Evaluation of Blood Sampling From a Pre-existed Peripheral Intravenous Catheter Line

October 11, 2023 updated by: Dunya N Alfaraj, MD, Imam Abdulrahman Bin Faisal University

Evaluation of Blood Sampling From a Pre-existed Peripheral Intravenous Catheter Line (Indwelling Line): a Technique to Keep Optimal Specimen After Fluid Flush

Background: Peripheral Intravenous catheter (PIVC) is a frequently used device for intravascular access. It is usually indicated to administer intravenous fluid and medications. However, the investigators could possibly utilize this line for blood sampling even after using it as a fluid port.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Aims: To investigate the quality of previously flushed PIVC sample and the effectiveness of the withdrawal technique.

Methodology: Study will be held in King Fahad University Hospital during a year after obtaining the IRB approval. Selection of study participants will be depending on their health status and the investigators will exclude pediatric participants. Two blood samples will be collected from participants. First one is after the insertion of the intravenous peripheral line. The second is after fluid infusion through the same line. Samples will be sent to the laboratory then. Results will be collected and analyzed.

The importance of the research: If this type of sampling can be standardized , this means there will be less insertions to the patients, less adverse effects in relation to the number of insertions, fast and preexisted intravascular access for sampling so the time can be saved in critical conditions.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Saudi Arabia
    • East
      • Khobar, East, Saudi Arabia
        • Recruiting
        • King Fahd University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • It will include healthy adult volunteers.

Exclusion Criteria:

  • Pediatric patients and critically ill patients will be excluded from the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Normal saline
Study will be held in King Fahad University Hospital during a year after obtaining the IRB approval. Selection of study participants will be depending on their health status and the investigators will exclude pediatric participants. Two blood samples will be collected from participants. First one is after the insertion of the intravenous peripheral line. The second is after fluid infusion through the same line. Samples will be sent to the laboratory then. Results will be collected and analyzed.
Drug: Normal saline
participant will be given 500 ml normal saline through intravenous access. blood sample will be extracted before and after giving normal saline using same intravenous catheter

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Comparison of pCO2, pO2 (mmHg) Before and After IV Fluid Infusion in Healthy Adults
Time Frame: 1 year
Blood samples will be analyzed using a venous blood gas (VBG) machine to assess pCO2, pO2 (mmHg). We will measure these values both before and after IVF infusion. The comparison of results aims to detect any statistically significant changes. This approach prioritizes patient comfort by utilizing the same catheter and requiring only a minimal blood discard.
1 year
Comparison of PH Before and After IV Fluid Infusion in Healthy Adults
Time Frame: 1 year
Blood samples will be analyzed using a venous blood gas (VBG) machine to assess PH. We will measure these values both before and after IVF infusion. The comparison of results aims to detect any statistically significant changes. This approach prioritizes patient comfort by utilizing the same catheter and requiring only a minimal blood discard.
1 year
Comparison of ctHb (g/dL) Before and After IV Fluid Infusion in Healthy Adults
Time Frame: 1 year
Blood samples will be analyzed using a venous blood gas (VBG) machine to assess ctHb (g/dL) . We will measure these values both before and after IVF infusion. The comparison of results aims to detect any statistically significant changes. This approach prioritizes patient comfort by utilizing the same catheter and requiring only a minimal blood discard.
1 year
Comparison of SO2, FO2Hb, FCOHb, FMetHb (%) Before and After IV Fluid Infusion in Healthy Adults
Time Frame: 1 year
Blood samples will be analyzed using a venous blood gas (VBG) machine to assess SO2, FO2Hb, FCOHb, FMetHb (%). We will measure these values both before and after IVF infusion. The comparison of results aims to detect any statistically significant changes. This approach prioritizes patient comfort by utilizing the same catheter and requiring only a minimal blood discard.
1 year
Comparison of cBase(Ecf)c, cHCO,-(P.st)c, cNa, cK, cCl, cCa (mmol/L) Before and After IV Fluid Infusion in Healthy Adults
Time Frame: 1 year
Blood samples will be analyzed using a venous blood gas (VBG) machine to assess cBase(Ecf)c, cHCO,-(P.st)c, cNa, cK, cCl, cCa (mmol/L). We will measure these values both before and after IVF infusion. The comparison of results aims to detect any statistically significant changes. This approach prioritizes patient comfort by utilizing the same catheter and requiring only a minimal blood discard.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Imam Abdulrahman Bin Faisal University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dunya N Alfaraj, MD, Imam Abdulrahman Bin Faisal University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 16, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IABFUniversity

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Not decided yet

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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