Esophageal Intubation Clinical Trial
Official title:
Analysis of the Spirometry Pattern in Esophageal Intubation
| 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 |
| Verified date | April 2024 |
| Source | University Medical Center Groningen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The primary objective of the study is to describe the pressure patterns during esophageal and tracheal ventilation and to validate the diagnostic algorithm.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | University Medical Center Groningen, University of Groningen, the Netherlands | Groningen |
| Lead Sponsor | Collaborator |
|---|---|
| University Medical Center Groningen |
Netherlands,
| 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 |