Clinical trial NCT04443491: Comparison of Esophageal and Central Venous Pressure for Estimating Transpulmonary Pressure Changes
Official title: Estimating the Transpulmonary Pressure From the Central Venous Pressure in Mechanically Ventilated Patients With Respiratory Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mechanical Ventilation
Acute Respiratory Distress Syndrome
Keywords: esophageal pressure
transpulmonary pressure
central venous pressure
acute respiratory failure
Lead sponsor: University of Siena
Sponsor class: OTHER
First posted: 2020-06-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to ICU treated with mechanical ventilation.

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.

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

Primary outcomes:
measure: Transpulmonary pressure
timeFrame: Within 72 hours from the starting of mechanical ventilation
Secondary outcomes:
measure: Transpulmonary pressure in subgroups of patients
timeFrame: Within 72 hours from the starting of mechanical ventilation
measure: Transpulmonary pressure in patients at risk for ventilator-induced-lung-injury
timeFrame: Within 72 hours from the starting of mechanical ventilation
Other outcomes:
Locations:
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese
Study officials:
affiliation: University of Siena, Depatment of Medical Biotechnology
name: Federico Franchi, MD
role: PRINCIPAL_INVESTIGATOR
References: