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.

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia; COPD; Ventilator Lung

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 Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • University Medical Center Hamburg-Eppendorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	1 hour after tracheal Intubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	1 hour after tracheal intubation
Dissipated energy	Calculated dissipated energy per liter of gas ventilated (J) during ventilation.	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).	1 hour after tracheal intubation
Applied mechanical power	Calculated applied mechanical power during ventilation (J/min)	1 hour after tracheal intubation
Ventilation distribution	Expressed as the percentage of total pulmonary ventilation through each of the regions-of-interest, total 100%.	1 hour after tracheal intubation
Delta Z	Measured variation of impedance (arbitrary units) by electrical impedance tomography.	1 hour after tracheal intubation
Delta end-expiratory lung impedance	Variation of impedance plethysmography at end-expiration measured by electrical impedance tomography.	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.	1 hour after tracheal intubation
Regional lung compliance	Calculated by electrical impedance tomography (ml/cm H2O)	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.	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.	1 hour after tracheal intubation
Base excess	Measured by blood gas analysis (mmol/l)	1 hour after tracheal intubation
Resistance	Pressure change per flow change measured by the ventilator (kPa*s/l).	1 hour after tracheal intubation
tidal volume	Measure by ventilator (ml)	1 hour after tracheal intubation
Peak inspiratory pressure	Maximum pressure during the inspiration measured by the ventilator (mbar).	1 hour after tracheal intubation
Respiratory rate	Measured by the ventilator (1/min)	1 hour after tracheal intubation
arterial oxygen partial pressure (paO2)	Measured by blood gas analysis (mmHg)	1 hour after tracheal intubation
carbon dioxide partial pressure (pCO2)	Measured by blood gas analysis (mmHg)	1 hour after tracheal intubation
Horovitz quotient	Ratio of PaO2 (mmHg) and the fraction of oxygen of the inhaled air (FiO2).	1 hour after tracheal intubation
potential of hydrogen (pH)	Measured by blood gas analysis	1 hour after tracheal intubation
End-tidal carbon dioxide (etCO2)	End-tidal carbon dioxide level measured by the ventilator (mmHg).	1 hour after tracheal intubation

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborators: 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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. doi: 10.1016/S2213-2600(17)30336-3.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): July 24, 2024
• Study Completion (Actual): July 24, 2024

Study Registration Dates

• First Submitted: April 2, 2023
• First Submitted That Met QC Criteria: April 2, 2023
• First Posted (Actual): April 13, 2023

Study Record Updates

• Last Update Posted (Actual): July 25, 2024
• Last Update Submitted That Met QC Criteria: July 24, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2023-101013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No