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

Sponsor
University of Siena (Other)
Overall Status
Completed
CT.gov ID
NCT04443491
Collaborator
(none)
20
Enrollment
1
Location
34
Actual Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    20 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Estimating the Transpulmonary Pressure From the Central Venous Pressure in Mechanically Ventilated Patients With Respiratory Failure
    Actual Study Start Date :
    May 1, 2016
    Actual Primary Completion Date :
    Mar 1, 2019
    Actual Study Completion Date :
    Mar 1, 2019

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Azienda Ospedaliera Universitaria Senese Siena Italy 53100

    Sponsors and Collaborators

    • University of Siena

    Investigators

    • Principal Investigator: Federico Franchi, MD, University of Siena, Depatment of Medical Biotechnology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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, University of Siena
    ClinicalTrials.gov Identifier:
    NCT04443491
    Other Study ID Numbers:
    • PPL project
    First Posted:
    Jun 23, 2020
    Last Update Posted:
    Jun 23, 2020
    Last Verified:
    Jun 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by 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
    esophageal pressure
    transpulmonary pressure
    central venous pressure
    acute respiratory failure
    Additional relevant MeSH terms:
    Respiratory Distress Syndrome
    Respiratory Distress Syndrome, Newborn
    Acute Lung Injury

    Study Results

    No Results Posted as of Jun 23, 2020