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

NCT ID: NCT04443491

Last Updated: 2020-06-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2019-03-31

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).

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.

Conditions

Mechanical Ventilation; Acute Respiratory Distress Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Siena

OTHER

Sponsor Role: lead

Responsible Party

Federico Franchi

Principal Investigator; Associate professor of Anesthesiology; Anesthesia and Intensive Care Unit, Department of Medicine, Surgery and Neuroscience, University of Siena, Siena, Italy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Federico Franchi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Siena, Depatment of Medical Biotechnology

Locations

Azienda Ospedaliera Universitaria Senese

Siena, , Italy

Countries

Italy

Other Identifiers

PPL project

Identifier Type: -

Identifier Source: org_study_id