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

March 3, 2010
October 25, 2010
December 2009
August 2010   (final data collection date for primary outcome measure)
Determination of the sensitivity and specificity of the algorithm to detect esophageal intubation. [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01080508 on ClinicalTrials.gov Archive Site
Pressure pattern of ventilation in esophageal and tracheal ventilation. [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Spirometry in Esophageal Intubation
Analysis of the Spirometry Pattern in Esophageal Intubation

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

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

ASA I & II patients

Esophageal Intubation
  • 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
  • 10 Asa I & II patients
    Intervention: Other: tracheal ventilation with regular tube
  • 10 Asa I & II patients
    Intervention: Other: ventilation after intubation with special tube
Kalmar AF, Absalom A, Monsieurs KG. A novel method to detect accidental oesophageal intubation based on ventilation pressure waveforms. Resuscitation. 2012 Feb;83(2):177-82. doi: 10.1016/j.resuscitation.2011.10.009. Epub 2011 Oct 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
August 2010
August 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01080508
Lazarus 001
No
Prof.dr. M.M.R.F.Sytruys, University Medical Center Groningen
University Medical Centre Groningen
Not Provided
Principal Investigator: Alain F kalmar, Dr. University Medical Centre Groningen
University Medical Centre Groningen
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP