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

Completed

• Conditions: Mechanical Ventilation; Acute Respiratory Distress Syndrome

• Registration Number: NCT04443491
• Lead Sponsor: University of Siena

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.

Study Timeline

• Study Start: 2016-05
• Primary Completion: 2019-03
• Study Completion: 2019-03
• Status Verified: 2020-06
• Study First Submitted: 2020-06-01
• Study First Submitted QC: 2020-06-21
• Last Update Submitted: 2020-06-21
• Study First Posted: 2020-06-23
• Last Update Posted: 2020-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Transpulmonary pressure	Within 72 hours from the starting of mechanical ventilation	Correlation and agreement between the transpulmonary pressure obtained from esophageal balloon catheter and central venous catheter

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Azienda Ospedaliera Universitaria Senese; 🇮🇹 Siena, Italy