Assessment of Injectable Medication Platforms

NCT ID: NCT05367531

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-30
• Study Completion Date: 2025-01-01

Brief Summary

Background:

While medical advances for in-hospital care rapidly evolve, a mainstay of effective pre-hospital care remains the ability to treat medical emergencies such as anaphylaxis, prolonged seizure, overdose, or uncontrolled bleeding, through rapid administration of appropriate medication. Autoinjectors are used globally to deliver medications in a timely manner, often in environments where immediate access to medical facilities is limited. Rapid administration of intramuscular medication delivery is essential where oral or intravenous delivery is either not possible or ineffective. The purpose of the proposed study seeks to determine the efficiency various types of medication injection administration.

Detailed Description

Research Objective:

To understand the efficiency of injectable medication delivery in the Canadian Forces and civilian world for improved care delivery in military and pre-hospital environments.

Participants:

Approximately thirty (30) participants will be recruited for the study.

Methods:

Data will be obtained on the technical comparison of efficiency for pre-filled syringes to the current standards of administration. The timing and accuracy for administering saline to an inanimate object using the traditional methods versus a pre-filled medication syringes will be compared.

Risks and Risk Mitigation:

The participants in this study are all practicing military personnel who are able to give free and informed consent. To reduce undue influence, LCol Meredith and Dr Gupta will not be involved in recruitment. As a result, these participants are a low vulnerability group. The risk of any adverse events is low since data scenarios, and participants may choose to skip any questions or scenarios that participants do not wish to do. Investigators will remind all participants that their participation is voluntary, and that they may choose to withdraw or stop at any time.

Benefits and Military Significance:

The proposed study will be the first of its kind to assess the efficiency of various injectable medication delivery platforms. This data will provide a background for improving injectable drug delivery practices in various setting (eg military and pre-hospital settings), including the potential to inform novel medical device development.

Conditions

Overdose Antidote; Bleeding; Allergic Reaction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Injection Scenario

For each scenario participants will be asked to administer/inject the "medication" (likely saline or air) using various methods: 1) standard protocol , 2) Autoinjector 3) Pre-filled syringes. For each scenario the appropriate medication administration type will have to be selected amongst groups of options: 1) autoinjectors equivalents (ie medication, needle and syringe attached) 2) prefilled syringes where a needle is attached prior to administration; and 3) standard protocol (i.e. drawing medication from the vial and injecting via syringe/22 gauge needle). Medications options will include 1) Naloxone (opioid overdose) 2) Epinephrine (anaphylaxis) 3) Tranexamic acid (bleeding).

Group Type: EXPERIMENTAL

Autoinjector

Intervention Type: DEVICE

For each scenario the appropriate medication administration type will have to be selected amongst groups of options: 1) autoinjectors equivalents (ie medication, needle and syringe attached) 2) prefilled syringes where a needle is attached prior to administration; and 3) standard protocol (i.e. drawing medication from the vial and injecting via syringe/22 gauge needle). Medications options will include 1) Naloxone (opioid overdose) 2) Epinephrine (anaphylaxis) 3) Tranexamic acid (bleeding).

The order of administration for each scenario and injection type will be randomized to exclude any bias. To minimize risk to participants, active drug products and live/loaded autoinjectors will not be used. The target injection will be placed in an inanimate object (e.g. orange) or phantom simulator (i.e. inanimate object such as a gel or organic material such as jello or fruit to simulate an injection experience).

Standard Injector

Intervention Type: DEVICE

For each scenario the appropriate medication administration type will have to be selected amongst groups of options: 1) autoinjectors equivalents (ie medication, needle and syringe attached) 2) prefilled syringes where a needle is attached prior to administration; and 3) standard protocol (i.e. drawing medication from the vial and injecting via syringe/22 gauge needle). Medications options will include 1) Naloxone (opioid overdose) 2) Epinephrine (anaphylaxis) 3) Tranexamic acid (bleeding).

The order of administration for each scenario and injection type will be randomized to exclude any bias. To minimize risk to participants, active drug products and live/loaded autoinjectors will not be used. The target injection will be placed in an inanimate object (e.g. orange) or phantom simulator (i.e. inanimate object such as a gel or organic material such as jello or fruit to simulate an injection experience).

