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COPDNCT05812365

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

An observational study of COPD and Ventilator Lung, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COPD, Ventilator Lung, Anesthesia
How many people
10 participants
Where
1 siteGermany
Study dates
1 Jul 2024to 24 Jul 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Medical Center Hamburg-Eppendorf

    Hamburg, 20246

Other trials in Germany

About this study

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

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.

Read the 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).

Medical subject headings
Pulmonary Disease, Chronic Obstructive

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 1 hour after tracheal Intubation

Secondary outcomes (21)

  1. 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)

    Measured: 1 hour after tracheal intubation

  2. Dissipated energy

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

    Measured: 1 hour after tracheal intubation

  3. 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).

    Measured: 1 hour after tracheal intubation

  4. Applied mechanical power

    Calculated applied mechanical power during ventilation (J/min)

    Measured: 1 hour after tracheal intubation

  5. Ventilation distribution

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

    Measured: 1 hour after tracheal intubation

  6. Delta Z

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

    Measured: 1 hour after tracheal intubation

  7. Delta end-expiratory lung impedance

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

    Measured: 1 hour after tracheal intubation

  8. 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.

    Measured: 1 hour after tracheal intubation

  9. Regional lung compliance

    Calculated by electrical impedance tomography (ml/cm H2O)

    Measured: 1 hour after tracheal intubation

  10. Center of Ventilation

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

    Measured: 1 hour after tracheal intubation

  11. Global inhomogeneity index

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

    Measured: 1 hour after tracheal intubation

  12. arterial oxygen partial pressure (paO2)

    Measured by blood gas analysis (mmHg)

    Measured: 1 hour after tracheal intubation

  13. carbon dioxide partial pressure (pCO2)

    Measured by blood gas analysis (mmHg)

    Measured: 1 hour after tracheal intubation

  14. Horovitz quotient

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

    Measured: 1 hour after tracheal intubation

  15. Base excess

    Measured by blood gas analysis (mmol/l)

    Measured: 1 hour after tracheal intubation

  16. potential of hydrogen (pH)

    Measured by blood gas analysis

    Measured: 1 hour after tracheal intubation

  17. Resistance

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

    Measured: 1 hour after tracheal intubation

  18. tidal volume

    Measure by ventilator (ml)

    Measured: 1 hour after tracheal intubation

  19. Peak inspiratory pressure

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

    Measured: 1 hour after tracheal intubation

  20. Respiratory rate

    Measured by the ventilator (1/min)

    Measured: 1 hour after tracheal intubation

  21. End-tidal carbon dioxide (etCO2)

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

    Measured: 1 hour after tracheal intubation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2023
  2. Study start1 Jul 2024
  3. Primary completion24 Jul 2024
  4. Study completion24 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05812365
Sponsor's protocol ID
2023-101013
Other IDs
2023
Status last verified
Jul 2024
First submitted
2 Apr 2023
Last updated
25 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Blanco I, Diego I, Bueno P, Casas-Maldonado F, Miravitlles M. Geographic distribution of COPD prevalence in the world displayed by Geographic Information System maps. Eur Respir J. 2019 Jul 18;54(1):1900610. doi: 10.1183/13993003.00610-2019. Print 2019 Jul. No abstract available.

    PubMed 31000678

  • GBD 2015 Chronic Respiratory Disease Collaborators. Global, regional, and national deaths, prevalence, disability-adjusted life years, and years lived with disability for chronic obstructive pulmonary disease and asthma, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet Respir Med. 2017 Sep;5(9):691-706. doi: 10.1016/S2213-2600(17)30293-X. Epub 2017 Aug 16.

    PubMed 28822787

  • Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006 Nov;3(11):e442. doi: 10.1371/journal.pmed.0030442.

    PubMed 17132052

  • Dankert A, Neumann-Schirmbeck B, Dohrmann T, Greiwe G, Plumer L, Loser B, Sehner S, Zollner C, Petzoldt M. Preoperative Spirometry in Patients With Known or Suspected Chronic Obstructive Pulmonary Disease Undergoing Major Surgery: The Prospective Observational PREDICT Study. Anesth Analg. 2023 Oct 1;137(4):806-818. doi: 10.1213/ANE.0000000000006235. Epub 2022 Nov 1.

    PubMed 36730893

  • Tsuboi N, Tsuboi K, Nosaka N, Nishimura N, Nakagawa S. The Ventilatory Strategy to Minimize Expiratory Flow Rate in Ventilated Patients with Chronic Obstructive Pulmonary Disease. Int J Chron Obstruct Pulmon Dis. 2021 Feb 12;16:301-304. doi: 10.2147/COPD.S296343. eCollection 2021.

    PubMed 33603356

  • Barnes T, van Asseldonk D, Enk D. Minimisation of dissipated energy in the airways during mechanical ventilation by using constant inspiratory and expiratory flows - Flow-controlled ventilation (FCV). Med Hypotheses. 2018 Dec;121:167-176. doi: 10.1016/j.mehy.2018.09.038. Epub 2018 Sep 24.

    PubMed 30396474

  • Bauer M, Opitz A, Filser J, Jansen H, Meffert RH, Germer CT, Roewer N, Muellenbach RM, Kredel M. Perioperative redistribution of regional ventilation and pulmonary function: a prospective observational study in two cohorts of patients at risk for postoperative pulmonary complications. BMC Anesthesiol. 2019 Jul 27;19(1):132. doi: 10.1186/s12871-019-0805-8.

    PubMed 31351452

  • Borges JB, Cronin JN, Crockett DC, Hedenstierna G, Larsson A, Formenti F. Real-time effects of PEEP and tidal volume on regional ventilation and perfusion in experimental lung injury. Intensive Care Med Exp. 2020 Feb 21;8(1):10. doi: 10.1186/s40635-020-0298-2.

    PubMed 32086632

  • Dankert A, Dohrmann T, Loser B, Zapf A, Zollner C, Petzoldt M. Pulmonary Function Tests for the Prediction of Postoperative Pulmonary Complications. Dtsch Arztebl Int. 2022 Feb 18;119(7):99-106. doi: 10.3238/arztebl.m2022.0074.

    PubMed 34939921

Questions about this trial

What is this clinical trial studying?

An observational study of COPD and Ventilator Lung, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Best end-expiratory pressure (time frame: 1 hour after tracheal Intubation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05812365, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.

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