Back to resultsTranscutaneous Electrical Nerve Stimulation for Tissues Perfusion
Primary Purpose
Renal Function Disorder, Critical Illness, Critical Illness Myopathy
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
trans-cutaneous electrical nerve stimulation.
Sham TENS
Sponsored by
About this trial
This is an interventional supportive care trial for Renal Function Disorder
Eligibility Criteria
Inclusion Criteria:
- Recently intubated patient.
- Adult and both gender.
- Hemodynamic stability
Exclusion Criteria:
- Vascular diseases
- Diabetic patients
- Patients who receive vasoactive drugs
- Patients with varicose vein
- Systemic scoliosis
Sites / Locations
- Assiut University hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
TENS
Control
Arm Description
Outcomes
Primary Outcome Measures
tissue perfusion of the lower limb.
capillary refill time
Renal perfusion
quantitative assessment of neutrophil gelatinase-associated lipocalin
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04069871
Brief Title
Transcutaneous Electrical Nerve Stimulation for Tissues Perfusion
Official Title
Effect of Transcutaneous Electrical Nerve Stimulation on Tissue Perfusion for the Critically Ill Patient
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
October 6, 2020 (Actual)
Study Completion Date
October 6, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of this study is to determine the effect of transcutaneous electrical nerve stimulation in mechanically ventilated patients on the lower limb and renal tissue perfusion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Function Disorder, Critical Illness, Critical Illness Myopathy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TENS
Arm Type
Active Comparator
Arm Title
Control
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
trans-cutaneous electrical nerve stimulation.
Intervention Description
• Patients assigned to the EMS group received daily EMS sessions of both lower extremities starting from the second day for 5days.
Intervention Type
Device
Intervention Name(s)
Sham TENS
Intervention Description
Patients in the control group will receive sham TENS.
Primary Outcome Measure Information:
Title
tissue perfusion of the lower limb.
Description
capillary refill time
Time Frame
5 ICU days
Title
Renal perfusion
Description
quantitative assessment of neutrophil gelatinase-associated lipocalin
Time Frame
5 ICU days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Recently intubated patient.
Adult and both gender.
Hemodynamic stability
Exclusion Criteria:
Vascular diseases
Diabetic patients
Patients who receive vasoactive drugs
Patients with varicose vein
Systemic scoliosis
Facility Information:
Facility Name
Assiut University hospital
City
Assiut
State/Province
Asyut Governorate
ZIP/Postal Code
11111
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Transcutaneous Electrical Nerve Stimulation for Tissues Perfusion
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