Prefilled

Intervention Type: DEVICE

For each scenario the appropriate medication administration type will have to be selected amongst groups of options: 1) autoinjectors equivalents (ie medication, needle and syringe attached) 2) prefilled syringes where a needle is attached prior to administration; and 3) standard protocol (i.e. drawing medication from the vial and injecting via syringe/22 gauge needle). Medications options will include 1) Naloxone (opioid overdose) 2) Epinephrine (anaphylaxis) 3) Tranexamic acid (bleeding).

The order of administration for each scenario and injection type will be randomized to exclude any bias. To minimize risk to participants, active drug products and live/loaded autoinjectors will not be used. The target injection will be placed in an inanimate object (e.g. orange) or phantom simulator (i.e. inanimate object such as a gel or organic material such as jello or fruit to simulate an injection experience).

Interventions

Autoinjector

For each scenario the appropriate medication administration type will have to be selected amongst groups of options: 1) autoinjectors equivalents (ie medication, needle and syringe attached) 2) prefilled syringes where a needle is attached prior to administration; and 3) standard protocol (i.e. drawing medication from the vial and injecting via syringe/22 gauge needle). Medications options will include 1) Naloxone (opioid overdose) 2) Epinephrine (anaphylaxis) 3) Tranexamic acid (bleeding).

The order of administration for each scenario and injection type will be randomized to exclude any bias. To minimize risk to participants, active drug products and live/loaded autoinjectors will not be used. The target injection will be placed in an inanimate object (e.g. orange) or phantom simulator (i.e. inanimate object such as a gel or organic material such as jello or fruit to simulate an injection experience).

Intervention Type: DEVICE

Standard Injector

For each scenario the appropriate medication administration type will have to be selected amongst groups of options: 1) autoinjectors equivalents (ie medication, needle and syringe attached) 2) prefilled syringes where a needle is attached prior to administration; and 3) standard protocol (i.e. drawing medication from the vial and injecting via syringe/22 gauge needle). Medications options will include 1) Naloxone (opioid overdose) 2) Epinephrine (anaphylaxis) 3) Tranexamic acid (bleeding).

The order of administration for each scenario and injection type will be randomized to exclude any bias. To minimize risk to participants, active drug products and live/loaded autoinjectors will not be used. The target injection will be placed in an inanimate object (e.g. orange) or phantom simulator (i.e. inanimate object such as a gel or organic material such as jello or fruit to simulate an injection experience).

Intervention Type: DEVICE

Prefilled

For each scenario the appropriate medication administration type will have to be selected amongst groups of options: 1) autoinjectors equivalents (ie medication, needle and syringe attached) 2) prefilled syringes where a needle is attached prior to administration; and 3) standard protocol (i.e. drawing medication from the vial and injecting via syringe/22 gauge needle). Medications options will include 1) Naloxone (opioid overdose) 2) Epinephrine (anaphylaxis) 3) Tranexamic acid (bleeding).

The order of administration for each scenario and injection type will be randomized to exclude any bias. To minimize risk to participants, active drug products and live/loaded autoinjectors will not be used. The target injection will be placed in an inanimate object (e.g. orange) or phantom simulator (i.e. inanimate object such as a gel or organic material such as jello or fruit to simulate an injection experience).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• any participant over the age of 18 able to provide consent

Exclusion Criteria

• only participants with pre specified conditions impacting cognitive and/or manual dexterity will be excluded
• recent substance use
• non health care workers injection with experience with medication injection in last 12 months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Forces Health Services Centre Ottawa

OTHER

Sponsor Role: lead

Responsible Party

Gaurav Gupta

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gaurav Gupta, MD

Role: PRINCIPAL_INVESTIGATOR

CAF

Locations

Canadian Forces

Ottawa, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Gaurav Gupta, MD

Role: CONTACT

gaurav.gupta@forces.gc.ca

6139451601

Sean Meredith, PharmD

Role: CONTACT

SEAN.MEREDITH@forces.gc.ca

6139451601

Facility Contacts

Gaurav Gupta, MD

Role: primary

gaurav.gupta@forces.gc.ca

6139451601

Other Identifiers

2020-046

Identifier Type: -

Identifier Source: org_study_id