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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05812365
• Other study ID #: 2023-101013
• Status: Recruiting
• Start date: May 8, 2023
• Est. completion date: October 2023

Study information

• Verified date: May 2023
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: André Dankert, MD
• Phone: +4915222817660
• Email: a.dankert[@]uke.de
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: October 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• COPD
• Ventilator Lung

Locations

Country	Name	City	State
Germany	University Medical Center Hamburg-Eppendorf	Hamburg

Sponsors (3)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf	Timple SA, Rua Simao Álvares 356 Conj. 41,42 e 51 - Pinheiros, Sao Paulo (Brasilien), Ventinova Medical, Eindhoven, Netherlands

Country where clinical trial is conducted

Germany, 

References & Publications (9)

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. — View 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. — View 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. — View 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. — View 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. — View 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. 2022 Oct 29. doi: 10.1213/ANE.0000000000006235. Online ahead of print. — View 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. Erratum In: Lancet Respir Med. 2017 Oct;5(10 ):e30. — View 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. — View 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. — View Citation

Outcome

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