HypotensionNCT01680393
Sequential Compression Device (SCD) for Stabilizing Hemodynamics in the Beach Chair Position
A study testing Sequential compression device and TED stockings in people with Hypotension, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
This study is a 3-legged randomized study examining whether during shoulder surgery performed in the beach chair position active compressions of the lower leg with a sequential compression device (SCD) have a superior effect on stabilizing cerebral and circulatory hemodynamics when compared to TED stockings or a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypotension
- What is being tested?
- Sequential compression device and TED stockings
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- May 2011to Nov 2012
- 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
- adult patients undergoing elective shoulder surgery
Who cannot join
- untreated hypertension
- no pulse in a. dorsalis pedis or a.tibialis posterior
- leg ulcers
- failed scalenous blockade
Trial locations and contacts
1 site in 1 country.
Frank Pott, MD, DMsc contact
Denmark1 site, 1 recruiting
- Recruiting
Bispebjerg Hospital
Copenhagen, Copenhagen N, 2200
Frank Pott, MD, DMsc
About this study
Official title: Stabilizing Cerebral and Circulatory Hemodynamics During Shoulder Surgery in the Beach Chair Position Using Sequential Compression Device (SCD) or TED Stockings Compared to a Control Group
This study is a 3-legged randomized study examining whether during shoulder surgery performed in the beach chair position active compressions of the lower leg with a sequential compression device (SCD) have a superior effect on stabilizing cerebral and circulatory hemodynamics when compared to TED stockings or a control group without any stockings.
Read the detailed description
This study examines whether during shoulder surgery performed in the beach chair position active compressions of the lower leg with a sequential compression device (SCD) have a superior effect on stabilizing cerebral and circulatory hemodynamics when compared to TED stockings or a control group without any stockings.
- Conditions
- Hypotension
- Being tested
- Sequential compression device, TED stockings
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequential compression deviceDevice
Also called SCD express Kendall
a sequential compression device will be applied to the legs
TED stockingsOther
Also called TED compression stockings, Kendall
TED stockings will be applied to the patients legs during surgery
| Study group | Role | What they receive |
|---|---|---|
| Sequential compression device | Experimental | During arthroscopic shoulder surgery, an SCD device will be applied to the patients legs during surgery. Cerebral oxygenation and circulatory parameters will be recorded continuously throughout the surgery. Recordings will be hidden to the primary caregiver. Receives: Device: Sequential compression device |
| TED stockings | Experimental | During arthroscopic shoulder surgery, TED stockings will be applied to the patients legs during surgery. Cerebral oxygenation and circulatory parameters will be recorded continuously throughout the surgery. Recordings will be hidden to the primary caregiver. Receives: Other: TED stockings |
| Control | No intervention | no stockings will be applied to the patients legs |
What is being measured
The primary outcome is the main question the study is designed to answer.
cerebral oxygenation
cerebral oxygenation averaged of 1 min during the operation
Measured: per minute
Secondary outcomes (4)
ephedrine
amount of ephedrine used during surgery
Measured: throughout duration of anaesthesia, approximately 60 minutes
cardiac output
cardiac output averaged over 1 minute during the entire surgery
Measured: per minute
Stroke volume
stroke volume averaged over 1 minute during the entire surgery
Measured: per minute
mean arterial pressure
MAP averaged over 1 minute during the entire surgery
Measured: per minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2012 (estimated)
- Study startMay 2011
- Primary completionNov 2012 (estimated)
- Study completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frank Christian Pott, MD, Bispebjerg Hospital
- Investigators
- Frank Pott, MD,DMsc, Principal investigator, Department of Anesthesiology, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01680393
- Sponsor's protocol ID
- BBH290511BRAINshoulderscd
- Status last verified
- Sep 2012
- First submitted
- 1 Feb 2012
- Last updated
- 7 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stabilizing Cerebral and Circulatory Hemodynamics During Shoulder Surgery in the Beach Chair Position Using Sequential Compression Device (SCD) or TED Stockings Compared to a Control Group
- ClinicalTrials.gov ID
- NCT01680393
- Acronym / sponsor ID
- BBH290511BRAINshoulderscd
- Conditions
- Hypotension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 7 Sep 2012 (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.
This study is a 3-legged randomized study examining whether during shoulder surgery performed in the beach chair position active compressions of the lower leg with a sequential compression device (SCD) have a superior effect on stabilizing cerebral and circulatory hemodynamics when compared to TED stockings or a control group without any stockings.
Detailed description
This study examines whether during shoulder surgery performed in the beach chair position active compressions of the lower leg with a sequential compression device (SCD) have a superior effect on stabilizing cerebral and circulatory hemodynamics when compared to TED stockings or a control group without any stockings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sequential compression device | Experimental | Device: Sequential compression deviceDuring arthroscopic shoulder surgery, an SCD device will be applied to the patients legs during surgery. Cerebral oxygenation and circulatory parameters will be recorded continuously throughout the surgery. Recordings will be hidden to the primary caregiver. |
| TED stockings | Experimental | Other: TED stockingsDuring arthroscopic shoulder surgery, TED stockings will be applied to the patients legs during surgery. Cerebral oxygenation and circulatory parameters will be recorded continuously throughout the surgery. Recordings will be hidden to the primary caregiver. |
| Control | No intervention | –no stockings will be applied to the patients legs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients undergoing elective shoulder surgery
Key exclusion criteria (4 listed)
- untreated hypertension
- no pulse in a. dorsalis pedis or a.tibialis posterior
- leg ulcers
- failed scalenous blockade
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 |
|---|---|---|
| Sequential compression deviceAlso: SCD express Kendalla sequential compression device will be applied to the legs | Device | Sequential compression device |
| TED stockingsAlso: TED compression stockings, KendallTED stockings will be applied to the patients legs during surgery | Other | TED stockings |
Primary outcome
cerebral oxygenation
Time frame: per minute
cerebral oxygenation averaged of 1 min during the operation
4 secondary outcomes
ephedrine
Time frame: throughout duration of anaesthesia, approximately 60 minutes
cardiac output
Time frame: per minute
Stroke volume
Time frame: per minute
mean arterial pressure
Time frame: per minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2012.
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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.
Frank Pott, MD, DMsc contact
Frank Pott, MD,DMsc principal investigator
Department of Anesthesiology, Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sequential compression device and TED stockings in people with Hypotension, run by Bispebjerg Hospital at 1 site in Denmark.
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 4 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: status not confirmed, as of the sponsor's last update on 7 Sep 2012. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frank Pott, MD, DMsc (frank.pott@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cerebral oxygenation (time frame: per minute). 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 7 Sep 2012; AzTrials last refreshed its copy on 30 Oct 2026.