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

NCT02036788 | Completed DMC

• 1 other identifier: Policlinico-11
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Esophageal Pressure Measurement

Keywords

Esophageal pressure, Mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Correct esophageal catheter balloon position

  10 minutes after the start of the study

Study Arms (2)

Postsurgical patients sedated and paralized

Patients admitted to ICU after surgery, treated with mechanical ventilation, sedated and paralized

Other: Thoraco-abdominal compressions

Postsurgical patients intubated and breathing spontaneously

Other: Occlusion test

Interventions

Occlusion test OTHER

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

Postsurgical patients intubated and 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.

Postsurgical patients sedated and paralized

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to ICU after surgery treated with mechanical ventilation

You may qualify if:

• Mechanical ventilation for clinical purposes

You may not qualify if:

• Hemodynamic instability
• Esophageal diseases
• Refusal of the patient

Sponsors & Collaborators

• Policlinico Hospital: lead

Study Sites (1)

Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Related Publications (5)

• McConville JF, Kress JP. Weaning patients from the ventilator. N Engl J Med. 2012 Dec 6;367(23):2233-9. doi: 10.1056/NEJMra1203367. No abstract available.

  PMID: 23215559 BACKGROUND

• 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.

  PMID: 18451319 BACKGROUND

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

  PMID: 22699701 BACKGROUND

• 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. doi: 10.1164/arrd.1982.126.5.788.

  PMID: 7149443 BACKGROUND

• 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. doi: 10.1097/00000542-198310000-00012.

  PMID: 6614543 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 13, 2014
• First Posted: January 15, 2014
• Study Start: December 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: September 1, 2015
• Last Updated: March 30, 2016

Record last verified: 2016-03

Locations

IT (1)