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Spirometric Detection of Esophageal Intubation

Primary Purpose

Hypoxia, Hypoventilation

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
esophagus intubation
Sponsored by
University Medical Center Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypoxia focused on measuring endotracheal intubation, esophageal intubation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Medical Center Groningen

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

esophagus intubation

Arm Description

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.

Outcomes

Primary Outcome Measures

sensitivity/specificity of the fully-automatic device
Determine the sensitivity/specificity of the fully-automatic device to diagnose oesophageal intubation based on test ventilations

Secondary Outcome Measures

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"

Full Information

First Posted
January 28, 2014
Last Updated
January 30, 2014
Sponsor
University Medical Center Groningen
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1. Study Identification

Unique Protocol Identification Number
NCT02052869
Brief Title
Spirometric Detection of Esophageal Intubation
Official Title
Spirometric Detection of Esophageal Intubation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
August 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Groningen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia, Hypoventilation
Keywords
endotracheal intubation, esophageal intubation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
esophagus intubation
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
esophagus intubation
Intervention Description
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.
Primary Outcome Measure Information:
Title
sensitivity/specificity of the fully-automatic device
Description
Determine the sensitivity/specificity of the fully-automatic device to diagnose oesophageal intubation based on test ventilations
Time Frame
first 3 minutes after intubation
Secondary Outcome Measure Information:
Title
Evaluate the value of the supplementary algorithm
Description
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"
Time Frame
first 3 minutes of intubation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alain Kalmar, dr
Email
a.kalmar@umcg.nl
First Name & Middle Initial & Last Name or Official Title & Degree
rob spanjersberg
Email
r.spanjersberg@umcg.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alain Kalmar, MD PhD
Organizational Affiliation
University hosptal Medical Center Groningen,University of Groningen, The Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713EZ
Country
Netherlands

12. IPD Sharing Statement

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Spirometric Detection of Esophageal Intubation

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