Best End-Expiratory and Driving-pressure for Individualized Flow Controlled Ventilation in Patients With COPD
Study Details
Study Description
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.
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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).
Study Design
Outcome Measures
Primary Outcome Measures
- Best end-expiratory pressure [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 Outcome Measures
- Best driving pressure [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)
- Dissipated energy [1 hour after tracheal intubation]
Calculated dissipated energy per liter of gas ventilated (J) during ventilation.
- Required minute volume to maintain carbon dioxide partial pressure (pCO2) level [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).
- Applied mechanical power [1 hour after tracheal intubation]
Calculated applied mechanical power during ventilation (J/min)
- Ventilation distribution [1 hour after tracheal intubation]
Expressed as the percentage of total pulmonary ventilation through each of the regions-of-interest, total 100%.
- Delta Z [1 hour after tracheal intubation]
Measured variation of impedance (arbitrary units) by electrical impedance tomography.
- Delta end-expiratory lung impedance [1 hour after tracheal intubation]
Variation of impedance plethysmography at end-expiration measured by electrical impedance tomography.
- Distribution of regional tidal ventilation [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.
- Regional lung compliance [1 hour after tracheal intubation]
Calculated by electrical impedance tomography (ml/cm H2O)
- Center of Ventilation [1 hour after tracheal intubation]
Variations of the pulmonary ventilation distribution in the ventral-dorsal and left-right direction measured by electrical impedance tomography.
- Global inhomogeneity index [1 hour after tracheal intubation]
Impedance variations of each pixel between the end of inspiration and expiration measured by electrical impedance tomography.
- arterial oxygen partial pressure (paO2) [1 hour after tracheal intubation]
Measured by blood gas analysis (mmHg)
- carbon dioxide partial pressure (pCO2) [1 hour after tracheal intubation]
Measured by blood gas analysis (mmHg)
- Horovitz quotient [1 hour after tracheal intubation]
Ratio of PaO2 (mmHg) and the fraction of oxygen of the inhaled air (FiO2).
- Base excess [1 hour after tracheal intubation]
Measured by blood gas analysis (mmol/l)
- potential of hydrogen (pH) [1 hour after tracheal intubation]
Measured by blood gas analysis
- Resistance [1 hour after tracheal intubation]
Pressure change per flow change measured by the ventilator (kPa*s/l).
- tidal volume [1 hour after tracheal intubation]
Measure by ventilator (ml)
- Peak inspiratory pressure [1 hour after tracheal intubation]
Maximum pressure during the inspiration measured by the ventilator (mbar).
- Respiratory rate [1 hour after tracheal intubation]
Measured by the ventilator (1/min)
- End-tidal carbon dioxide (etCO2) [1 hour after tracheal intubation]
End-tidal carbon dioxide level measured by the ventilator (mmHg).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients undergoing surgery with endotracheal intubation
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Age ≥ 18
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Verified COPD (preoperative spirometry)
Exclusion Criteria:
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Pregnant woman
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Laparoscopic surgery
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Surgery that might interfere with EIT measurement
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Cardiac Implantable Electronic Devices
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Medical Center Hamburg-Eppendorf | Hamburg | Germany | 20246 |
Sponsors and Collaborators
- Universitätsklinikum Hamburg-Eppendorf
- Ventinova Medical, Eindhoven, Netherlands
- Timple SA, Rua Simao Álvares 356 Conj. 41,42 e 51 - Pinheiros, Sao Paulo (Brasilien)
Investigators
- Principal Investigator: André Dankert, MD, Universitätsklinikum Hamburg-Eppendorf
- Principal Investigator: Martin Petzoldt, MD, Universitätsklinikum Hamburg-Eppendorf
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. 2022 Oct 29. doi: 10.1213/ANE.0000000000006235. Online ahead of print.
- 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. Erratum In: Lancet Respir Med. 2017 Oct;5(10 ):e30.
- 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.
- 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.
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