Spirometric Detection of Esophageal Intubation

Not Applicable

Withdrawn

• Conditions: Hypoxia; Hypoventilation
• Interventions: Procedure: esophagus intubation

• Registration Number: NCT02052869
• Lead Sponsor: University Medical Center Groningen

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.

Study Timeline

• Study First Submitted: 2014-01-28
• Study First Submitted QC: 2014-01-30
• Study First Posted: 2014-02-03
• Study Start: 2015-01
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
esophagus intubation	esophagus intubation	all patients will be intubated in the trachea first, with subsequent intubation in the esophagus. measurements will be performed on both tubes in a blinded manner.

Primary Outcome Measures

Name	Time	Method
sensitivity/specificity of the fully-automatic device	first 3 minutes after intubation	Determine the sensitivity/specificity of the fully-automatic device to diagnose oesophageal intubation based on test ventilations

Secondary Outcome Measures

Name	Time	Method
Evaluate the value of the supplementary algorithm	first 3 minutes of intubation	Evaluate the value of the supplementary algorithm to detect tube position without test ventilation. relying on only pressure waveform analysis during a conventional "thoracic push"

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands