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Spirometry in Esophageal Intubation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01080508
First Posted: March 4, 2010
Last Update Posted: October 26, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Medical Center Groningen
  Purpose
The primary objective of the study is to describe the pressure patterns during esophageal and tracheal ventilation and to validate the diagnostic algorithm.

Condition Intervention
Esophageal Intubation Other: tracheal ventilation with regular tube Other: ventilation after intubation with special tube

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Analysis of the Spirometry Pattern in Esophageal Intubation

Further study details as provided by University Medical Center Groningen:

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

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

Estimated Enrollment: 40
Study Start Date: December 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

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 Submitted: March 3, 2010
First Posted: March 4, 2010
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.