NCT04069871

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

October 15, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2020

Completed
Last Updated

December 16, 2020

Status Verified

December 1, 2020

Enrollment Period

12 months

First QC Date

August 23, 2019

Last Update Submit

December 11, 2020

Conditions

Renal Function DisorderCritical IllnessCritical Illness Myopathy

Outcome Measures

Primary Outcomes (2)

  • tissue perfusion of the lower limb.

    capillary refill time

    5 ICU days

  • Renal perfusion

    quantitative assessment of neutrophil gelatinase-associated lipocalin

    5 ICU days

Study Arms (2)

TENS

ACTIVE COMPARATOR
Device: trans-cutaneous electrical nerve stimulation.

Control

SHAM COMPARATOR
Device: Sham TENS

Interventions

trans-cutaneous electrical nerve stimulation.DEVICE

• Patients assigned to the EMS group received daily EMS sessions of both lower extremities starting from the second day for 5days.

TENS
Sham TENSDEVICE

Patients in the control group will receive sham TENS.

Control

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Recently intubated patient.
  • Adult and both gender.
  • Hemodynamic stability

You may not qualify if:

  • Vascular diseases
  • Diabetic patients
  • Patients who receive vasoactive drugs
  • Patients with varicose vein
  • Systemic scoliosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University hospital

Asyut, Asyut Governorate, 11111, Egypt

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor of anesthesia

Study Record Dates

First Submitted

August 23, 2019

First Posted

August 28, 2019

Study Start

October 15, 2019

Primary Completion

October 6, 2020

Study Completion

October 6, 2020

Last Updated

December 16, 2020

Record last verified: 2020-12

Locations

EG(1)