Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06547294
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
Does a Novel Needle Over Catheter Device Improve First Pass Success and Decrease Complications
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Procedural and Post-Procedural Clinical Performance of a Novel Peripheral Intravenous Needle Over Catheter Device OspreyTM
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Emergency Department Patients who were to get intravenous IV access through routine medical care will receive it through trademarked catheter via convenience sample Patient and clinician experience including adverse events will be recorded A standardized data entry sheet will be collected at time of enrollment and then daily thereafter while the subject has the IV The data collected will remain anonymous
Detailed Description:
Identification of Subjects
The emergency department is a designated participating unit providing subjects with medical care that are anticipated to be placed in the observation unit or admitted to an inpatient unit Subjects who meet inclusion criteria will be consented to be included in the study
Assignment of Subject Identification Number
A unique identification number will be given to study subjects Subject numbers will be assigned in sequential order The subject number will consist of 6 characters The first three characters will designate the manufacturer-specific protocol number SVI The last three characters will designate the subject by number in sequential order
Informed Consent
The nurse trained in placing this device will first consent the patient with written forms provided All protocol nurses trained in this device will also have completed CITI training courses per our institutional guidelines
Treatment Assignment
Within this single arm study subjects will be assigned to the study in a single treatment group All patients in the convenience sample who would have received a standard stocked intravenous catheter will instead receive an Osprey catheter provided by the manufacturer They will be compared against historical controls Historical controls will be collected from a review of relevant literature which has been determined to be stable across time and region
Data Collection Method A Case Report Form CRF will be utilized to collect insertion related study data The CRF will not include any patient identifying information such as name or medical identification number The subjects demographic age race and gender baseline information comorbidities type of medicationsfluids delivered will be documented from already captured Epic documentation
A second Case Report Form CRF will be utilized to collect device performance study data The CRF will not include any patient identifying information such as name or medical identification number Device condition ability to flush and obtain a blood return Site condition presence of redness edema drainage patient response level of pain and dwell time will be extracted from Epic as this is the current standard practice to do so
Active patients in the study will be maintained in a file on a secure drive that study personnel have to refer to to follow up active patients Once active patients are no longer being followed daily their name will be removed from that file CRF forms will be filled out by hand and secured in a locked box The data from both CRFs will be transcribed into a digital worksheet ie Microsoft Excel which will be stored on a secured network drive maintained by the hospital
Study Procedure Subjects will be admitted into the study according to the aforementioned criteria
Hospital protocols will be followed for placement of the PIV The site will be marked with date time and initials of inserter During and immediately after the IV placement procedure the CRF will be initiated by staff associated with this study If unsuccessful with first attempt at PIV placement an attempt at another site with the same technique and device will be performed This will be repeated according to facility policy and procedure until a successful PIV is in place or the physician decides to use an alternative therapy that no longer requires peripheral access All catheters will be stabilized using the same form of stabilization device for uniformity in securement procedure throughout the duration of the study
Daily assessments will occur per facility policy and procedure An assessment will include any level of pain andor tenderness presence of erythema edema induration leakage of fluid or purulent drainage from the puncture site catheter dysfunction eg resistance when flushing absence of a blood return Daily assessment will continue until the device is removed completion of therapy or discharge Once all the required data is collected all de-identified data will be entered as a data set into the post procedure CRF for managementanalysis The final paper CRF will be placed in a study folder and maintained for record keeping and data analysis
The emergency department is a designated participating unit providing subjects with medical care that are anticipated to be placed in the observation unit or admitted to an inpatient unit Subjects who meet inclusion criteria will be consented to be included in the study
Assignment of Subject Identification Number
A unique identification number will be given to study subjects Subject numbers will be assigned in sequential order The subject number will consist of 6 characters The first three characters will designate the manufacturer-specific protocol number SVI The last three characters will designate the subject by number in sequential order
Informed Consent
The nurse trained in placing this device will first consent the patient with written forms provided All protocol nurses trained in this device will also have completed CITI training courses per our institutional guidelines
Treatment Assignment
Within this single arm study subjects will be assigned to the study in a single treatment group All patients in the convenience sample who would have received a standard stocked intravenous catheter will instead receive an Osprey catheter provided by the manufacturer They will be compared against historical controls Historical controls will be collected from a review of relevant literature which has been determined to be stable across time and region
Data Collection Method A Case Report Form CRF will be utilized to collect insertion related study data The CRF will not include any patient identifying information such as name or medical identification number The subjects demographic age race and gender baseline information comorbidities type of medicationsfluids delivered will be documented from already captured Epic documentation
A second Case Report Form CRF will be utilized to collect device performance study data The CRF will not include any patient identifying information such as name or medical identification number Device condition ability to flush and obtain a blood return Site condition presence of redness edema drainage patient response level of pain and dwell time will be extracted from Epic as this is the current standard practice to do so
Active patients in the study will be maintained in a file on a secure drive that study personnel have to refer to to follow up active patients Once active patients are no longer being followed daily their name will be removed from that file CRF forms will be filled out by hand and secured in a locked box The data from both CRFs will be transcribed into a digital worksheet ie Microsoft Excel which will be stored on a secured network drive maintained by the hospital
Study Procedure Subjects will be admitted into the study according to the aforementioned criteria
Hospital protocols will be followed for placement of the PIV The site will be marked with date time and initials of inserter During and immediately after the IV placement procedure the CRF will be initiated by staff associated with this study If unsuccessful with first attempt at PIV placement an attempt at another site with the same technique and device will be performed This will be repeated according to facility policy and procedure until a successful PIV is in place or the physician decides to use an alternative therapy that no longer requires peripheral access All catheters will be stabilized using the same form of stabilization device for uniformity in securement procedure throughout the duration of the study
Daily assessments will occur per facility policy and procedure An assessment will include any level of pain andor tenderness presence of erythema edema induration leakage of fluid or purulent drainage from the puncture site catheter dysfunction eg resistance when flushing absence of a blood return Daily assessment will continue until the device is removed completion of therapy or discharge Once all the required data is collected all de-identified data will be entered as a data set into the post procedure CRF for managementanalysis The final paper CRF will be placed in a study folder and maintained for record keeping and data analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None