Variations of the pulmonary ventilation distribution in the ventral-dorsal and left-right direction measured by electrical impedance tomography.

  11. Global inhomogeneity index

    Time frame: 1 hour after tracheal intubation

    Impedance variations of each pixel between the end of inspiration and expiration measured by electrical impedance tomography.

  12. arterial oxygen partial pressure (paO2)

    Time frame: 1 hour after tracheal intubation

    Measured by blood gas analysis (mmHg)

  13. carbon dioxide partial pressure (pCO2)

    Time frame: 1 hour after tracheal intubation

    Measured by blood gas analysis (mmHg)

  14. Horovitz quotient

    Time frame: 1 hour after tracheal intubation

    Ratio of PaO2 (mmHg) and the fraction of oxygen of the inhaled air (FiO2).

  15. Base excess

    Time frame: 1 hour after tracheal intubation

    Measured by blood gas analysis (mmol/l)

  16. potential of hydrogen (pH)

    Time frame: 1 hour after tracheal intubation

    Measured by blood gas analysis

  17. Resistance

    Time frame: 1 hour after tracheal intubation

    Pressure change per flow change measured by the ventilator (kPa*s/l).

  18. tidal volume

    Time frame: 1 hour after tracheal intubation

    Measure by ventilator (ml)

  19. Peak inspiratory pressure

    Time frame: 1 hour after tracheal intubation

    Maximum pressure during the inspiration measured by the ventilator (mbar).

  20. Respiratory rate

    Time frame: 1 hour after tracheal intubation

    Measured by the ventilator (1/min)

  21. End-tidal carbon dioxide (etCO2)

    Time frame: 1 hour after tracheal intubation

    End-tidal carbon dioxide level measured by the ventilator (mmHg).

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Collaborators

  • Timple SA, Rua Simao Álvares 356 Conj. 41,42 e 51 - Pinheiros, Sao Paulo (Brasilien)
  • Ventinova Medical, Eindhoven, Netherlands

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 13, 2023
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.