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Clinical Trials/NCT01785251
NCT01785251
Completed
Not Applicable

Haemodynamic Performance of Neuromuscular Electrical Stimulation (NMES) During Recovery From Total Hip Arthroplasty

National University of Ireland, Galway, Ireland1 site in 1 country11 target enrollmentJune 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Deep Vein Thrombosis
Sponsor
National University of Ireland, Galway, Ireland
Enrollment
11
Locations
1
Primary Endpoint
Lower limb haemodynamic performance
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

Patients post total hip arthroplasty (THA) remain at high risk of developing Deep Vein Thrombosis (DVT) during the recovery period following surgery despite the availability of effective pharmacological and mechanical prophylactic methods. The use of calf muscle neuromuscular electrical stimulation (NMES) during the hospitalised recovery period on this patient group may be effective at preventing DVT. However, the haemodynamic effectiveness and comfort characteristics of NMES in post-THA patients immediately following surgery have yet to be established.

The main objectives are:

  1. To establish if patients in the early post-operative period have tolerance for NMES.
  2. To determine if applying NMES to patients immediately post-THA increases venous outflow from the lower limb over resting conditions.
Registry
clinicaltrials.gov
Start Date
June 2011
End Date
February 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gearoid O Laighin

Professor

National University of Ireland, Galway, Ireland

Eligibility Criteria

Inclusion Criteria

  • Patients who underwent total hip arthroplasty the previous day

Exclusion Criteria

  • Patients with Diabetes Mellitus
  • Patients with Peripheral Vascular Disease
  • Patients currently involved in another trial
  • Previous diagnosis of DVT

Outcomes

Primary Outcomes

Lower limb haemodynamic performance

Time Frame: 4 hours

Duplex Doppler ultrasound will be used as the outcome measure. Both legs will be measured for hemodynamic performance in the popliteal vein by placing the probe at the popliteal fossa. Measurements of peak venous velocity (cm/s), popliteal vein diameter (cm), time averaged mean velocity (TAMEAN, cm/s) and volume flow (ml/min) will be recorded. Doppler measurements will be taken initially at rest, before the application of NMES and once again when the NMES session had commenced.

Secondary Outcomes

  • Patient comfort during application of NMES(4 hours)

Study Sites (1)

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