Comparison of Esophageal and Central Venous Pressure for Estimating Transpulmonary Pressure Changes (PPLproject)

Estimating the Transpulmonary Pressure From the Central Venous Pressure in Mechanically Ventilated Patients With Respiratory Failure

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).

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Distress Syndrome; Mechanical Ventilation

Detailed Description

The investigators will enroll mechanically ventilated patients admitted to the intensive care unit with the diagnosis of respiratory failure monitored with a dedicated nasogastric catheter and a central venous catheter for measuring Pes and CVP, respectively. Electrocardiogram trace, Pes, CVP and airway pressure (Paw) will be recorded at the end of inspiratory and expiratory pauses. The CVP waveforms will be analyzed off-line using a dedicated low-pass digital filter to obtain the low-frequency component of CVP (filtered CVP, fCVP). Paw, Pes and fCVP will be used to calculate PL using transpulmonary driving pressure formula (PL-Pes and PL-fCVP, respectively). The PL values obtained with fCVP and Pes will be compared to assess the correlation of the two methods.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Italy
  • Siena, Italy, 53100
    • Azienda Ospedaliera Universitaria Senese

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients admitted to ICU treated with mechanical ventilation.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transpulmonary pressure in subgroups of patients	Agreement between trans pulmonary pressure obtained with the two methods in subgroup of patients such as those with acute respiratory distress syndrome or obesity	Within 72 hours from the starting of mechanical ventilation
Transpulmonary pressure in patients at risk for ventilator-induced-lung-injury	Comparison of the transpulmonary pressure obtained with the two methods in patients at risk for ventilator-induced-lung-injury	Within 72 hours from the starting of mechanical ventilation

Collaborators and Investigators

• Sponsor: University of Siena
• Investigators: Principal Investigator: Federico Franchi, MD, University of Siena, Depatment of Medical Biotechnology

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: June 1, 2020
• First Submitted That Met QC Criteria: June 21, 2020
• First Posted (Actual): June 23, 2020

Study Record Updates

• Last Update Posted (Actual): June 23, 2020
• Last Update Submitted That Met QC Criteria: June 21, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: transpulmonary pressure; acute respiratory failure; esophageal pressure; central venous pressure
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: PPL project

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No