Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06216522
Status:
COMPLETED
Last Update Posted:
2024-02-21
First Post:
2024-01-11
Brief Title:
The Effectiveness of Topical Sesame Oil in Preventing Phlebitis at IV Cannula Sites in Adults
Sponsor:
National Heart Centre Singapore
Organization:
National Heart Centre Singapore
Study Overview
Official Title:
A Randomised-controlled Trial on the Effectiveness of Topical Sesame Oil in Preventing Phlebitis at Intravenous Cannula Sites in Adult Patients
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this randomised controlled trial is to determine the effectiveness of topical sesame oil in preventing phlebitis at peripheral intravenous IV cannula sites in adult patients within a cardiovascular and cardiothoracic department of a tertiary hospital
The main question it aims to answer is
Is topical sesame oil effective in preventing phlebitis at peripheral IV cannula sites in adult patients within a cardiovascular and cardiothoracic department of a tertiary hospital
Participants will be randomly allocated to the experimental or control group with the use of a randomisation software MS excel They will each have five drops025mls of 100 sesame oil experimental or liquid paraffin oil control applied to the IV cannula site at 12 hourly intervals for a total of 72 hours from 3cm above the insertion point to 10cm along the vein with a width of 2cm on either side
Researchers will compare the phlebitis incidence and severity of each group to see if topical sesame oil is more effective than liquid paraffin oil in preventing phlebitis at IV cannula sites in adult patients within a cardiovascular and cardiothoracic department of a tertiary hospital
The main question it aims to answer is
Is topical sesame oil effective in preventing phlebitis at peripheral IV cannula sites in adult patients within a cardiovascular and cardiothoracic department of a tertiary hospital
Participants will be randomly allocated to the experimental or control group with the use of a randomisation software MS excel They will each have five drops025mls of 100 sesame oil experimental or liquid paraffin oil control applied to the IV cannula site at 12 hourly intervals for a total of 72 hours from 3cm above the insertion point to 10cm along the vein with a width of 2cm on either side
Researchers will compare the phlebitis incidence and severity of each group to see if topical sesame oil is more effective than liquid paraffin oil in preventing phlebitis at IV cannula sites in adult patients within a cardiovascular and cardiothoracic department of a tertiary hospital
Detailed Description:
The goal of this randomised controlled trial is to determine the effectiveness of topical sesame oil in preventing phlebitis at peripheral intravenous IV cannula sites in adult patients within a cardiovascular and cardiothoracic department of a tertiary hospital
All newly admitted patients with an existing IV cannula will be approached after being admitted into an inpatient ward This will take place within 12 hours of the IV cannula insertion They will not be approached if in distress drowsy or immediately prior to a surgical procedure The IV cannula will be tested for patency and assessed for redness swelling pain a palpable venous cord or pyrexia If any of these symptoms are present or if the IV cannula is not patent the recruitment will be terminated
Participants will be randomly allocated to the experimental or control group with the use of a randomisation software MS excel They will each have five drops025mls of 100 sesame oil experimental or liquid paraffin oil control applied to the IV cannula site at 12 hourly intervals for a total of 72 hours from 3cm above the insertion point to 10cm along the vein with a width of 2cm on either side
Demographic and clinical data will be recorded into a table The patient will be instructed not to wash or wipe the topical agent off The time and date of the start of treatment applied and subsequent treatments at 12 hour intervals will be documented At the start of the study and at each 12 hour interval the investigator will observe for signs of phlebitis using the modified Visual Infusion Phlebitis VIP scoring tool 1 before application of the next treatment The study investigators will be the only ones applying the treatmentcontrol and completing the data collection form every 12 hours
Application of the treatment or control will be made every 12 hours for up to 72 hours where the IV cannula will then be removed according to hospital guidelines The IV cannula site will be observed every 12 hours for up to 24 hours post IV cannula removal for phlebitis or complications
Patients will be withdrawn from the study the moment they show signs of adverse reactions from the topical treatment or control
Participants will be involved in the study for a maximum of 96 hours If the IV cannula is removed accidentally or not due to phlebitis before the 72-hour period is up re-insertion of a new cannula and re-application of oils will not be done on a new site
