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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05543772
Other study ID # IABFUniversity
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date September 1, 2023
Est. completion date September 1, 2024

Study information

Verified date October 2023
Source Imam Abdulrahman Bin Faisal University
Contact Dunya N Alfaraj, MD
Phone 00966541167170
Email dnfaraj@iau.edu.sa
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date September 1, 2024
Est. primary completion date September 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - It will include healthy adult volunteers. Exclusion Criteria: - Pediatric patients and critically ill patients will be excluded from the study

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Saudi Arabia King Fahd University Hospital Khobar East

Sponsors (1)

Lead Sponsor Collaborator
Imam Abdulrahman Bin Faisal University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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