HypoxiaNCT02052869
Spirometric Detection of Esophageal Intubation
A study testing esophagus intubation in people with Hypoxia and Hypoventilation, run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxia, Hypoventilation
- What is being tested?
- esophagus intubation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2015to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Oesophageal pathology
- Patients at risk for desaturation (SpO2 < 95%) if 20 seconds of apnoea is induced after adequate preoxygenation
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- esophagus intubation
- Keywords
- endotracheal intubation, esophageal intubation
- Medical subject headings
- Hypoxia, Hypoventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esophagus intubationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: esophagus intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity/specificity of the fully-automatic device
Determine the sensitivity/specificity of the fully-automatic device to diagnose oesophageal intubation based on test ventilations
Measured: first 3 minutes after intubation
Secondary outcomes (1)
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"
Measured: first 3 minutes of intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study startJan 2015
- Primary completionJan 2015
- Study completionJan 2015
Why it stopped: The PI has left the hopsital
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alain Kalmar, MD PhD, Principal investigator, University hosptal Medical Center Groningen,University of Groningen, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02052869
- Sponsor's protocol ID
- Lazarus 003
- Status last verified
- Apr 2024
- First submitted
- 28 Jan 2014
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spirometric Detection of Esophageal Intubation
- ClinicalTrials.gov ID
- NCT02052869
- Acronym / sponsor ID
- Lazarus 003
- Conditions
- Hypoxia, Hypoventilation
- Keywords
- endotracheal intubation, esophageal intubation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The PI has left the hopsital
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 3 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| esophagus intubation | Other | Procedure: esophagus intubationall 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- Oesophageal pathology
- Patients at risk for desaturation (SpO2 < 95%) if 20 seconds of apnoea is induced after adequate preoxygenation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| esophagus intubationIn 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. | Procedure or surgery | esophagus intubation |
Primary outcome
sensitivity/specificity of the fully-automatic device
Time frame: first 3 minutes after intubation
Determine the sensitivity/specificity of the fully-automatic device to diagnose oesophageal intubation based on test ventilations
1 secondary outcome
Evaluate the value of the supplementary algorithm
Time frame: first 3 minutes of intubation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alain Kalmar, MD PhD principal investigator
University hosptal Medical Center Groningen,University of Groningen, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing esophagus intubation in people with Hypoxia and Hypoventilation, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity/specificity of the fully-automatic device (time frame: first 3 minutes after intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.