Catheters, With or Without MalpositionNCT01655329
Reader Study to Demonstrate That Use of ClearRead Confirm is Superior to the Use Standard AP/PA X-ray Image
An observational study of Catheters, With or Without Malposition and Image Interpretation, Computer Assisted, run by Georgetown University at 1 site in United States.
Trial summary
This is a study to determine whether or not a new type of software is, or is not, of benefit. The software, ClearRead Confirm, is designed to enhance the ability of radiologists to detect tubes, lines and wires that may be placed within a patients chest. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Catheters, With or Without Malposition, Image Interpretation, Computer Assisted
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Feb 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: There are two populations: the radiologists and the cases they will review. For cases, these are sequential cases selected by database search using defined search criteria.
Who may be able to join
- For the radiologists, they must in in active practice of community radiology (non-university sites).
- For the cases, they must be patients who have a tube, line, or wire in their chest. A small number of completely normal bedside chest radiographs will be included.
Who cannot join
- For radiologists: Not in active practice. Working in a university hospital.
- For cases: children. Do not meet image quality criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown University Medical Center, Suite 603, 2115 Wisconsin Ave
Washington D.C., District of Columbia, 20007
About this study
Official title: Reader Study to Demonstrate That Use of ClearRead Confirm is Superior to the Use Standard AP/PA X-ray Image. AP Stands for Antero-Posterior. PA Stands for Postero-anterior.
This is a study to determine whether or not a new type of software is, or is not, of benefit. The software, ClearRead Confirm, is designed to enhance the ability of radiologists to detect tubes, lines and wires that may be placed within a patients chest. These types of devices are commonly used for very sick patients in intensive care units and are also used following surgery and in the treatment of cancer. This study will test radiologist's detection of the tips of these devices comparing the results with standard chest radiographs and the the modified chest radiographs. The primary interest is in the time used to interpret the radiograph. We will determine if there is any change in accuracy of detection.
Read the detailed description
Primary hypothesis: the amount of time used for the interpretation of these radiographs will not change. (null hypothesis)
Secondary hypothesis: there will be no change in the accuracy of the detection of the tips of venous catheters and tubes transiting the esophagus. (null hypothesis)
- Keywords
- Image Processing, tubes, lines, catheters, wires, Bedside, chest, radiographs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Standard chest radiographs | The radiologists will be viewing two groups of chest images. The first group are standard chest radiographs. | |
| Modified chest radiographs | This group of chest radiographs will be presented with the modified image. The modified image is intended to increase the visibility of tubes, lines and wires on chest radiographs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time for Completion of Tasks
Time for completion of tasks of identifying the tips of tubes, lines, and wires. Outlying values are excluded from the calculation of the mean values and standard errors. Outlying values were defined as those more than three standard deviations from the mean time.
Measured: 8 hours
Accuracy in Detecting the Tips of Tubes, Lines, and Wires.
Measurement of accuracy in determining the location of the tips of nasogastric tubes (NG) (various types of nasogastric tubes combined) and of the tips of venous catheters (various types of venous catheters combined), compared to the determination of the expert panel. Measure is the distance from the median location determined by five experts in chest radiology.
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Catheters, With or Without MalpositionStudies 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- Riverain Technologies
- Responsible party
- Principal investigator, Matthew T. Freedman, MD, Georgetown University
- Investigators
- Matthew T Freedman, MD, MBA, Principal investigator, Georgetown UniversityShih-Chung Ben Lo, Ph.D., Study director, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01655329
- Sponsor's protocol ID
- MF 2012-1
- Status last verified
- Jun 2014
- First submitted
- 30 Jul 2012
- Last updated
- 10 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reader Study to Demonstrate That Use of ClearRead Confirm is Superior to the Use Standard AP/PA X-ray Image. AP Stands for Antero-Posterior. PA Stands for Postero-anterior.
- ClinicalTrials.gov ID
- NCT01655329
- Acronym / sponsor ID
- MF 2012-1
- Keywords
- Image Processing, tubes, lines, catheters, wires, Bedside, chest, radiographs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- Riverain Technologies
- Study start
- Aug 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 1 Aug 2012 (estimated)
- Results
- Posted 10 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to determine whether or not a new type of software is, or is not, of benefit. The software, ClearRead Confirm, is designed to enhance the ability of radiologists to detect tubes, lines and wires that may be placed within a patients chest. These types of devices are commonly used for very sick patients in intensive care units and are also used following surgery and in the treatment of cancer. This study will test radiologist's detection of the tips of these devices comparing the results with standard chest radiographs and the the modified chest radiographs. The primary interest is in the time used to interpret the radiograph. We will determine if there is any change in accuracy of detection.
Detailed description
Primary hypothesis: the amount of time used for the interpretation of these radiographs will not change. (null hypothesis)
Secondary hypothesis: there will be no change in the accuracy of the detection of the tips of venous catheters and tubes transiting the esophagus. (null hypothesis)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard chest radiographs | – | –The radiologists will be viewing two groups of chest images. The first group are standard chest radiographs. |
| Modified chest radiographs | – | –This group of chest radiographs will be presented with the modified image. The modified image is intended to increase the visibility of tubes, lines and wires on chest radiographs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- There are two populations: the radiologists and the cases they will review. For cases, these are sequential cases selected by database search using defined search criteria.
Key inclusion criteria (2 listed)
- For the radiologists, they must in in active practice of community radiology (non-university sites).
- For the cases, they must be patients who have a tube, line, or wire in their chest. A small number of completely normal bedside chest radiographs will be included.
Key exclusion criteria (2 listed)
- For radiologists: Not in active practice. Working in a university hospital.
- For cases: children. Do not meet image quality criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time for Completion of Tasks
Time frame: 8 hours
Time for completion of tasks of identifying the tips of tubes, lines, and wires. Outlying values are excluded from the calculation of the mean values and standard errors. Outlying values were defined as those more than three standard deviations from the mean time.
Accuracy in Detecting the Tips of Tubes, Lines, and Wires.
Time frame: 8 hours
Measurement of accuracy in determining the location of the tips of nasogastric tubes (NG) (various types of nasogastric tubes combined) and of the tips of venous catheters (various types of venous catheters combined), compared to the determination of the expert panel. Measure is the distance from the median location determined by five experts in chest radiology.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Catheters, With or Without Malposition
Enrolling by invitationObservational study
Ultrasound Guidance vs. Landmark Technique for Catheter Malposition in IJV Catheterization
Catheter Malposition, Central Venous Catheterization
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.
Matthew T Freedman, MD, MBA principal investigator
Georgetown University
Shih-Chung Ben Lo, Ph.D. study director
Georgetown University
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 Catheters, With or Without Malposition and Image Interpretation, Computer Assisted, run by Georgetown University at 1 site in United States.
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 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 10 Jul 2014. 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 United States. 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?
Yes. Results are posted in the registry (first posted 10 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time for Completion of Tasks (time frame: 8 hours). The study lists 2 primary outcomes in all. 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 10 Jul 2014; AzTrials last refreshed its copy on 31 Oct 2026.