Venous Thrombosis
Conditions
Keywords
Deep Vein Thrombosis, Effects of compression therapy, Peak Flow Velocity
Brief summary
The objective of this clinical study was to demonstrate the performance of the Vasculaire Compression System to increase femoral venous peak velocity (PFV) in healthy subjects. This study was a single-arm, open label, prospective, single-center clinical study.
Detailed description
Venous thromboembolism, e.g. deep vein thrombosis (DVT) and pulmonary embolism, occurs in approximately one in 1,000 persons in the United States annually and results in more than 250,000 hospital admissions annually in the United States. Intermittent pneumatic compression (IPC), which prevents stasis in the lower limbs, has been shown to be a safe and effective method of prophylaxis of DVT in studies comparing the incidence of DVT and pulmonary embolism with and without IPC. IPC devices decrease venous stasis by augmenting the venous blood flow in the lower extremities. Studies have suggested that an important indicator of the effectiveness of an IPC device in preventing DVT is the peak femoral venous velocity augmentation during the compression phase as compared with the decompression phase of the device. IPC devices produced in the early 1980s and 1990s were cumbersome, noisy and required external power sources, making them suitable only for non-ambulatory patients. Furthermore, these devices have been associated with poor compliance in trauma patients in a hospital setting, and the poor compliance was associated with a higher rate of DVT. The aim of this study is to test the hemodynamic performance of a new portable IPC device, the Venous Health Systems' Vasculaire Compression System. This new device is designed to provide patient comfort and convenience of use while providing similar improvement in venous blood flow when compared with existing IPC devices.
Interventions
Subject comparison analysis of femoral venous Peak Flow Velocity at rest and during compression therapy.
Sponsors
Venous Health Systems, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female subjects between 18 years old and 65 years old; * Capable of and willing to lay supine for approximately one hour; * Subjects must provide written informed consent
Exclusion criteria
* History of Deep Vein Thrombosis (DVT) or suspected DVT; * History of vascular disease, e.g. coronary or peripheral artery disease; * History of stroke; * History of pulmonary edema; * History of congestive heart failure; * Diabetes mellitus; * Past or present smoker; * Surgery or trauma to the right leg within the last six months; * Open ulcers or wounds on the right leg; * Pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Femoral Venous Peak Flow Velocity Compared to Resting Baseline | 3 measurements/10 min. therapy | The femoral vein in the mid-thigh area was located and the femoral venous Peak Flow Velocity (PFV)was measured using duplex ultrasound during the compression phase of treatment. PFV is the maximum velocity of blood flow achieved when the foot and calf compression is applied. The PFV was then compared to the subject's own baseline PFV using a paired t-test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFV Percent Augmentation | 3 measurements/10 minute therapy | Peak Flow Velocity (PFV) from the compression phase subtracted from the PFV from the decompression phase divided by the PFV from the decompression phase expressed as the percent augmentation. |
| Subject Comfort | 10 min therapy | Subject comfort was measured on a scale 1 to 5 (1=negative response; 5=positive response) during the sleeve installation, during use, and completion. |
Countries
United States
Participant flow
Recruitment details
Study Duration: 4 days First subject enrolled: August 31, 2010 Last subject completed: September 3, 2010
Pre-assignment details
No enrolled participants were excluded from the study.
Participants by arm
| Arm | Count |
|---|---|
| Pneumatic Compression Therapy The Vasculaire System provided compression therapy to the foot and calf of the participant's right leg. The system compressed and released the foot and calf to increase blood flow and circulation of the participant's right limb. Ten cycles of compression therapy was applied. Increase in blood flow rate was measured in the participants femoral vein using duplex ultrasonography. | 33 |
| Total | 33 |
Baseline characteristics
| Characteristic | Pneumatic Compression Therapy |
|---|---|
| Age, Categorical <=18 years | 0 Participants 0 |
| Age, Categorical >=65 years | 0 Participants 0 |
| Age, Categorical Between 18 and 65 years | 33 Participants 5.2 |
| Age Continuous | 35 years STANDARD_DEVIATION 11 |
| Region of Enrollment United States | 33 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 33 |
| serious Total, serious adverse events | 0 / 33 |
Outcome results
Primary
Change in Femoral Venous Peak Flow Velocity Compared to Resting Baseline
The femoral vein in the mid-thigh area was located and the femoral venous Peak Flow Velocity (PFV)was measured using duplex ultrasound during the compression phase of treatment. PFV is the maximum velocity of blood flow achieved when the foot and calf compression is applied. The PFV was then compared to the subject's own baseline PFV using a paired t-test.
Time frame: 3 measurements/10 min. therapy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pneumatic Compression Therapy | Change in Femoral Venous Peak Flow Velocity Compared to Resting Baseline | 18.9 cm/s |
Comparison: The femoral venous peak flow velocity (PFV) compared to the subject's own resting baseline PFV.p-value: <0.000195% CI: [16.3, 21.59]t-test, 1 sided
Secondary
PFV Percent Augmentation
Peak Flow Velocity (PFV) from the compression phase subtracted from the PFV from the decompression phase divided by the PFV from the decompression phase expressed as the percent augmentation.
Time frame: 3 measurements/10 minute therapy
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pneumatic Compression Therapy | PFV Percent Augmentation | PFV Percent Augmentation | 175.5 percentages | Standard Deviation 71.7 |
Secondary
Subject Comfort
Subject comfort was measured on a scale 1 to 5 (1=negative response; 5=positive response) during the sleeve installation, during use, and completion.
Time frame: 10 min therapy
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pneumatic Compression Therapy | Subject Comfort | Comfort during installation | 4.94 Units on a Scale | Standard Deviation 0.24 |
| Pneumatic Compression Therapy | Subject Comfort | Comfort during use | 4.94 Units on a Scale | Standard Deviation 0.24 |
| Pneumatic Compression Therapy | Subject Comfort | Comfort after completion | 5.00 Units on a Scale | Standard Deviation 0 |