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

NCT04045262 | Completed

• 1 other identifier: EELVC02
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Critical Illness

Outcome Measures

Primary Outcomes (4)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients undergoing mechanical ventilation

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fernando Suarez Sipmann: lead

Study Sites (1)

Hospital Universitario de la Princesa

Madrid, 28006, Spain

Location

Related Publications (1)

• Sanchez Giralt JA, Tusman G, Wallin M, Hallback M, Perez Lucendo A, Sanchez Galindo M, Abad Santamaria B, Paz Calzada E, Garcia Garcia P, Rodriguez Huerta D, Canabal Berlanga A, Suarez-Sipmann F. Clinical validation of a capnodynamic method for measuring end-expiratory lung volume in critically ill patients. Crit Care. 2024 Apr 30;28(1):142. doi: 10.1186/s13054-024-04928-w.

  PMID: 38689313 DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fernando Suarez Sipmann, MD PhD

  Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD PhD Intesive Care Medicine

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: August 5, 2019
• Study Start: June 4, 2019
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: October 12, 2022

Record last verified: 2022-10

Locations

ES (1)