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Spirometry in Esophageal Intubation

This study has been completed.
Sponsor:
Information provided by:
University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT01080508
First received: March 3, 2010
Last updated: October 25, 2010
Last verified: October 2009
History of Changes
  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

Resource links provided by NLM:

U.S. FDA Resources

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

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01080508

Locations
Netherlands
University Medical Center Groningen, University of Groningen, the Netherlands
Groningen, Netherlands
Sponsors and Collaborators
University Medical Centre Groningen
Investigators
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.

Additional relevant MeSH terms:
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on June 17, 2013