Congestive Heart FailureNCT01128036
Comparison of Different Locations for Pulse Oximetry Probes in Cardiovascular (CV) Patients With Poor Peripheral Perfusion
An observational study of Congestive Heart Failure and Cardiomyopathy, run by Saint Luke's Health System at 1 site in United States.
Trial summary
The purpose of this study is to determine if the forehand location for sensor placement has less episodes of signal dropout than the finger sensor location. In addition, this study will evaluate two finger sensors, which utilize different technology to compare signal quality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure, Cardiomyopathy
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to May 2011
- 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
Study population: Patients admitted to the CICU (Coronary Intensive Coronary Unit) with congestive heart failure or cardiomyopathy
Who may be able to join
- CICU patients with a new diagnosis or history of CHF or cardiomyopathy
- Patients with a medical order for pulse oximetry monitoring
- Age greater than or equal to 18 years of age
- English speaking
- Signs of hypoperfusion
Who cannot join
- CICU patients with an impediment to sensor application
- CICU patients with excessive facial edema
- CICU patients with mechanical ventilation
- CICU patients with intra-aortic balloon pump therapy
- CICU patients with intravenous vasopressor drug administration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Different Locations for Pulse Oximetry Probes in Adult Cardiovascular Patients With Poor Peripheral Perfusion
The purpose of this study is to determine if the forehand location for sensor placement has less episodes of signal dropout than the finger sensor location. In addition, this study will evaluate two finger sensors, which utilize different technology to compare signal quality.
Read the detailed description
A comparison study design will be used to evaluate the signal quality of pulse oximetry sensors placed in two locations: forehand and finger. Each subject will serve as their own control, with measurements of signal quality evaluated at 2 second intervals over a period of one hour. The measurements will be recorded simultaneously with a computer program and laptop computer. Finger and forehand sensors will be applied according to manufacturer's guidelines. An output connection will be made from each pulse oximeter computer unit to a password protected, laptop computer for data downloading. Data will be collected for a 1 hour period at 2 second increments and stored in the hard drive of the laptop. Following completion of data collection, the study sensors will be removed.
- Conditions
- Congestive Heart Failure, Cardiomyopathy
- Keywords
- Congestive Heart failure, Cardiomyopathy
- Medical subject headings
- Heart Failure, Cardiomyopathies
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 |
|---|---|---|
| CHF, cardomyopathy | Patients with signs of poor peripheral perfusion due to cardiomyopathy or congestive heart failure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signal quality loss (dropout rate)
Measured: Every 2 seconds for one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2010 (estimated)
- Study startMay 2010
- Primary completionMay 2011
- Study completionMay 2011
Why it stopped: Terminated due to software issues.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies 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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Luke's Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic - MITG
- Investigators
- Lisa Riggs, MSN, Study director, Saint Luke's HospitalMarci Sportsman, BSN, Principal investigator, Saint Luke's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01128036
- Sponsor's protocol ID
- COVMOPO0054
- Status last verified
- Aug 2011
- First submitted
- 20 May 2010
- Last updated
- 9 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Locations for Pulse Oximetry Probes in Adult Cardiovascular Patients With Poor Peripheral Perfusion
- ClinicalTrials.gov ID
- NCT01128036
- Acronym / sponsor ID
- COVMOPO0054
- Conditions
- Congestive Heart Failure, Cardiomyopathy
- Keywords
- Congestive Heart failure, Cardiomyopathy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Terminated due to software issues.
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Saint Luke's Health SystemUniversity, hospital or other
- Collaborators
- Medtronic - MITG
- Study start
- May 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 21 May 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.
The purpose of this study is to determine if the forehand location for sensor placement has less episodes of signal dropout than the finger sensor location. In addition, this study will evaluate two finger sensors, which utilize different technology to compare signal quality.
Detailed description
A comparison study design will be used to evaluate the signal quality of pulse oximetry sensors placed in two locations: forehand and finger. Each subject will serve as their own control, with measurements of signal quality evaluated at 2 second intervals over a period of one hour. The measurements will be recorded simultaneously with a computer program and laptop computer. Finger and forehand sensors will be applied according to manufacturer's guidelines. An output connection will be made from each pulse oximeter computer unit to a password protected, laptop computer for data downloading. Data will be collected for a 1 hour period at 2 second increments and stored in the hard drive of the laptop. Following completion of data collection, the study sensors will be removed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CHF, cardomyopathy | – | –Patients with signs of poor peripheral perfusion due to cardiomyopathy or congestive heart failure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the CICU (Coronary Intensive Coronary Unit) with congestive heart failure or cardiomyopathy
Key inclusion criteria (5 listed)
- CICU patients with a new diagnosis or history of CHF or cardiomyopathy
- Patients with a medical order for pulse oximetry monitoring
- Age greater than or equal to 18 years of age
- English speaking
- Signs of hypoperfusion
Key exclusion criteria (5 listed)
- CICU patients with an impediment to sensor application
- CICU patients with excessive facial edema
- CICU patients with mechanical ventilation
- CICU patients with intra-aortic balloon pump therapy
- CICU patients with intravenous vasopressor drug administration
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
Signal quality loss (dropout rate)
Time frame: Every 2 seconds for one hour
Results and safety
The study was stopped early (reason given: Terminated due to software issues.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2011.
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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.
Lisa Riggs, MSN study director
Saint Luke's Hospital
Marci Sportsman, BSN principal investigator
Saint Luke's Hospital
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 Congestive Heart Failure and Cardiomyopathy, run by Saint Luke's Health System 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 5 inclusion and 5 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 9 Aug 2011. 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?
The study was stopped early (reason given: Terminated due to software issues.). Results are not available in the source record.
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?
Signal quality loss (dropout rate) (time frame: Every 2 seconds for one hour). 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 9 Aug 2011.