Clinical trial NCT05812365: Best End-Expiratory and Driving-pressure for Individualized Flow Controlled Ventilation in Patients With COPD
Official title: Best End-Expiratory and Driving-Pressure for Individualized Flow Controlled Ventilation in Patients With COPD - an Observational Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Ventilator Lung
Anesthesia
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: Ventinova Medical, Eindhoven, Netherlands
name: Timple SA, Rua Simao Álvares 356 Conj. 41,42 e 51 - Pinheiros, Sao Paulo (Brasilien)
First posted: 2023-04-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Best end-expiratory pressure
timeFrame: 1 hour after tracheal Intubation
Secondary outcomes:
measure: Best driving pressure
timeFrame: 1 hour after tracheal intubation
measure: Dissipated energy
timeFrame: 1 hour after tracheal intubation
measure: Required minute volume to maintain carbon dioxide partial pressure (pCO2) level
timeFrame: 1 hour after tracheal intubation
measure: Applied mechanical power
timeFrame: 1 hour after tracheal intubation
measure: Ventilation distribution
timeFrame: 1 hour after tracheal intubation
measure: Delta Z
timeFrame: 1 hour after tracheal intubation
measure: Delta end-expiratory lung impedance
timeFrame: 1 hour after tracheal intubation
measure: Distribution of regional tidal ventilation
timeFrame: 1 hour after tracheal intubation
measure: Regional lung compliance
timeFrame: 1 hour after tracheal intubation
measure: Center of Ventilation
timeFrame: 1 hour after tracheal intubation
measure: Global inhomogeneity index
timeFrame: 1 hour after tracheal intubation
measure: arterial oxygen partial pressure (paO2)
timeFrame: 1 hour after tracheal intubation
measure: carbon dioxide partial pressure (pCO2)
timeFrame: 1 hour after tracheal intubation
measure: Horovitz quotient
timeFrame: 1 hour after tracheal intubation
measure: Base excess
timeFrame: 1 hour after tracheal intubation
measure: potential of hydrogen (pH)
timeFrame: 1 hour after tracheal intubation
measure: Resistance
timeFrame: 1 hour after tracheal intubation
measure: tidal volume
timeFrame: 1 hour after tracheal intubation
measure: Peak inspiratory pressure
timeFrame: 1 hour after tracheal intubation
measure: Respiratory rate
timeFrame: 1 hour after tracheal intubation
measure: End-tidal carbon dioxide (etCO2)
timeFrame: 1 hour after tracheal intubation
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: André Dankert, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Martin Petzoldt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.