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Clinical Trials/NCT02847988
NCT02847988
Unknown
N/A

Facilitating Functional Independence in Patients Receiving Prolonged Mechanical Ventilation

RML Specialty Hospital1 site in 1 country200 target enrollmentJuly 2016
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ConditionsMuscle Weakness

Overview

Phase
N/A
Intervention
Not specified
Conditions
Muscle Weakness
Sponsor
RML Specialty Hospital
Enrollment
200
Locations
1
Primary Endpoint
Time to reach independence in performing functional activity
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The primary aim of this proposal is to test the effectiveness of neuromuscular electrical stimulation (NMES) in improving functional status and muscle function in patients receiving prolonged mechanical ventilation.

Registry
clinicaltrials.gov
Start Date
July 2016
End Date
April 2022
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Amal Jubran

Principal Investigator-Staff Physician

RML Specialty Hospital

Eligibility Criteria

Inclusion Criteria

  • •Duration of mechanical ventilation \>14 days
  • •Sufficiently awake
  • •Able to speak and comprehend English
  • •Willingness to participate

Exclusion Criteria

  • •Cardiopulmonary Instability
  • •Acute-onset neuromuscular disease
  • •Lower-extremity amputee or paresis
  • •Open wound at electrode application points
  • •Pitting edema grade ≥3
  • •Presence of pacemaker, implanted defibrillator, or ventricular-assist device
  • •inability to transfer from sitting to standing before critical illness

Outcomes

Primary Outcomes

Time to reach independence in performing functional activity

Time Frame: Hospital discharge, an expected average stay of 5 weeks

Functional activity as measured by functional activity measurement for the ICU (FSS-ICU)

Secondary Outcomes

  • The percentage of patients who can perform functional activities independently(Hospital discharge, an expected average stay of 5 weeks)

Study Sites (1)

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