Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-29 @ 9:05 PM
Study NCT ID:
NCT02052869
Status:
WITHDRAWN
Last Update Posted:
2024-04-17
First Post:
2014-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spirometric Detection of Esophageal Intubation
Sponsor:
University Medical Center Groningen
Organization:
Study Overview
Official Title:
Spirometric Detection of Esophageal Intubation
Status:
WITHDRAWN
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The PI has left the hopsital
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In endotracheal intubation, it is essential that the trachea is intubated and not the esophagus. In suboptimal situations (outside an operating theatre), malpositioning of the endotracheal tube occurs frequently and is often fatal. The diagnostic tools that are available in the operating theatre are not appropriate for out-of-hospital situations because of several reasons. Moreover, these methods mostly take some time to provide the desired information and don't have optimal specificity and sensitivity. In order to allow fast diagnosis of this potentially fatal complication, we have developed a fully-automatic detection device to diagnose endotracheal tube malpositioning within 2 seconds.
A high sensitivity/specificity of the algorithm for waveform-analysis was demonstrated in healthy patients and patients with pulmonary diseases (decreased pulmonary compliance).
A new stand-alone device with integrated sensors and microprocessor was developed that gives immediate diagnosis, and stores data for subsequent research purpose. This device will be evaluated in perioperative situations to demonstrate the high sensitivity and specificity in patients in a clinical setting.
A high sensitivity/specificity of the algorithm for waveform-analysis was demonstrated in healthy patients and patients with pulmonary diseases (decreased pulmonary compliance).
A new stand-alone device with integrated sensors and microprocessor was developed that gives immediate diagnosis, and stores data for subsequent research purpose. This device will be evaluated in perioperative situations to demonstrate the high sensitivity and specificity in patients in a clinical setting.
Detailed Description:
The fundamental algorithm for waveform analysis is unchanged, but an additional detection algorithm is incorporated for improved detection of ventilation efforts. In addition, sensors are integrated, automatic feedback electronics are improved, and the device is made more user friendly to be appropriate for out-of-hospital situations in demanding environments.
In addition, waveforms will be recorded for later analysis and evaluation of the diagnostic value of a thoracic push ( a gentle push on the sternum) to detect tube position.
In addition, waveforms will be recorded for later analysis and evaluation of the diagnostic value of a thoracic push ( a gentle push on the sternum) to detect tube position.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: