Endotracheal Tube PlacementNCT01237756
Electrical Impedance Tomography for Endotracheal Tube Placement
A study testing measurement of left and right lung ventilation in people with Endotracheal Tube Placement, run by University Hospital Freiburg at 1 site in Germany.
Trial summary
Endobronchial tube misplacement is serious complication during general anesthesia in pediatric patients. Correct placement of the endotracheal tube (ETT) in the trachea is crucial. Several methods have been suggested for determination of correct ETT placement. Read more about this study
- Who is it for?
- Ages 1 week to 10 years
- Conditions the study is for
- Endotracheal Tube Placement
- What is being tested?
- measurement of left and right lung ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2008to May 2010
- 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 1 week to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- written informed consent from the parents
- endotracheal intubation with a standard endotracheal tube
Who cannot join
- refusal of written informed consent
- severe lung diseases
- contraindication for use of electrical impedance tomography
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electrical Impedance Tomography for Endotracheal Tube Placement in Pediatric Patients
Endobronchial tube misplacement is serious complication during general anesthesia in pediatric patients. Correct placement of the endotracheal tube (ETT) in the trachea is crucial. Several methods have been suggested for determination of correct ETT placement. However, to date, auscultation of the left and right lung is the standard of care and the only ubiquitary available method with an error rate of up to 12%. Electrical impedance tomography (EIT) is a new non-invasive method for evaluation of left and right lung ventilation. In this study the investigators investigate the potential role of EIT for proper placement of pediatric endotracheal tubes.
Read the detailed description
Several methods have been suggested for determination of correct ETT placement. These include for example the marker method, the mainstem method or the formula method. However, to date, auscultation of the left and right lung is the standard of care and the only ubiquitary available method with an error rate of up to 12%. Electrical impedance tomography (EIT) is a new non-invasive method for evaluation of left and right lung ventilation. In this study the investigators investigate the potential role of EIT for proper placement of pediatric endotracheal tubes. For this purpose, pediatric patients are routinely intubated for cardiac catheterization using the mainstem method or 3xETT size method. Placement of the ETT is then verified by intraoperative fluoroscopy and lung ventilation is verified by EIT.
- Conditions
- Endotracheal Tube Placement
- Being tested
- measurement of left and right lung ventilation
- Keywords
- pediatric anesthesia, endotracheal tube, electrical impedance tomography, misplacement, endobronchial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurement of left and right lung ventilationDevice
Also called EIT, Draeger
Patients are ventilated after endotracheal tube placement and left and right lung ventilation if determined using electrical impedance tomography
| Study group | Role | What they receive |
|---|---|---|
| pediatric | Experimental | Not described Receives: Device: measurement of left and right lung ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
determination of proper endotracheal tube placement
Measured: endotracheal tube placement is immediately verified after endotracheal intubation with fluoroscopy and electrical impedance tomography during the general anesthesia for cardiac catheterization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2010 (estimated)
- Study startSep 2008
- Primary completionMay 2009
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endotracheal Tube PlacementStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
- Investigators
- Daniel Steinmann, MD, Principal investigator, University Medical Center Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01237756
- Sponsor's protocol ID
- 198/08
- Status last verified
- Jun 2008
- First submitted
- 25 Jan 2010
- Last updated
- 10 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Steinmann D, Stahl CA, Minner J, Schumann S, Loop T, Kirschbaum A, Priebe HJ, Guttmann J. Electrical impedance tomography to confirm correct placement of double-lumen tube: a feasibility study. Br J Anaesth. 2008 Sep;101(3):411-8. doi: 10.1093/bja/aen166. Epub 2008 Jun 17.
PubMed 18559350
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Impedance Tomography for Endotracheal Tube Placement in Pediatric Patients
- ClinicalTrials.gov ID
- NCT01237756
- Acronym / sponsor ID
- 198/08
- Conditions
- Endotracheal Tube Placement
- Keywords
- pediatric anesthesia, endotracheal tube, electrical impedance tomography, misplacement, endobronchial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 10 Nov 2010 (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.
Endobronchial tube misplacement is serious complication during general anesthesia in pediatric patients. Correct placement of the endotracheal tube (ETT) in the trachea is crucial. Several methods have been suggested for determination of correct ETT placement. However, to date, auscultation of the left and right lung is the standard of care and the only ubiquitary available method with an error rate of up to 12%. Electrical impedance tomography (EIT) is a new non-invasive method for evaluation of left and right lung ventilation. In this study the investigators investigate the potential role of EIT for proper placement of pediatric endotracheal tubes.
Detailed description
Several methods have been suggested for determination of correct ETT placement. These include for example the marker method, the mainstem method or the formula method. However, to date, auscultation of the left and right lung is the standard of care and the only ubiquitary available method with an error rate of up to 12%. Electrical impedance tomography (EIT) is a new non-invasive method for evaluation of left and right lung ventilation. In this study the investigators investigate the potential role of EIT for proper placement of pediatric endotracheal tubes. For this purpose, pediatric patients are routinely intubated for cardiac catheterization using the mainstem method or 3xETT size method. Placement of the ETT is then verified by intraoperative fluoroscopy and lung ventilation is verified by EIT.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pediatric | Experimental | Device: measurement of left and right lung ventilation |
Who may qualify
- Ages
- 1 week to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- written informed consent from the parents
- endotracheal intubation with a standard endotracheal tube
Key exclusion criteria (3 listed)
- refusal of written informed consent
- severe lung diseases
- contraindication for use of electrical impedance tomography
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 |
|---|---|---|
| measurement of left and right lung ventilationAlso: EIT, DraegerPatients are ventilated after endotracheal tube placement and left and right lung ventilation if determined using electrical impedance tomography | Device | pediatric |
Primary outcome
determination of proper endotracheal tube placement
Time frame: endotracheal tube placement is immediately verified after endotracheal intubation with fluoroscopy and electrical impedance tomography during the general anesthesia for cardiac catheterization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2010.
- Background: PubMed 18559350Steinmann D, Stahl CA, Minner J, Schumann S, Loop T, Kirschbaum A, Priebe HJ, Guttmann J. Electrical impedance tomography to confirm correct placement of double-lumen tube: a feasibility study. Br J Anaesth. 2008 Sep;101(3):411-8. doi: 10.1093/bja/aen166. Epub 2008 Jun 17.
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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.
Daniel Steinmann, MD principal investigator
University Medical Center Freiburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing measurement of left and right lung ventilation in people with Endotracheal Tube Placement, run by University Hospital Freiburg at 1 site in Germany.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 10 Nov 2010. 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 Germany. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
determination of proper endotracheal tube placement (time frame: endotracheal tube placement is immediately verified after endotracheal intubation with fluoroscopy and electrical impedance tomography during the general anesthesia for cardiac catheterization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01237756, which also lists 1 linked publication.
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 10 Nov 2010.