Efficacy of Oxepa Enteral Feeding in LTAC (Long Term Acute Care Hospital) Patients on Chronic Ventilation- a Pilot Study

Not Applicable

• Conditions: Mechanical Ventilation Complication; Dietary Modification; Acute Lung Injury
• Interventions: Other: Oxepa; Other: Jevity 1.5

• Registration Number: NCT02208700
• Lead Sponsor: Grace Hospital, Cleveland, Ohio

Brief Summary

Patients with mechanical ventilation have shown improved weaning rates when enteral tube feeding high in EPA, GLA and antioxidants were fed to patients in the critical care setting.

LTAC Patients on chronic mechanical ventilation will have decreased days an mechanical ventilation, decreased mortality rates and decreased organ failure when fed an enteral product high in EPA, GLA and antioxidants compared to an isotonic high fiber enteral nutrition product.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Status Verified: 2014-08
• Study First Submitted: 2014-08-01
• Study First Submitted QC: 2014-08-01
• Last Update Submitted: 2014-08-01
• Study First Posted: 2014-08-05
• Last Update Posted: 2014-08-05
• Primary Completion: 2015-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

>18 years old with Respiratory failure on mechanical ventilation with failure to wean Diagnosis of ARDS (Acute respiratory Distress Syndrome) Bilateral infiltrates -

Exclusion Criteria

History Of pulmonary fibrosis, Terminal illness/ malignancies, <28 day life expectancy, Hemodialysis, Active bleeding or bleeding disorder: DIC ( Disseminated intravascular Coagulation), Sickle Cell Anemia, Hemophilia Hemorrhagic or ischemic stroke, Liver failure, Head trauma with Glasgow coma scale score of <5, Immunosuppression: WBC(White Blood Cell Count) <5000, HIV positive, use of immunosuppressant drugs, Pregnancy, and Heart Failure with EF(Ejection Fraction) <35%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxepa	Oxepa	Other: Therapeutic nutrition with EPA, GLA and antioxidants.
Jevity 1.5	Jevity 1.5	Other: Jevity 1.5 Complete Balanced Nutrition with Fiber .

Primary Outcome Measures

Name	Time	Method
Length of days on mechanical ventilation	14 days from start of enteral feeding

Trial Locations

Locations (1)

Grace Hospital; 🇺🇸 Cleveland, Ohio, United States