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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01080508
Other study ID # Lazarus 001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 2009
Est. completion date August 2010

Study information

Verified date April 2024
Source University Medical Center Groningen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date August 2010
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
tracheal ventilation with regular tube
Description of the pressure waveforms during tracheal ventilation
ventilation after intubation with special tube
Description of the pressure waveforms during esophageal ventilation

Locations

Country Name City State
Netherlands University Medical Center Groningen, University of Groningen, the Netherlands Groningen

Sponsors (1)

Lead Sponsor Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Determination of the sensitivity and specificity of the algorithm to detect esophageal intubation. during intubation
Secondary Pressure pattern of ventilation in esophageal and tracheal ventilation. during intubation