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

Acute Respiratory Distress Syndrome Clinical Trial

— PPLproject  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04443491
• Other study ID #: PPL project
• Status: Completed
• Start date: May 2016
• Est. completion date: March 2019

Study information

• Verified date: June 2020
• Source: University of Siena
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Mechanical Ventilation
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Universitaria Senese	Siena

Sponsors (1)

Lead Sponsor	Collaborator
University of Siena

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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