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Clinical Trials/NCT04443491
NCT04443491
Completed
Not Applicable

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

University of Siena1 site in 1 country20 target enrollmentMay 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mechanical Ventilation
Sponsor
University of Siena
Enrollment
20
Locations
1
Primary Endpoint
Transpulmonary pressure
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2016
End Date
March 2019
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Federico Franchi

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

University of Siena

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

Outcomes

Primary Outcomes

Transpulmonary pressure

Time Frame: 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 Outcomes

  • Transpulmonary pressure in patients at risk for ventilator-induced-lung-injury(Within 72 hours from the starting of mechanical ventilation)
  • Transpulmonary pressure in subgroups of patients(Within 72 hours from the starting of mechanical ventilation)

Study Sites (1)

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