Circulatory CollapseNCT02726776
Suspension Syndrome
A study testing Suspension in a harness and Climbing in people with Circulatory Collapse and Circulatory Failure, run by Institute of Mountain Emergency Medicine.
Trial summary
Suspension syndrome refers to a potentially life-threatening condition that can occur in unconscious persons after prolonged suspension in a harness. To date, our understanding of the pathophysiology and appropriate treatment is based primarily on case reports and expert opinion. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Circulatory Collapse, Circulatory Failure, Syncope, Vasovagal, Neurally-Mediated
- What is being tested?
- Suspension in a harness and Climbing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Dec 2015
- 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 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers
- Age 18-50 years
- ASA class 1
- Signed informed consent
Who cannot join
- Age <18 or >50 years
- ASA class >1
- Informed consent not signed
About this study
Suspension syndrome refers to a potentially life-threatening condition that can occur in unconscious persons after prolonged suspension in a harness. To date, our understanding of the pathophysiology and appropriate treatment is based primarily on case reports and expert opinion. The main pathophysiological hypothesis implicates blood pooling in the lower extremity and lack of return via muscle pumping. However, a recent French study could not support this hypothesis. Other mechanisms, such as a central vagal reflex may play a role in the pathophysiology of suspension syndrome. The aim of this study is to better understand the pathophysiological basis of suspension syndrome and to develop practical recommendations for prevention and treatment.
- Conditions
- Circulatory Collapse, Circulatory Failure, Syncope, Vasovagal, Neurally-Mediated, Orthostatic Hypotension
- Being tested
- Suspension in a harness, Climbing
- Medical subject headings
- Shock, Syncope, Vasovagal, Hypotension, Orthostatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suspension in a harnessOther
ClimbingOther
| Study group | Role | What they receive |
|---|---|---|
| Suspension without prior climbing | Experimental | Free Suspension in a harness after baseline measurements and without prior climbing Receives: Other: Suspension in a harness |
| Suspension with prior climbing | Experimental | Free Suspension in a harness after baseline measurements and after climbing in moderate intensity for 10 minutes Receives: Other: Suspension in a harness; Other: Climbing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
Measured: Change from baseline (measurement at minute 0) -> suspension phase (minute 10, timepoint immediately before interruption of suspension phase [max 60 minutes]) -> minute 5 and minute 15 after suspension phase
Blood pressure
Measured: Change from baseline (measurement at minute 0) -> suspension phase (minute 10, timepoint immediately before interruption of suspension phase [max 60 minutes]) -> minute 5 and minute 15 after suspension phase
Secondary outcomes (2)
Change in maximal Diameter of superficial femoral vein
Ultrasound measurement of the Diameter of the superficial femoral vein in millimeters
Measured: Change from baseline (measurement at minute 0) -> suspension phase (minute 10, timepoint immediately before interruption of suspension phase [max 60 minutes]) -> minute 5 and minute 15 after suspension phase
Change in interbeat-interval
electrocardiographic measurement of interbeat interval in milliseconds (ms)
Measured: Change from baseline (measurement at minute 0) -> suspension phase (minute 10, timepoint immediately before interruption of suspension phase [max 60 minutes]) -> minute 5 and minute 15 after suspension phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2016 (estimated)
- Study startSep 2015
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Circulatory CollapseStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Mountain Emergency Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Paal, MD, MBA, Study director, Barts Heart Centre, LondonHermann Brugger, MD, Study director, Eurac, Institute of mountain emergency medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02726776
- Sponsor's protocol ID
- A.10
- Status last verified
- Apr 2016
- First submitted
- 15 Mar 2016
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Pasquier M, Yersin B, Vallotton L, Carron PN. Clinical update: suspension trauma. Wilderness Environ Med. 2011 Jun;22(2):167-71. doi: 10.1016/j.wem.2010.12.006. Epub 2010 Dec 23.
PubMed 21420883Lee C, Porter KM. Suspension trauma. Emerg Med J. 2007 Apr;24(4):237-8. doi: 10.1136/emj.2007.046391.
PubMed 17384373
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suspension Syndrome
- ClinicalTrials.gov ID
- NCT02726776
- Acronym / sponsor ID
- A.10
- Conditions
- Circulatory Collapse, Circulatory Failure, Syncope, Vasovagal, Neurally-Mediated, Orthostatic Hypotension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Institute of Mountain Emergency MedicineUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 4 Apr 2016 (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.
