Transcutaneous Electrical Nerve Stimulation for Tissues Perfusion

• Sponsor: Assiut University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04069871
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 11.7
• Patients Per Site Per Month: 5.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Function Disorder; Critical Illness; Critical Illness Myopathy	Device: trans-cutaneous electrical nerve stimulation.; Device: Sham TENS	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Effect of Transcutaneous Electrical Nerve Stimulation on Tissue Perfusion for the Critically Ill Patient
• Actual Study Start Date: Oct 15, 2019
• Actual Primary Completion Date: Oct 6, 2020
• Actual Study Completion Date: Oct 6, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: TENS	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 Comparator: Control	Device: Sham TENS; Patients in the control group will receive sham TENS.

Outcome Measures

Primary Outcome Measures

1. tissue perfusion of the lower limb. [5 ICU days]

   capillary refill time

2. Renal perfusion [5 ICU days]

   quantitative assessment of neutrophil gelatinase-associated lipocalin

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut University hospital	Assiut	Asyut Governorate	Egypt	11111

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mostafa Samy Abbas, associate professor of anesthesia, Assiut University
• ClinicalTrials.gov Identifier: NCT04069871
• Other Study ID Numbers: TENS
• First Posted: Aug 28, 2019
• Last Update Posted: Dec 16, 2020
• Last Verified: Dec 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Critical Illness

Study Results

No Results Posted as of Dec 16, 2020