NCT05543772

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2023

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 16, 2022

Completed
12 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

October 16, 2023

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

June 5, 2022

Last Update Submit

October 11, 2023

Conditions

Outcome Measures

Primary Outcomes (5)

  • Comparison of pCO2, pO2 (mmHg) Before and After IV Fluid Infusion in Healthy Adults

    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

    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

    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

    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

    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

Study Arms (1)

Normal saline

EXPERIMENTAL

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

Interventions

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

Normal saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • It will include healthy adult volunteers.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Fahd University Hospital

Khobar, East, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Emergencies

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Dunya N Alfaraj, MD

    Imam Abdulrahman Bin Faisal University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dunya N Alfaraj, MD

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Emergency Consultant

Study Record Dates

First Submitted

June 5, 2022

First Posted

September 16, 2022

Study Start

September 1, 2023

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

October 16, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Not decided yet

Locations