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Completed

NCT Number: NCT04443491

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

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).

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliera Universitaria Senese

Siena, 53100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Transpulmonary pressure in subgroups of patients

    Time frame: 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

  2. Transpulmonary pressure in patients at risk for ventilator-induced-lung-injury

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Siena

Other

Registry information

Official study title

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

Acronym: PPLproject

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jun 23, 2020
Registry last updated
Jun 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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