Spirometric Detection of Esophageal Intubation

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.

Study Overview

• Status: Withdrawn
• Conditions: Hypoxia; Hypoventilation
• Intervention / Treatment: Procedure: esophagus intubation

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9713EZ
    • University Medical Center Groningen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Procedure: esophagus intubation; In these patients, automatic pressure waveform analysis is performed during the first three test ventilations on both the tracheal and oesophageal tube. ventilations will be performed by a blinded person. Subsequently, three conventional thoracic pushes will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sensitivity/specificity of the fully-automatic device	Determine the sensitivity/specificity of the fully-automatic device to diagnose oesophageal intubation based on test ventilations	first 3 minutes after intubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the value of the supplementary algorithm	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"	first 3 minutes of intubation

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Investigators: Principal Investigator: Alain Kalmar, MD PhD, University hosptal Medical Center Groningen,University of Groningen, The Netherlands

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: January 28, 2014
• First Submitted That Met QC Criteria: January 30, 2014
• First Posted (Estimated): February 3, 2014

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: endotracheal intubation; esophageal intubation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Hypoxia; Hypoventilation
• Other Study ID Numbers: Lazarus 003