Comparison of Esophageal and Central Venous Pressure for Estimating Transpulmonary Pressure Changes

NCT04443491 | Completed DMC

• 1 other identifier: PPL project
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Central venous pressure (CVP) is characterized by a low-frequency pleural-dependent as well as a high-frequency cardiac pulsatile component. The aim of the study is to compare the low-frequency component of CVP with the esophageal pressure (Pes), as surrogate of pleural pressure, to estimate trans-pulmonary pressure (PL).

Conditions

Mechanical Ventilation; Acute Respiratory Distress Syndrome

Keywords

esophageal pressure; transpulmonary pressure; central venous pressure; acute respiratory failure

Outcome Measures

Primary Outcomes (1)

• Transpulmonary pressure

  Correlation and agreement between the transpulmonary pressure obtained from esophageal balloon catheter and central venous catheter

  Within 72 hours from the starting of mechanical ventilation

Secondary Outcomes (2)

• Transpulmonary pressure in subgroups of patients

  Within 72 hours from the starting of mechanical ventilation

• Transpulmonary pressure in patients at risk for ventilator-induced-lung-injury

  Within 72 hours from the starting of mechanical ventilation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients admitted to ICU treated with mechanical ventilation.

You may qualify if:

• adult patients receiving invasive mechanical ventilation
• diagnosis of acute respiratory failure (defined as the ratio of partial oxygen pressure and fraction of inspired oxygen below 200 mmHg)
• esophageal balloon catheter
• central venous catheter

You may not qualify if:

• age under 18 years old
• Hemodynamic instability
• Esophageal diseases (varices, stenosis..)
• Refusal of the patient
• evidence of active air leak from the lung (pneumothorax, pneumomediastinum, existing chest tube....)
• history of lung/abdominal surgery
• pregnancy
• severe coagulopathy

Sponsors & Collaborators

• University of Siena: lead

Study Sites (1)

Azienda Ospedaliera Universitaria Senese

Siena, 53100, Italy

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Federico Franchi, MD

  University of Siena, Depatment of Medical Biotechnology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator; Associate professor of Anesthesiology; Anesthesia and Intensive Care Unit, Department of Medicine, Surgery and Neuroscience, University of Siena, Siena, Italy

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 23, 2020
• Study Start: May 1, 2016
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: June 23, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)