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

• Sponsor: Policlinico Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02036788
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Duration (Months): 21
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Pressure Measurement	Other: Occlusion test; Other: Thoraco-abdominal compressions

Study Design

• Study Type: Observational
• Actual Enrollment: 20 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Study Start Date: Dec 1, 2013
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Postsurgical patients sedated and paralized Patients admitted to ICU after surgery, treated with mechanical ventilation, sedated and paralized	Other: Thoraco-abdominal compressions; 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	Other: Occlusion test; Occlusion test to assess the correct positioning of esophageal balloon catheter when the patient is breathing spontaneously.

Outcome Measures

Primary Outcome Measures

1. Correct esophageal catheter balloon position [10 minutes after the start of the study]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Mechanical ventilation for clinical purposes

Exclusion Criteria:

• Hemodynamic instability

• Esophageal diseases

• Refusal of the patient

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico	Milan		Italy	20122

Sponsors and Collaborators

• Policlinico Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

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

• Responsible Party: Davide Chiumello, MD, Policlinico Hospital
• ClinicalTrials.gov Identifier: NCT02036788
• Other Study ID Numbers: Policlinico-11
• First Posted: Jan 15, 2014
• Last Update Posted: Mar 30, 2016
• Last Verified: Mar 1, 2016

• Keywords provided by Davide Chiumello, MD, Policlinico Hospital: Esophageal pressure, Mechanical ventilation

Study Results

No Results Posted as of Mar 30, 2016