Evaluation of Blood Sampling From a Pre-existed Peripheral Intravenous Catheter Line
Primary Purpose
Emergencies
Status
Recruiting
Phase
Phase 4
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Normal saline
Sponsored by
About this trial
This is an interventional diagnostic trial for Emergencies
Eligibility Criteria
Inclusion Criteria:
- It will include healthy adult volunteers.
Exclusion Criteria:
- Pediatric patients and critically ill patients will be excluded from the study
Sites / Locations
- King Fahd University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Normal saline
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05543772
First Posted
June 5, 2022
Last Updated
October 11, 2023
Sponsor
Imam Abdulrahman Bin Faisal University
1. Study Identification
Unique Protocol Identification Number
NCT05543772
Brief Title
Evaluation of Blood Sampling From a Pre-existed Peripheral Intravenous Catheter Line
Official Title
Evaluation of Blood Sampling From a Pre-existed Peripheral Intravenous Catheter Line (Indwelling Line): a Technique to Keep Optimal Specimen After Fluid Flush
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Imam Abdulrahman Bin Faisal University
4. Oversight
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
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergencies
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Normal saline
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
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
Primary Outcome Measure Information:
Title
Comparison of pCO2, pO2 (mmHg) Before and After IV Fluid Infusion in Healthy Adults
Description
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.
Time Frame
1 year
Title
Comparison of PH Before and After IV Fluid Infusion in Healthy Adults
Description
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.
Time Frame
1 year
Title
Comparison of ctHb (g/dL) Before and After IV Fluid Infusion in Healthy Adults
Description
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.
Time Frame
1 year
Title
Comparison of SO2, FO2Hb, FCOHb, FMetHb (%) Before and After IV Fluid Infusion in Healthy Adults
Description
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.
Time Frame
1 year
Title
Comparison of cBase(Ecf)c, cHCO,-(P.st)c, cNa, cK, cCl, cCa (mmol/L) Before and After IV Fluid Infusion in Healthy Adults
Description
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.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
It will include healthy adult volunteers.
Exclusion Criteria:
Pediatric patients and critically ill patients will be excluded from the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dunya N Alfaraj, MD
Phone
00966541167170
Email
dnfaraj@iau.edu.sa
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dunya N Alfaraj, MD
Organizational Affiliation
Imam Abdulrahman Bin Faisal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Fahd University Hospital
City
Khobar
State/Province
East
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dunya N Alfaraj, MD
Phone
00966541167170
Email
doniaalfaraj@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Not decided yet
Learn more about this trial
Evaluation of Blood Sampling From a Pre-existed Peripheral Intravenous Catheter Line
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