Double-Lumen Tube PlacementNCT00486616
Examination of Double-Lumen Tube Placement by Functional Electrical Impedance Tomography
An observational study of Double-Lumen Tube Placement and One-Lung Ventilation, run by University Hospital Freiburg at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether functional electrical impedance tomography is suitable for examination of double-lumen tube placement compared with fibreoptic evaluation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Double-Lumen Tube Placement, One-Lung Ventilation
- What is being tested?
- electrical impedance tomography and double-lumen tube placement
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- May 2007to Aug 2007
- Phase
- Observational
- 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
- consent of the patient
- intubation with left- or right-sided double-lumen tube
- age >= 18 years
Who cannot join
- refusal by the patient
- contraindications for EIT-measurement (e.g. pacemaker, pregnancy)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examination of Double-Lumen Tube Placement: Functional Electrical Impedance Tomography Versus Fibreoptic Bronchoscopy
The purpose of this study is to determine whether functional electrical impedance tomography is suitable for examination of double-lumen tube placement compared with fibreoptic evaluation.
- Conditions
- Double-Lumen Tube Placement, One-Lung Ventilation
- Being tested
- electrical impedance tomography, double-lumen tube placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrical impedance tomographyDevice
double-lumen tube placementProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2007 (estimated)
- Study startMay 2007
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Double-Lumen 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
- Observational
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
- Investigators
- Daniel Steinmann, MD, Principal investigator, Department of Anesthesia and Critical Care Medicine, University Hospital Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00486616
- Sponsor's protocol ID
- 117/07
- Status last verified
- Aug 2007
- First submitted
- 13 Jun 2007
- Last updated
- 18 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Double-Lumen Tube Placement: Functional Electrical Impedance Tomography Versus Fibreoptic Bronchoscopy
- ClinicalTrials.gov ID
- NCT00486616
- Acronym / sponsor ID
- 117/07
- Conditions
- Double-Lumen Tube Placement, One-Lung Ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 14 Jun 2007 (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.
The purpose of this study is to determine whether functional electrical impedance tomography is suitable for examination of double-lumen tube placement compared with fibreoptic evaluation.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- consent of the patient
- intubation with left- or right-sided double-lumen tube
- age >= 18 years
Key exclusion criteria (2 listed)
- refusal by the patient
- contraindications for EIT-measurement (e.g. pacemaker, pregnancy)
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 |
|---|---|---|
| electrical impedance tomography | Device | – |
| double-lumen tube placement | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 18 Feb 2008.
Related trials for Double-Lumen Tube Placement
Not yet recruiting
Video-guided Versus Conventional Right-sided Double-lumen Tube Placement for Thoracoscopic Surgery
Right-sided Double-lumen Tube Positioning, Lung Isolation During Thoracoscopic Surgery
RecruitingObservational study
Ultrasound vs. Auscultation and Fiberoptic Bronchoscopy for Double-Lumen Tube Placement
Thoracic Surgery With One-lung Ventilation
Recruiting
C-MAC Blade D Video Vs Macintosh Laryngoscope for Double Lumen Tube Insertion
Video Laryngoscope, Double Lumen Tube Intubation
Not yet recruiting
Videolaryngoscopy vs Direct Laryngoscopy for Double Lumen Tube Lumen Tube Placement - A Multicentre Randomized-controlled Trial (VOLCANO Study)
One Lung Ventilation, Intubation Complication
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
Department of Anesthesia and Critical Care Medicine, University Hospital Freiburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Double-Lumen Tube Placement and One-Lung Ventilation, 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 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: finished, as of the sponsor's last update on 18 Feb 2008. 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.
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 18 Feb 2008.