HypoxiaNCT01279746
The Diagnosis of Occult Deep Vein Thrombosis of the Lower Extremities in Patients Presenting With Hypoxia
An observational study of Hypoxia, run by HaEmek Medical Center, Israel at 3 sites in Israel.
Trial summary
The purpose of this study is to prove that bedside Ultrasound Compression is a useful screening tool for the diagnosis of occult deep vein thrombosis in patients presenting to the emergency room with hypoxia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxia
- What is being tested?
- Ultrasound compression of femoral and popliteal veins
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 3 sitesIsrael
- Study dates
- Apr 2010to Jan 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 with saturation under 94% room air
Who may be able to join
- Patients presenting to the Emergency room
- 18 years or older, saturation 94% and under on room air.
Who cannot join
- none
Trial locations and contacts
3 sites in 1 country.
Israel3 sites
HaEmek Medical Center
Afula, Israel
HaEmek Medical Center
Afula, 13425
HaEmek Medical Center
Afula
About this study
The purpose of this study is to prove that bedside Ultrasound Compression is a useful screening tool for the diagnosis of occult deep vein thrombosis in patients presenting to the emergency room with hypoxia.
Read the detailed description
It is known that 30% of deep vein thrombosis of the extremities is belived to be the precedend of pulmonary emboli; an often fatal disease. It is known that DVT (deep vein thrombosis is often occult.
It is also known that pulmonary embolism is often difficult to diagnose and is often missed especialy in patients with chronic illnesses such as COPD and CHF.
Venous compression ultrsound is an exam that can be preformed bedside. It is preformed by placing a vascular ultrasound transducer on the femoral vein and popliteal and checking its compressibility. If DVT is present in the femoral or popliteal veins the veins will be noncompressible. It has been shown that US compression for DVT can be preformed by physicians in the ER with accuracy and speed.
Presently US compression is not a tool used for detection of occult DVT in the ER. I wish to explore the usefullness of compression US of the lower extremities as a screening tool for DVT In the hypoxic patient.
- Conditions
- Hypoxia
- Being tested
- Ultrasound compression of femoral and popliteal veins
- Keywords
- DVT Ultrasound compression Hypoxia Pulmonary Emboli, Occult DVT in hypoxic patients
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound compression of femoral and popliteal veinsDevice
Bedside ultrasound compression of femoral and popliteal veins.
| Study group | Role | What they receive |
|---|---|---|
| ultrasond compression of deep veins | Not described Receives: Device: Ultrasound compression of femoral and popliteal veins |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2011 (estimated)
- Study startApr 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01279746
- Sponsor's protocol ID
- 0003-10-EMC
- Status last verified
- Jun 2015
- First submitted
- 23 Nov 2010
- Last updated
- 23 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnosis of Occult Deep Vein Thrombosis of the Lower Extremities in Patients Presenting With Hypoxia
- ClinicalTrials.gov ID
- NCT01279746
- Acronym / sponsor ID
- 0003-10-EMC
- Conditions
- Hypoxia
- Keywords
- DVT Ultrasound compression Hypoxia Pulmonary Emboli, Occult DVT in hypoxic patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 19 Jan 2011 (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 prove that bedside Ultrasound Compression is a useful screening tool for the diagnosis of occult deep vein thrombosis in patients presenting to the emergency room with hypoxia.
Detailed description
It is known that 30% of deep vein thrombosis of the extremities is belived to be the precedend of pulmonary emboli; an often fatal disease. It is known that DVT (deep vein thrombosis is often occult.
It is also known that pulmonary embolism is often difficult to diagnose and is often missed especialy in patients with chronic illnesses such as COPD and CHF.
Venous compression ultrsound is an exam that can be preformed bedside. It is preformed by placing a vascular ultrasound transducer on the femoral vein and popliteal and checking its compressibility. If DVT is present in the femoral or popliteal veins the veins will be noncompressible. It has been shown that US compression for DVT can be preformed by physicians in the ER with accuracy and speed.
Presently US compression is not a tool used for detection of occult DVT in the ER. I wish to explore the usefullness of compression US of the lower extremities as a screening tool for DVT In the hypoxic patient.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ultrasond compression of deep veins | – | Device: Ultrasound compression of femoral and popliteal veins |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with saturation under 94% room air
Key inclusion criteria (2 listed)
- Patients presenting to the Emergency room
- 18 years or older, saturation 94% and under on room air.
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Ultrasound compression of femoral and popliteal veinsBedside ultrasound compression of femoral and popliteal veins. | Device | ultrasond compression of deep veins |
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 23 Jun 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxia, run by HaEmek Medical Center, Israel at 3 sites 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 2 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 23 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
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 23 Jun 2015.