COVID-19 And Geko Evaluation: The CAGE Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-30

Study Completion Date

2022-11-08

Brief Summary

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The primary objectives of this pilot study protocol are to assess safety and feasibility of using the geko™ device in COVID-19.

Regarding safety to patients, we will measure the rate of adverse events, primarily local site irritation or discomfort. Feasibility will be measured on the basis of recruitment; ability to enroll sufficient number of patients meeting criteria. Protocol adherence will be observed as the ability to deliver the study intervention to the patients randomized to the treatment arm within the prescribed timeline and ability to complete the course of treatment. Additionally, we plan to measure patient outcomes such as ICU admission and death. The findings of this study have the potential to decrease the complications seen in COVID-19 infections.

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Detailed Description

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On March 11, 2020, a global pandemic was declared by the World Health Organization. A novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified as the cause of the COVID-19 pandemic. SARS-CoV-2 infection has quickly become one of the fastest growing and deadliest diseases to surface due to its high death rate and ability to replicate and spread readily from people without symptoms. Recent evidence indicates that critically ill patients with COVID-19 experience a high risk of blood clots. Deep leg vein blood clots can travel to the lungs and cause severe lung failure and death. The geko™ device is a simple device that increases the return of blood flow from the lower legs and potentially decrease the risk of lung blood clots. Investigators believe the geko™ device may have an important benefit in COVID-19 patients by decreasing the risk of lung clots and decrease the risk of respiratory failure which is often the cause of death in COVID-19 patients. In this study, Investigators plan to study the effect of using the geko™ device in COVID-19 patients and measure patient outcomes such as ICU admission and death. The findings of this study have the potential to decrease the complications seen in COVID-19 infections.

Conditions

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial of 20 participants in each arm.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Geko Device

Confirmed Covid-19 positive patients will be randomized to either applying the Geko device arm or the no device arm.

Group Type EXPERIMENTAL

geko T3

Intervention Type DEVICE

The device stimulates the peroneal nerve.It will be applied for the entire duration of ICU stay and replaced once every 24 hours.

No Device

Confirmed Covid-19 positive patients will be randomized to either applying the Geko device arm or the no device arm.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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geko T3

The device stimulates the peroneal nerve.It will be applied for the entire duration of ICU stay and replaced once every 24 hours.

Intervention Type DEVICE

Other Intervention Names

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NMES

Eligibility Criteria

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Inclusion Criteria

* Patients who test positive for Covid-19

Exclusion Criteria

* Patients who are unlikely to be adherent or cannot tolerate the therapy (self-report)
* Prior above or below knee amputation
* A history of prior Deep Venous Thrombosis (DVT) or Venous Thromboembolism (VTE),
* Those patients being treated with full dose therapeutic anticoagulation.
* Patients with pacemakers

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No