Pulsed Eco Doppler for Polmonal Discharge Velocity

NCT06815198 | Recruiting

• 1 other identifier: VeLung
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

Chest ultrasound is increasingly being used in the diagnosis and management of the respiratory patient. With ultrasound, ultrasound artifacts representing the lung during inspiration and during exhalation are visualized and analyzed. During inspiration, the lung inflates with air while when exhaling, the lung empties. These two phases are visualized on ultrasound with a sliding motion of the pleural line, which represents the margin of the lung. The aim of the study is to identify the speed of filling and emptying of the lung by studying the characteristics of the pulsed Doppler wave to measure the speed of lung sliding as the significance of this finding has not yet been clarified. In both healthy subjects and patients with lung disease, it is not known whether there is a correlation between velocity measured by the Doppler wave with the main data recorded by a mechanical ventilator or spirometer.

Conditions

LUNG

Keywords

PULSED ECO DOPPLER, LUNG

Outcome Measures

Primary Outcomes (1)

• analyze, by ultrasound examination, the Doppler wave generated by lung sliding and measure the parenchyma sliding velocity

  The primary purpose of this study is to analyze, by ultrasound examination, the Doppler wave generated by lung sliding and measure the parenchyma sliding velocity in healthy subjects and in patients with established lung disease

  through study completion, an average of 1 year

Study Arms (2)

Group 1

The first group will include subjects without pulmonary disease who will be admitted to the pulmonology outpatient clinic, where they will undergo respiratory function and ultrasound tests simultaneously by two operators respectively

Group 2

The second group includes three subgroups of patients: 2a) Patients with chronic respiratory diseases referred to the Respiratory Diseases Unit of this Polyclinic classified according to the type of disease: COPD, Idiopathic Pulmonary Fibrosis, Pneumonia, Asthma in good control and exacerbation, neuromuscular diseases, ARDS (group2a). 2b) The patients without pulmonary diseases and undergoing elective surgery mechanically ventilated (group2b). 2c) The patients with pulmonary diseases undergoing surgery in the operating room surgery and/or admitted to the Multipurpose Intensive Care Unit and Respiratory Intensive Care Unit of this Polyclinic undergoing mechanical ventilation, categorized according to the type of lung disease specified in the previous point(group2c).

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

Patients belonging to the operating units involved in the study will be enrolled

You may qualify if:

• Age \>= 18 years
• Acquisition of Informed Consent

You may not qualify if:

• Patients admitted to undergo major thoracic surgery.
• Remote pathological history positive for recurrent PNX (≥ 2), pleural thalking or pleurodesis
• Patients presenting with absolute and relative contraindications to spirometry for1 and 2a patients ie:
• recent myocardial infarction (within the past 3 months) or unstable angina hemoptysis thoracic aortic aneurysm

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (2)

IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant'Orsola, UOC Anestesiologia e Terapia Intensiva Polivalente

Bologna, 40138, Italy

RECRUITING

IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola, UO Pneumologia

Bologna, 40138, Italy

RECRUITING

Study Officials

• Tommaso Tonetti, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna - Anestesiologia e Terapia Intensiva Polivalente

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tommaso Tonetti, MD

CONTACT

051 214 4309; tommaso.tonetti@unibo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: February 7, 2025
• Study Start: May 6, 2021
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: February 7, 2025

Record last verified: 2024-10

Locations

IT (2)