Clinical trial NCT02052869: Spirometric Detection of Esophageal Intubation
Official title: Spirometric Detection of Esophageal Intubation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hypoxia
Hypoventilation
Keywords: endotracheal intubation
esophageal intubation
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2014-02-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: Inclusion Criteria:

* General anesthesia with endotracheal intubation required for the procedure
* Age: 18 years and older
* Total intravenous anesthesia with propofol (in order ro guarantee adequate hypnosis during the procedure)

Exclusion Criteria:

* Oesophageal pathology
* Patients at risk for desaturation (SpO2 \< 95%) if 20 seconds of apnoea is induced after adequate preoxygenation

Primary outcomes:
measure: sensitivity/specificity of the fully-automatic device
timeFrame: first 3 minutes after intubation
Secondary outcomes:
measure: Evaluate the value of the supplementary algorithm
timeFrame: first 3 minutes of intubation
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University hosptal Medical Center Groningen,University of Groningen, The Netherlands
name: Alain Kalmar, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: