Spirometric Detection of Esophageal Intubation

NCT02052869 | Withdrawn

• 1 other identifier: Lazarus 003
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxia; Hypoventilation

Keywords

endotracheal intubation; esophageal intubation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluate the value of the supplementary algorithm

  first 3 minutes of intubation

Study Arms (1)

esophagus intubation

OTHER

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

Interventions

esophagus intubation 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.

esophagus intubation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9713EZ, Netherlands

Location

MeSH Terms

Conditions

Hypoxia; Hypoventilation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Alain Kalmar, MD PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2014
• First Posted: February 3, 2014
• Study Start: January 1, 2015
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: April 17, 2024

Record last verified: 2024-04

Locations

NL (1)