Positive-Pressure Respiration, IntrinsicMDBF-CIPNCT01794468
A New Monitor to Measure Dermal Blood Flow in Critically Ill Patients: a Preliminary Study
A study testing Dermal blood flow measurements in people with Positive-Pressure Respiration, Intrinsic and Critically Ill Patients, run by Rabin Medical Center at 1 site in Israel.
Trial summary
Background: Conditions of reduced perfusion are characterized by redistribution of blood flow away from the skin to more vital organs. Study Objectives: To assess the efficacy of a non-invasive, dermal blood flow (DBF) monitor in detecting changes in perfusion in critically ill patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Positive-Pressure Respiration, Intrinsic, Critically Ill Patients
- What is being tested?
- Dermal blood flow measurements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2003to Jul 2005
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients were ventilated and sedated during an 8-hour period of measurement
Who cannot join
- Age < 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Background: Conditions of reduced perfusion are characterized by redistribution of blood flow away from the skin to more vital organs.
Study Objectives: To assess the efficacy of a non-invasive, dermal blood flow (DBF) monitor in detecting changes in perfusion in critically ill patients.
Preliminary Study
Study Population: critically ill patients in a general ICU
Read the detailed description
DBF, finger plethysmography and invasive mean arterial pressure (MAP) were recorded over an 8-hour period. DBF was measured using the I.S. MedTech DBF monitor, based on the hot-wire principle of thermal balance of a heater cooled by a moving medium, via a skin probe placed on the anterior chest wall. Sensitivity was evaluated by visual inspection during active states, either induced, e.g. fluid administration, or spontaneous, e.g. altered hemodynamics. Specificity was evaluated during stable states (minimal fluctuations of MAP and no active interventions applied or required). Data are expressed in terms of standard deviation (SD) and of the difference (SDD) between the MAP and each of the tested methods.
- Being tested
- Dermal blood flow measurements
- Keywords
- Dermal blood flow, critically ill
- Medical subject headings
- Positive-Pressure Respiration, Intrinsic, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dermal blood flow measurementsOther
Dermal blood flow was measured with the Dermal Blood Flow (DBF) monitor (I.S. MedTech, Israel), which consists of a skin probe and a measuring and control feedback unit.
| Study group | Role | What they receive |
|---|---|---|
| study group-Dermal blood flow measurements | Experimental | Dermal blood flow was measured with the Dermal Blood Flow (DBF) monitor Receives: Other: Dermal blood flow measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dermal blood flow measurements
DBF monitor - non-invasive method for detecting changes in perfusion in critically ill patients.
Measured: over an 8-hour period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2013 (estimated)
- Study startJun 2003
- Primary completionApr 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Positive-Pressure Respiration, IntrinsicStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pierre singer, Rabin Medical Center
- Investigators
- Jonathan Cohen, Professor,MD, Study chair, ICU dep't, Rabin MC,Petah Tikva, IsraelPierre Singer, Professor,MD, Principal investigator, ICU dep't, Rabin MC,Petah Tikva, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01794468
- Sponsor's protocol ID
- 3030
- Acronym
- MDBF-CIP
- Status last verified
- Feb 2013
- First submitted
- 15 Feb 2013
- Last updated
- 18 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Monitor to Measure Dermal Blood Flow in Critically Ill Patients: a Preliminary Study
- ClinicalTrials.gov ID
- NCT01794468
- Acronym / sponsor ID
- MDBF-CIP / 3030
- Keywords
- Dermal blood flow, critically ill
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Jun 2003
- Primary completion
- Apr 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 18 Feb 2013 (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.
Background: Conditions of reduced perfusion are characterized by redistribution of blood flow away from the skin to more vital organs.
Study Objectives: To assess the efficacy of a non-invasive, dermal blood flow (DBF) monitor in detecting changes in perfusion in critically ill patients.
Preliminary Study
Study Population: critically ill patients in a general ICU
Detailed description
DBF, finger plethysmography and invasive mean arterial pressure (MAP) were recorded over an 8-hour period. DBF was measured using the I.S. MedTech DBF monitor, based on the hot-wire principle of thermal balance of a heater cooled by a moving medium, via a skin probe placed on the anterior chest wall. Sensitivity was evaluated by visual inspection during active states, either induced, e.g. fluid administration, or spontaneous, e.g. altered hemodynamics. Specificity was evaluated during stable states (minimal fluctuations of MAP and no active interventions applied or required). Data are expressed in terms of standard deviation (SD) and of the difference (SDD) between the MAP and each of the tested methods.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group-Dermal blood flow measurements | Experimental | Other: Dermal blood flow measurementsDermal blood flow was measured with the Dermal Blood Flow (DBF) monitor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients were ventilated and sedated during an 8-hour period of measurement
Key exclusion criteria (1 listed)
- Age < 18 years old
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 |
|---|---|---|
| Dermal blood flow measurementsDermal blood flow was measured with the Dermal Blood Flow (DBF) monitor (I.S. MedTech, Israel), which consists of a skin probe and a measuring and control feedback unit. | Other | study group-Dermal blood flow measurements |
Primary outcome
Dermal blood flow measurements
Time frame: over an 8-hour period
DBF monitor - non-invasive method for detecting changes in perfusion in critically ill patients.
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 2013.
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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.
Jonathan Cohen, Professor,MD study chair
ICU dep't, Rabin MC,Petah Tikva, Israel
Pierre Singer, Professor,MD principal investigator
ICU dep't, Rabin MC,Petah Tikva, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dermal blood flow measurements in people with Positive-Pressure Respiration, Intrinsic and Critically Ill Patients, run by Rabin Medical Center at 1 site in Israel.
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 1 inclusion and 1 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 2013. 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 Israel. 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?
Dermal blood flow measurements (time frame: over an 8-hour period). 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 18 Feb 2013.