Spirometric Detection of Esophageal Intubation

NCT ID: NCT02052869

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-01-31

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.

Conditions

Hypoxia; Hypoventilation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

esophagus intubation

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alain Kalmar, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University hosptal Medical Center Groningen,University of Groningen, The Netherlands

Locations

University Medical Center Groningen

Groningen, , Netherlands

Countries

Netherlands

Other Identifiers

Lazarus 003

Identifier Type: -

Identifier Source: org_study_id