Suspension syndrome refers to a potentially life-threatening condition that can occur in unconscious persons after prolonged suspension in a harness. To date, our understanding of the pathophysiology and appropriate treatment is based primarily on case reports and expert opinion. The main pathophysiological hypothesis implicates blood pooling in the lower extremity and lack of return via muscle pumping. However, a recent French study could not support this hypothesis. Other mechanisms, such as a central vagal reflex may play a role in the pathophysiology of suspension syndrome. The aim of this study is to better understand the pathophysiological basis of suspension syndrome and to develop practical recommendations for prevention and treatment.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suspension without prior climbing | Experimental | Other: Suspension in a harnessFree Suspension in a harness after baseline measurements and without prior climbing |
| Suspension with prior climbing | Experimental | Other: Suspension in a harness, Other: ClimbingFree Suspension in a harness after baseline measurements and after climbing in moderate intensity for 10 minutes |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy volunteers
- Age 18-50 years
- ASA class 1
- Signed informed consent
Key exclusion criteria (3 listed)
- Age <18 or >50 years
- ASA class >1
- Informed consent not signed
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 |
|---|---|---|
| Suspension in a harness | Other | Suspension with prior climbing, Suspension without prior climbing |
| Climbing | Other | Suspension with prior climbing |
Primary outcome
Heart rate
Time frame: Change from baseline (measurement at minute 0) -> suspension phase (minute 10, timepoint immediately before interruption of suspension phase [max 60 minutes]) -> minute 5 and minute 15 after suspension phase
Blood pressure
Time frame: Change from baseline (measurement at minute 0) -> suspension phase (minute 10, timepoint immediately before interruption of suspension phase [max 60 minutes]) -> minute 5 and minute 15 after suspension phase
2 secondary outcomes
Change in maximal Diameter of superficial femoral vein
Time frame: Change from baseline (measurement at minute 0) -> suspension phase (minute 10, timepoint immediately before interruption of suspension phase [max 60 minutes]) -> minute 5 and minute 15 after suspension phase
Change in interbeat-interval
Time frame: Change from baseline (measurement at minute 0) -> suspension phase (minute 10, timepoint immediately before interruption of suspension phase [max 60 minutes]) -> minute 5 and minute 15 after suspension phase
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 6 Apr 2016.
- Results publication: PubMed 21420883Pasquier M, Yersin B, Vallotton L, Carron PN. Clinical update: suspension trauma. Wilderness Environ Med. 2011 Jun;22(2):167-71. doi: 10.1016/j.wem.2010.12.006. Epub 2010 Dec 23.
- Results publication: PubMed 17384373Lee C, Porter KM. Suspension trauma. Emerg Med J. 2007 Apr;24(4):237-8. doi: 10.1136/emj.2007.046391.
- Individual participant dataSharing planned: No
Related trials for Circulatory Collapse
RecruitingObservational study
Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure
Heart Failure, Muscle Atrophy
Recruiting
Routine Versus Provisional Distal Perfusion Catheter Placement in Patients Undergoing Mechanical Circulatory Support
Cardiogenic Shock, Acute Myocardial Infarction of Inferior Wall
RecruitingObservational study
Factors Influencing Outcomes in ECMO and Impella Patients: Metabolic and Thyroid Hormone Dynamics
Cardiogenic Shock, Euthyroid Sick Syndrome
Active, not recruiting
FlexWave Trial: Efficacy of Extracorporeal Shock Wave Therapy in Post-Stroke Upper Limb Spasticity
Stroke, Spasticity, Muscle
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
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.
Peter Paal, MD, MBA study director
Barts Heart Centre, London
Hermann Brugger, MD study director
Eurac, Institute of mountain emergency medicine
Questions about this trial
What is this clinical trial studying?
A study testing Suspension in a harness and Climbing in people with Circulatory Collapse and Circulatory Failure, run by Institute of Mountain Emergency Medicine.
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 4 inclusion and 3 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 6 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Heart rate (time frame: Change from baseline (measurement at minute 0) -> suspension phase (minute 10, timepoint immediately before interruption of suspension phase [max 60 minutes]) -> minute 5 and minute 15 after suspension phase). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02726776, which also lists 2 linked publications.
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 6 Apr 2016.