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

Tracking Information

First Received Date ^ICMJE

March 3, 2010

Last Updated Date

October 25, 2010

Start Date ^ICMJE

December 2009

Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01080508 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Spirometry in Esophageal Intubation

Official Title ^ICMJE

Analysis of the Spirometry Pattern in Esophageal Intubation

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

ASA I & II patients

Condition ^ICMJE

Esophageal Intubation

Intervention ^ICMJE

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

Study Group/Cohort (s)

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

Publications *

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. Epub 2011 Oct 30.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

August 2010

Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT Number ^ICMJE

NCT01080508

Other Study ID Numbers ^ICMJE

Lazarus 001

Has Data Monitoring Committee

Responsible Party

Prof.dr. M.M.R.F.Sytruys, University Medical Center Groningen

Study Sponsor ^ICMJE

University Medical Centre Groningen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Alain F kalmar, Dr.

University Medical Centre Groningen

Information Provided By

University Medical Centre Groningen

Verification Date

October 2009

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

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