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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04069871
Other study ID # TENS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 15, 2019
Est. completion date October 6, 2020

Study information

Verified date December 2020
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date October 6, 2020
Est. primary completion date October 6, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Intervention

Device:
trans-cutaneous electrical nerve stimulation.
• Patients assigned to the EMS group received daily EMS sessions of both lower extremities starting from the second day for 5days.
Sham TENS
Patients in the control group will receive sham TENS.

Locations

Country Name City State
Egypt Assiut University hospital Assiut Asyut Governorate

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary tissue perfusion of the lower limb. capillary refill time 5 ICU days
Primary Renal perfusion quantitative assessment of neutrophil gelatinase-associated lipocalin 5 ICU days
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