EASI Access II --- Follow-up Study to the EASI Access Trial

Massachusetts General Hospital18 enrolled

Overview

Test whether Basic Life Support (BLS) providers can successfully place Enzymatically Augmented Subcutaneous Infusion (EASI) Access lines for subcutaneous infusion, and characterize intravascular absorption of EASI-administered (tracer-labelled) glucose (D5W).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Disaster Medicine Difficult Intravenous Access Dehydration

Interventions

Human recombinant hyaluronidase (HRH)DRUG

150u HRH administered via EASI access line, prior to infusion of 250 D5W (5% dextrose in water)

Enzymatically Augmented Subcutaneous Infusion (EASI) line placementPROCEDURE

Subjects will under placement of an EASI line. This entails placement of a small (20-gauge) catheter in the upper back, in the subcutaneous space.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects will be at least 18 years of age and have none of the following conditions: * pregnancy (negative urine pregnancy test to be performed before study participation), * diabetes, or coagulopathic (including taking any anticoagulants); * Subjects cannot be taking steroids or other immunosuppressants. * Because of the potential for reduced hyaluronidase effectiveness, the study excludes patients taking more than 80 mg daily aspirin, as well as any patients taking ACTH, antihistamines, or estrogen other than in oral contraceptive preparations. * Subjects will not be required to fast before the study, but will not allowed to eat or drink during the EASI infusion or the phlebotomy sampling time frame.

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Number of Participants With Successfully Placed EASI Lines

Ability of Basic Life Support (BLS) providers to place EASI access lines. The unit of analysis is the 18 BLS participants (these were also the 18 individuals in whom the EASI access lines were placed).

Time frame: 1 day

Systemic Absorption of Subcutaneously Administered Tracer-labelled Glucose

Number of subjects (out of a possible 18) in whom EASI-administered tracer-labeled glucose was absorbed systemically.Gas chromatography/Mass spectrometry analysis was performed on timed phlebotomy samples, to assess for tracer-labeled glucose.Isotopic glucose enrichment was determined by plasma analysis on a Hewlett-Packard 5985B quadruple mass spectrometer, using + chemical ionization (methane reagent gas). A 12m×0.20mm ID, OV-1 capillary column (He carrier) was used in the gas chromatograph.Enrichments of glucose were calculated as atom percent excess relative to natural background level.

Time frame: 1 day

Secondary Outcomes

Number of Participants With Pain During EASI Infusion

Assessment during EASI placement \& initial infusion, for pain as assessed with 10-point scale (0=no pain; 10=worst pain). Significant pain was defined a priori as a pain score of at least 3.

Time frame: 1 day

Number of Participants With Pain at EASI Infusion Site, on Next-day Follow-up

Assessment during upon next-day follow-up, for pain as assessed with 10-point scale (0=no pain; 10=worst pain). Significant pain was defined a priori as a pain score of at least 3. Presence of any pain (yes or no question and then numeric rating if pain was present) was assessed upon follow-up by telephone; on this follow-up a yes/no question was also asked about any complications at infusion site (in the upper back).

Time frame: 2 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.