Clinical Validation of Continuous and Non-invasive Monitoring of Effective Pulmonary Volume.

Clinical Validation of Continuous and Non-invasive Monitoring of Effective Pulmonary Volume Based on Exhaled CO2 Kinetics in Ventilated Patients.

The aim of this study is to evaluate/validate a new non-invasive method to continuously monitor effective lung volume in critically ill patients.

Study Overview

• Status: Completed
• Conditions: Critical Illness

Detailed Description

The capnodinamyc method is a new monitoring method that provides continuous (breath by breath) measurements of effective pulmonary blood flow (EPBF) and effective end-expiratory l lung volume (EELVCO2). The former refers to the non-shunted fraction of cardiac output and the latter to the functional end-expiratory lung volume (EELV) that contains CO2.

The capnodynamic method is based on the advanced analysis of CO2 kinetics and the law of Conservation of mass. It states that lungs have to eliminate a similar amounts of CO2 as produced by aerobic metabolism and reaches the lung via pulmonary perfusion. For its calculation, two different measurements are needed:

1. Exhaled CO2 measured by infrared optic sensor technology placed in a mainstream configuration between the endotracheal tube and the "Y" piece of the ventilator respiratory circuit.
2. Flow, airway pressure and ventilatory volumes measured by the mechanical ventilator spirometer.

The method requires the generation of cyclic small changes in the alveolar concentration of CO2 which is achieved by introducing a slightly modified breathing pattern. It consists of adding a short expiratory hold in each 3 out of 9 consecutive breaths and requires the patient to be in passive breathing conditions under mechanical ventilation.

EPBF and EELVCO2 have been validated in experimental conditions and the first validations in patients in the setting of general anesthesia are under way.

Methods:

This study on EELVCO2 in critically ill patients involves 2 types of evaluations:

The validation of absolute values of EELV by comparing it with CTsan. The trending ability of EELVCO2 in critically ill patients by comparing it with EIT.

A calculated sample size of 30 patients is required for each objective.

• Study Type: Observational
• Enrollment (Actual): 85

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28006
    • Hospital Universitario de la Princesa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients undergoing mechanical ventilation

Description

Inclusion Criteria:

• All patients on mechanical ventilation in passive breathing conditions in which a thoracic CTscan has been indicated for medical reasons and those with an EIT and a continuous cardiac monitoring
• Informed consent

Exclusion Criteria:

• Hemodynamic instability
• Presence of barotrauma/ pneumothorax
• Presence of bronchopleural fistulas
• Thorax alterations that preclude the positioning of the EIT electrode belt (usually at the IV intercostal space).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validation of the measurement of absolute values of effective lung volume	To validate the measurement of absolute values of effective lung volume by the capnodynamic method previously described, as an estimate of end-expiratory lung volume. For this purpose the capnodynamic method will be compared with gold standard reference method for measuring lung volumes, the computerized tomography scan (CTscan).	1 day
Analyze to which pulmonary compartments does effective lung volume most closely correlate	Tomographic aeration level according to the density distribution analysis (non aerated, poorly aerated, normally and hyper aerated) does effective lung volume most closely correlate; taking into account that the CTscan measures an anatomic rather than a functional lung volume.	1 day
Improvement of capnodynamic ELV measurement	To determine the effects of lung collapse on the accuracy and precision of the capnodynamic ELV measurement.	1 day
Trending ability of the capnodynamic end-expiratory lung volume method	Breath by breath changes in EELVCO2 will be compared with breath by breath changes in lung aeration measured by electrical impedance tomography.	1 day

Collaborators and Investigators

• Sponsor: Fernando Suarez Sipmann
• Investigators: Principal Investigator: Fernando Suarez Sipmann, MD PhD, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2019
• Primary Completion (Actual): March 30, 2022
• Study Completion (Actual): March 30, 2022

Study Registration Dates

• First Submitted: August 2, 2019
• First Submitted That Met QC Criteria: August 2, 2019
• First Posted (Actual): August 5, 2019

Study Record Updates

• Last Update Posted (Actual): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 9, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: EELVC02

Drug and device information, study documents

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