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

NCT ID: NCT02036788

Last Updated: 2016-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Esophageal Pressure Measurement

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Postsurgical patients sedated and paralized

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

Thoraco-abdominal compressions

Intervention Type OTHER

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

Postsurgical patients intubated and breathing spontaneously

Occlusion test

Intervention Type OTHER

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

Interventions

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Occlusion test

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

Intervention Type OTHER

Thoraco-abdominal compressions

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Mechanical ventilation for clinical purposes

Exclusion Criteria

* Hemodynamic instability
* Esophageal diseases
* Refusal of the patient
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Policlinico Hospital

OTHER

Sponsor Role lead

Responsible Party

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Davide Chiumello

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico

Milan, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 23215559 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18451319 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 22699701 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7149443 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6614543 (View on PubMed)

Other Identifiers

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Policlinico-11

Identifier Type: -

Identifier Source: org_study_id

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