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OpenTrials
Completed

NCT Number: NCT02036788

Comparison of Two Tests in the Assessment of the Accuracy of Esophageal Pressure Variations Measurement During Mechanical Ventilation

Esophageal pressure measurement, obtained with the use of an esophageal balloon catheter, is fundamental to assess mechanical characteristics of the respiratory system during mechanical ventilation. The correct positioning of the catheter (usually at the medium third of the esophagus) is crucial for an accurate measurement of esophageal pressure. Usually the correct positioning of the catheter is verified with an occlusion test (If the patient is breathing spontaneously) or with thoraco-abdominal compressions (if the patient is sedated and paralyzed). Aim of this study is to compare the accuracy of these two methods at different PEEP and esophageal catheter positions.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico

Milan, 20122, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Mechanical ventilation for clinical purposes

Exclusion criteria

  • Hemodynamic instability
  • Esophageal diseases
  • Refusal of the patient

Treatment and study plan

Occlusion test

Other

Occlusion test to assess the correct positioning of esophageal balloon catheter when the patient is breathing spontaneously.

Thoraco-abdominal compressions

Other

Thoraco-abdominal compressions to assess the correct positioning of esophageal balloon catheter when the patient is sedated and paralyzed.

Primary outcomes

  1. Correct esophageal catheter balloon position

    Time frame: 10 minutes after the start of the study

Sponsors and collaborators

Lead sponsor

Policlinico Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Jan 15, 2014
Registry last updated
Mar 30, 2016

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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