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NCT02036788 Clinical Trial

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

Esophageal Pressure Measurement Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02036788
Other study ID # Policlinico-11
Secondary ID
Status Completed
Phase N/A
First received January 13, 2014
Last updated March 29, 2016
Start date December 2013
Est. completion date September 2015

Study information
Verified date March 2016
Source Policlinico Hospital
Contact n/a
Is FDA regulated No
Health authority Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date September 2015
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- Mechanical ventilation for clinical purposes

Exclusion Criteria:

- Hemodynamic instability

- Esophageal diseases

- Refusal of the patient

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• Occlusion test
Occlusion test to assess the correct positioning of esophageal balloon catheter when the patient is breathing spontaneously.
• Thoraco-abdominal compressions
Thoraco-abdominal compressions to assess the correct positioning of esophageal balloon catheter when the patient is sedated and paralyzed.

Locations
Country Name City State
Italy Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico Milan

Sponsors (1)
Lead Sponsor Collaborator
Policlinico Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Baydur A, Behrakis PK, Zin WA, Jaeger M, Milic-Emili J. A simple method for assessing the validity of the esophageal balloon technique. Am Rev Respir Dis. 1982 Nov;126(5):788-91. — View Citation

Chiumello D, Carlesso E, Cadringher P, Caironi P, Valenza F, Polli F, Tallarini F, Cozzi P, Cressoni M, Colombo A, Marini JJ, Gattinoni L. Lung stress and strain during mechanical ventilation for acute respiratory distress syndrome. Am J Respir Crit Care Med. 2008 Aug 15;178(4):346-55. doi: 10.1164/rccm.200710-1589OC. Epub 2008 May 1. — View Citation

Hedenstierna G. Esophageal pressure: benefit and limitations. Minerva Anestesiol. 2012 Aug;78(8):959-66. Epub 2012 Jun 14. — View Citation

Higgs BD, Behrakis PK, Bevan DR, Milic-Emili J. Measurement of pleural pressure with esophageal balloon in anesthetized humans. Anesthesiology. 1983 Oct;59(4):340-3. — View Citation

McConville JF, Kress JP. Weaning patients from the ventilator. N Engl J Med. 2012 Dec 6;367(23):2233-9. doi: 10.1056/NEJMra1203367. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Correct esophageal catheter balloon position 10 minutes after the start of the study Yes