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Completed

NCT Number: NCT04045262

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

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

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Key information

Conditions

Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario de la Princesa

Madrid, 28006, Spain

About this study

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:

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Validation of the measurement of absolute values of effective lung volume

    Time frame: 1 day

    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).

  2. Analyze to which pulmonary compartments does effective lung volume most closely correlate

    Time frame: 1 day

    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.

  3. Improvement of capnodynamic ELV measurement

    Time frame: 1 day

    To determine the effects of lung collapse on the accuracy and precision of the capnodynamic ELV measurement.

  4. Trending ability of the capnodynamic end-expiratory lung volume method

    Time frame: 1 day

    Breath by breath changes in EELVCO2 will be compared with breath by breath changes in lung aeration measured by electrical impedance tomography.

Sponsors and collaborators

Lead sponsor

Fernando Suarez Sipmann

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 5, 2019
Registry last updated
Oct 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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