NCT02726776

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 4, 2016

Completed
Last Updated

April 6, 2016

Status Verified

April 1, 2016

Enrollment Period

2 months

First QC Date

March 15, 2016

Last Update Submit

April 5, 2016

Conditions

Circulatory CollapseCirculatory FailureSyncope, Vasovagal, Neurally-MediatedOrthostatic Hypotension

Outcome Measures

Primary Outcomes (2)

  • Heart rate

    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

    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

    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

    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

Study Arms (2)

Suspension without prior climbing

EXPERIMENTAL

Free Suspension in a harness after baseline measurements and without prior climbing

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

Other: Suspension in a harnessOther: Climbing

Interventions

Suspension in a harnessOTHER
Suspension with prior climbingSuspension without prior climbing
ClimbingOTHER
Suspension with prior climbing

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers
  • Age 18-50 years
  • ASA class 1
  • Signed informed consent

You may not qualify if:

  • Age \<18 or \>50 years
  • ASA class \>1
  • Informed consent not signed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 21420883RESULT

  • Lee C, Porter KM. Suspension trauma. Emerg Med J. 2007 Apr;24(4):237-8. doi: 10.1136/emj.2007.046391.

    PMID: 17384373RESULT

MeSH Terms

Conditions

ShockSyncope, VasovagalHypotension, Orthostatic

Interventions

SuspensionsStair Climbing

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsOrthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesSyncopeUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsHypotensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ColloidsComplex MixturesDosage FormsPharmaceutical PreparationsWalkingLocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Peter Paal, MD, MBA

    Barts Heart Centre, London

    STUDY DIRECTOR

  • Hermann Brugger, MD

    Eurac, Institute of mountain emergency medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2016

First Posted

April 4, 2016

Study Start

September 1, 2015

Primary Completion

November 1, 2015

Study Completion

December 1, 2015

Last Updated

April 6, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Study Protocol Access
Informed Consent Form Access