Spirometry in Esophageal Intubation

This study has been completed.
Information provided by:
University Medical Centre Groningen
ClinicalTrials.gov Identifier:
First received: March 3, 2010
Last updated: October 25, 2010
Last verified: October 2009

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 Centre Groningen:

Primary Outcome Measures:
  • Determination of the sensitivity and specificity of the algorithm to detect esophageal intubation. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pressure pattern of ventilation in esophageal and tracheal ventilation. [ Designated as safety issue: No ]

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
10 Asa I & II patients Other: ventilation after intubation with special tube
Description of the pressure waveforms during esophageal ventilation


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

ASA I & II patients


Inclusion Criteria:

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

Exclusion Criteria:

  • Expected difficulty for oral intubation.
  • Expected operation time >3 hours
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01080508

University Medical Center Groningen, University of Groningen, the Netherlands
Groningen, Netherlands
Sponsors and Collaborators
University Medical Centre Groningen
Principal Investigator: Alain F kalmar, Dr. University Medical Centre Groningen
  More Information

No publications provided by University Medical Centre Groningen

Additional 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
Study First Received: March 3, 2010
Last Updated: October 25, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

ClinicalTrials.gov processed this record on April 17, 2014