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| Name | Class |
|---|---|
| Griffith University | OTHER |
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This is a single-centre, open-label, multi-visit study design, in 40 healthy participants, randomized by gauge of peripheral intravenous catheter (PIVC) device into the lower arm cephalic vein of both arms.
The purpose of this study is to assess impact of catheter length and gauge on PIVC indwell time over a 72 hour period. This study will also evaluate the incidence of haemolysis using blood draws from the PIVC.
The study aims to provide preliminary information on the performance of the peripheral intravenous catheter (PIVC) device,
Each participant will complete 6 visits: a Screening Visit (V1), PIVC in situ (V2-V5) and follow-up (V6).
The in-situ catheter positions will be compared to the expected tip position based on the catheter lengths. Blood collected will be analysed for haemolysis.
As both device length and gauge are expected to influence haemolysis the study design enables evaluation of both design features.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Small gauge arm | Other | 2 PIVCs of same gauge (22G) and different lengths |
|
| Large gauge arm | Other | 2 PIVCs of same gauge (20G) and different lengths |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peripheral Intravenous Catheter | Device | Randomised controlled |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patent Indwell Time Between PIVCs of Different Length and Gauge. | Catheter indwell time for each PIVC, expressed in hours | 72 hrs |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Haemolysis Occurrence Based on Blood Collection Device and Catheter Device Configuration | Haemolysis: Frequency of occurrence | 72 hrs |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Griffith University | Gold Coast | Queensland | 4111 | Australia |
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40 enrolled and randomized subjects
| ID | Title | Description |
|---|---|---|
| FG000 | PIVC 22G, 1 Inch Length | One participant receives 2 Peripheral Intravenous Catheters (PIVC) with the same Gauge (22G), one in each arm. The length of the catheter is different in each arm, in this case: 1 Inch. Choice of catheter size and length is randomized per participant, as well as which arm is first catharized. |
| FG001 | PIVC 22G, 1.75 Inch Length | One participant receives 2 Peripheral Intravenous Catheters (PIVC) with the same Gauge (22G), one in each arm. The length of the catheter is different in each arm, in this case: 1.75 Inch. Choice of catheter size and length is randomized per participant, as well as which arm is first catharized. |
| FG002 | PIVC 20G, 1 Inch Length | One participant receives 2 Peripheral Intravenous Catheters (PIVC) with the same Gauge (20G), one in each arm. The length of the catheter is different in each arm, in this case: 1 Inch. Choice of catheter size and length is randomized per participant, as well as which arm is first catharized. |
| FG003 | PIVC 20G, 1.75 Inch Length | One participant receives 2 Peripheral Intravenous Catheters (PIVC) with the same Gauge (20G), one in each arm. The length of the catheter is different in each arm, in this case: 1.75 Inch. Choice of catheter size and length is randomized per participant, as well as which arm is first catharized. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Small Gauge | 2 PIVCs of same gauge (22G) and different lengths Peripheral Intravenous Catheter: Randomised controlled |
| BG001 | Large Gauge | 2 PIVCs of same gauge (20G) and different lengths Peripheral Intravenous Catheter: Randomised controlled |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patent Indwell Time Between PIVCs of Different Length and Gauge. | Catheter indwell time for each PIVC, expressed in hours | After screening and enrollment, participants will be randomized in order of their enrollment to either 20 or 22G of the BD NexivaTM PIVC and order of placement location (left or right arm first). The participant will have both the 1 inch and 1.75 inch PIVCs inserted on Study Day 1 (Visit 2), one into each arm. After successful insertion into the lower cephalic vein of the selected arm, the site will be regularly accessed (twice daily) for phlebotomy and then flushed. | Posted | Mean | Standard Deviation | hours | 72 hrs |
|
Adverse Events are collected from time of enrollment until catheter removal (max 72 hours indwell time)
Adverse Events are systematically collected during the study visits and a Clinical Research Associate actively reviewed the patient medical records for any occurred events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PIVC 22G, 1 Inch Length | Adverse Events are presented for all participants within the group of participants receiving the small gauge catheter of 22G, for 1 Inch catheter length. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombophlebitis | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Rini, Associate Director Translational and Clinical Sciences Center of Excellence | Becton, Dickinson and Company | +1 984 389 1186 | christopher.rini@bd.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 2, 2020 | Dec 28, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 17, 2021 | Dec 28, 2021 | SAP_001.pdf |
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Randomised, controlled
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| Recent use of analgesics | Count of Participants | Participants |
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| Systolic Blood Pressure | Mean | Standard Deviation | mm Hg |
|
| Diastolic Blood Pressure | Mean | Standard Deviation | mm Hg |
|
| O2 saturation | Mean | Standard Deviation | Percentage of oxygen in blood |
|
small gauge, longer catheter |
| OG002 | PIVC 20G, 1 Inch Length | large gauge, smaller catheter |
| OG003 | PIVC 20G, 1.75 Inch Length | large gauge, larger catheter |
|
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| Secondary | Number of Participants With Haemolysis Occurrence Based on Blood Collection Device and Catheter Device Configuration | Haemolysis: Frequency of occurrence | Posted | Count of Units | arms | 72 hrs | arms | arms |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 1 |
| 19 |
| EG001 | PIVC 22G, 1.75 Inch Length | Adverse Events are presented for all participants within the group of participants receiving the large gauge catheter of 22G, for 1.75 Inch catheter length. | 0 | 19 | 0 | 21 | 1 | 19 |
| EG002 | PIVC 20G, 1 Inch Length | Adverse Events are presented for all participants within the group of participants receiving the large gauge catheter of 20G, for 1 Inch catheter length. | 0 | 21 | 0 | 21 | 11 | 21 |
| EG003 | PIVC 20G, 1.75 Inch Length | Adverse Events are presented for all participants within the group of participants receiving the large gauge catheter of 20G, for 1.75 Inch catheter length. | 0 | 21 | 0 | 21 | 8 | 21 |
| Inflammatory pain | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Venous thrombosis | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 23.1 | Systematic Assessment | This AE cannot be attributed to either catheter length - the only thing that is certain is that it happened in the 20G group |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment | This AE cannot be attributed to either catheter length - the only thing that is certain is that it happened in the 20G group |
|
| Injection site extravasation | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Injection site haematoma | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment | This AE cannot be attributed to either catheter length - the only thing that is certain is that it happened in the 20G group |
|
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| Visual haemolysis, 6 mL collection tube |
|