Pulmonary Artery Catheter Waveform InterpretationNCT00138073
Effectiveness of a Computer Application in Improving Pulmonary Artery Catheter Waveform Interpretation
A study testing Web-based waveform interpretation guide in people with Pulmonary Artery Catheter Waveform Interpretation, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Skill with pulmonary artery catheter (PAC) waveform interpretation is inadequate among physicians and nurses. We, the investigators at Massachusetts General Hospital, have developed a web-based computer program to assist physicians and nurses in PAC waveform interpretation. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Artery Catheter Waveform Interpretation
- What is being tested?
- Web-based waveform interpretation guide
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Apr 2012
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Critical care nurses
- House officers rotating through the medical Intensive Care Unit
- Fellows rotating through the medical Intensive Care Unit
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Effectiveness of a Web-Based Computer Application in Improving Pulmonary Artery Catheter Waveform Interpretation Among Nurses and Physicians
Skill with pulmonary artery catheter (PAC) waveform interpretation is inadequate among physicians and nurses. We, the investigators at Massachusetts General Hospital, have developed a web-based computer program to assist physicians and nurses in PAC waveform interpretation. We will study the effectiveness of this program on improving the interpretation of waveforms on a computer-based test.
Read the detailed description
The pulmonary artery catheter (PAC) guides diagnosis and treatment in the intensive care unit (ICU), but studies have shown that physicians and nurses collectively have inadequate skill in interpreting PAC waveforms. We have developed a Web-based application that provides physicians and nurses with rapid access to relevant PAC-related content for use in patient care situations. The application begins with a visual index that assists clinicians in the recognition of both normal and abnormal waveforms and provides waveform-specific links to concise advice on making accurate pressure measurements, troubleshooting system problems, and avoiding complications of catheter use. Initial evaluation will consist of a before-and-after trial to determine whether the application improves test performance in the areas of waveform recognition, accuracy of measurement, and appropriateness of action. Once the resource is in production, we will electronically log usage and survey users to evaluate the extent and effect of actual utilization.
- Being tested
- Web-based waveform interpretation guide
- Keywords
- pulmonary artery catheter, waveform interpretation, computer-based learning, medical education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based waveform interpretation guideDevice
Use of an educational website.
| Study group | Role | What they receive |
|---|---|---|
| Web-based waveform interpretation guide | Experimental | The arm has access to the Web-based waveform interpretation guide. Receives: Device: Web-based waveform interpretation guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on a Computer-based Test on Pulmonary Artery Catheter Waveform Interpretation
The study was terminated before the primary outcome could be measured. None of the participants took the post-intervention test.
Measured: 1 month
Secondary outcomes (1)
Individual and Collective Frequency of Use and Usage Patterns of the Web-based Waveform Interpretation Guide
The study was terminated before the secondary outcome could be measured. Usage data was not collected over the following year.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startDec 2005
- Primary completionApr 2012
- Study completionApr 2012
Why it stopped: The study was terminated because of lack of resources to complete it.
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 Pulmonary Artery Catheter Waveform InterpretationStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaime Chang, MD, Massachusetts General Hospital
- Investigators
- Octo Barnett, MD, Principal investigator, Massachusetts General Hospital/Laboratory of Computer Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00138073
- Sponsor's protocol ID
- 2005-P-001381/1; MGH
- Status last verified
- May 2014
- First submitted
- 26 Aug 2005
- Last updated
- 30 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Web-Based Computer Application in Improving Pulmonary Artery Catheter Waveform Interpretation Among Nurses and Physicians
- ClinicalTrials.gov ID
- NCT00138073
- Acronym / sponsor ID
- 2005-P-001381/1; MGH
- Keywords
- pulmonary artery catheter, waveform interpretation, computer-based learning, medical education
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated because of lack of resources to complete it.
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 30 Aug 2005 (estimated)
- Results
- Posted 30 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Skill with pulmonary artery catheter (PAC) waveform interpretation is inadequate among physicians and nurses. We, the investigators at Massachusetts General Hospital, have developed a web-based computer program to assist physicians and nurses in PAC waveform interpretation. We will study the effectiveness of this program on improving the interpretation of waveforms on a computer-based test.
Detailed description
The pulmonary artery catheter (PAC) guides diagnosis and treatment in the intensive care unit (ICU), but studies have shown that physicians and nurses collectively have inadequate skill in interpreting PAC waveforms. We have developed a Web-based application that provides physicians and nurses with rapid access to relevant PAC-related content for use in patient care situations. The application begins with a visual index that assists clinicians in the recognition of both normal and abnormal waveforms and provides waveform-specific links to concise advice on making accurate pressure measurements, troubleshooting system problems, and avoiding complications of catheter use. Initial evaluation will consist of a before-and-after trial to determine whether the application improves test performance in the areas of waveform recognition, accuracy of measurement, and appropriateness of action. Once the resource is in production, we will electronically log usage and survey users to evaluate the extent and effect of actual utilization.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Web-based waveform interpretation guide | Experimental | Device: Web-based waveform interpretation guideThe arm has access to the Web-based waveform interpretation guide. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Critical care nurses
- House officers rotating through the medical Intensive Care Unit
- Fellows rotating through the medical Intensive Care Unit
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Web-based waveform interpretation guideUse of an educational website. | Device | Web-based waveform interpretation guide |
Primary outcome
Score on a Computer-based Test on Pulmonary Artery Catheter Waveform Interpretation
Time frame: 1 month
The study was terminated before the primary outcome could be measured. None of the participants took the post-intervention test.
1 secondary outcome
Individual and Collective Frequency of Use and Usage Patterns of the Web-based Waveform Interpretation Guide
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Pulmonary Artery Catheter Waveform Interpretation
Recruiting
The Role of Swan-Ganz Catheter in Hemodynamic Resuscitation for Patients With Cardiogenic Shock
Cardiogenic Shock, Pulmonary Artery Catheter Waveform Interpretation
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.
Octo Barnett, MD principal investigator
Massachusetts General Hospital/Laboratory of Computer Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based waveform interpretation guide in people with Pulmonary Artery Catheter Waveform Interpretation, run by Massachusetts General Hospital 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 3 inclusion and 0 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: stopped early, as of the sponsor's last update on 30 Jun 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 30 Jun 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?
Score on a Computer-based Test on Pulmonary Artery Catheter Waveform Interpretation (time frame: 1 month). 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 30 Jun 2014.