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Spirometry in Esophageal Intubation

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ClinicalTrials.gov Identifier: NCT01080508
Recruitment Status : Completed
First Posted : March 4, 2010
Last Update Posted : October 26, 2010
Sponsor:
Information provided by:
University Medical Center Groningen

Brief Summary:
The primary objective of the study is to describe the pressure patterns during esophageal and tracheal ventilation and to validate the diagnostic algorithm.

Condition or disease Intervention/treatment
Esophageal Intubation Other: tracheal ventilation with regular tube Other: ventilation after intubation with special tube

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Analysis of the Spirometry Pattern in Esophageal Intubation
Study Start Date : December 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Group/Cohort Intervention/treatment
10 Asa I & II patients Other: tracheal ventilation with regular tube
Description of the pressure waveforms during tracheal ventilation
Other: ventilation after intubation with special tube
Description of the pressure waveforms during esophageal ventilation



Primary Outcome Measures :
  1. Determination of the sensitivity and specificity of the algorithm to detect esophageal intubation.

Secondary Outcome Measures :
  1. Pressure pattern of ventilation in esophageal and tracheal ventilation.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ASA I & II patients
Criteria

Inclusion Criteria:

  • Patients, requiring total anesthesia for a surgical procedure where the use of the easytube could be indicated.

Exclusion Criteria:

  • ASA III
  • Expected difficulty for oral intubation.
  • Expected operation time >3 hours

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01080508


Locations
Netherlands
University Medical Center Groningen, University of Groningen, the Netherlands
Groningen, Netherlands
Sponsors and Collaborators
University Medical Center Groningen
Investigators
Principal Investigator: Alain F kalmar, Dr. University Medical Center Groningen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof.dr. M.M.R.F.Sytruys, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT01080508     History of Changes
Other Study ID Numbers: Lazarus 001
First Posted: March 4, 2010    Key Record Dates
Last Update Posted: October 26, 2010
Last Verified: October 2009

Keywords provided by University Medical Center Groningen:
pressure pattern
esophageal and tracheal ventilation.
esophageal intubation.