Suspension Syndrome

• Sponsor: Institute of Mountain Emergency Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT02726776
• Collaborator: (none)
• Enrollment: 20
• Arms: 2
• Duration (Months): 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Circulatory Collapse; Circulatory Failure; Syncope, Vasovagal, Neurally-Mediated; Orthostatic Hypotension	Other: Suspension in a harness; Other: Climbing	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Suspension Syndrome
• Study Start Date: Sep 1, 2015
• Actual Primary Completion Date: Nov 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Suspension without prior climbing Free Suspension in a harness after baseline measurements and without prior climbing	Other: Suspension in a harness
Experimental: Suspension with prior climbing Free Suspension in a harness after baseline measurements and after climbing in moderate intensity for 10 minutes	Other: Suspension in a harness; Other: Climbing

Outcome Measures

Primary Outcome Measures

1. 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]

2. 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 Outcome Measures

1. 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]

   Ultrasound measurement of the Diameter of the superficial femoral vein in millimeters

2. 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]

   electrocardiographic measurement of interbeat interval in milliseconds (ms)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy volunteers

• Age 18-50 years

• ASA class 1

• Signed informed consent

Exclusion Criteria:

• Age <18 or >50 years

• ASA class >1

• Informed consent not signed

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Institute of Mountain Emergency Medicine

Investigators

• Study Director: Peter Paal, MD, MBA, Barts Heart Centre, London
• Study Director: Hermann Brugger, MD, Eurac, Institute of mountain emergency medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institute of Mountain Emergency Medicine
• ClinicalTrials.gov Identifier: NCT02726776
• Other Study ID Numbers: A.10
• First Posted: Apr 4, 2016
• Last Update Posted: Apr 6, 2016
• Last Verified: Apr 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Syncope; Hypotension, Orthostatic; Syncope, Vasovagal; Hypotension; Shock

Study Results

No Results Posted as of Apr 6, 2016