The application of either sesame oil or liquid paraffin oil is not part of the routine procedures or standard of care in the ward and will only be applied for the purpose of this research Both the sesame oil and liquid paraffin oil are marketed products and will be used as per label
All hardcopy research data will be stored in in a locked cupboard with lock and key access within the National Heart Centre Singapore All soft copies will be stored in a password protected Laptop belonging to the principal investigator Only the principal investigator will have access to the research data All other members of the research team will access the data through the principal investigator The physical research data will be kept under lock and key for 7 years after the completion of the research study or date of publication of the research using the research data whichever is later After which all data will be destroyed Hardcopies will be shredded and soft copies will be deleted
Subjects may withdraw voluntarily from participation in the study at any time Subjects may also withdraw voluntarily from receiving the study intervention for any reason Upon withdrawal IV cannula sites will continue to be observed for 24 hours at 12-hour intervals for potential reactions to the oils or signs of phlebitis If there are any adverse reactions to the oils or signs of phlebitis during the 24-hour observation period the patient will be referred to the attending physician and medical treatment will be rendered The patient will continue to receive follow-up and medical treatment until symptoms have resolved
The study may be discontinued at any time if safety issues arise If the risks to participants unexpectedly outweigh the benefits due to unexpected severe adverse events due to the application of the treatment or control oils the study may then be suspended until the risk-benefit ratio is re-evaluated
All newly admitted patients with an existing IV cannula will be approached after being admitted into an inpatient ward This will take place within 12 hours of the IV cannula insertion They will not be approached if in distress drowsy or immediately prior to a surgical procedure The IV cannula will be tested for patency and assessed for redness swelling pain a palpable venous cord or pyrexia If any of these symptoms are present or if the IV cannula is not patent the recruitment will be terminated
Participants will be randomly allocated to the experimental or control group with the use of a randomisation software MS excel They will each have five drops025mls of 100 sesame oil experimental or liquid paraffin oil control applied to the IV cannula site at 12 hourly intervals for a total of 72 hours from 3cm above the insertion point to 10cm along the vein with a width of 2cm on either side
Demographic and clinical data will be recorded into a table The patient will be instructed not to wash or wipe the topical agent off The time and date of the start of treatment applied and subsequent treatments at 12 hour intervals will be documented At the start of the study and at each 12 hour interval the investigator will observe for signs of phlebitis using the modified Visual Infusion Phlebitis VIP scoring tool 1 before application of the next treatment The study investigators will be the only ones applying the treatmentcontrol and completing the data collection form every 12 hours
Application of the treatment or control will be made every 12 hours for up to 72 hours where the IV cannula will then be removed according to hospital guidelines The IV cannula site will be observed every 12 hours for up to 24 hours post IV cannula removal for phlebitis or complications
Patients will be withdrawn from the study the moment they show signs of adverse reactions from the topical treatment or control
Participants will be involved in the study for a maximum of 96 hours If the IV cannula is removed accidentally or not due to phlebitis before the 72-hour period is up re-insertion of a new cannula and re-application of oils will not be done on a new site
The application of either sesame oil or liquid paraffin oil is not part of the routine procedures or standard of care in the ward and will only be applied for the purpose of this research Both the sesame oil and liquid paraffin oil are marketed products and will be used as per label
All hardcopy research data will be stored in in a locked cupboard with lock and key access within the National Heart Centre Singapore All soft copies will be stored in a password protected Laptop belonging to the principal investigator Only the principal investigator will have access to the research data All other members of the research team will access the data through the principal investigator The physical research data will be kept under lock and key for 7 years after the completion of the research study or date of publication of the research using the research data whichever is later After which all data will be destroyed Hardcopies will be shredded and soft copies will be deleted
Subjects may withdraw voluntarily from participation in the study at any time Subjects may also withdraw voluntarily from receiving the study intervention for any reason Upon withdrawal IV cannula sites will continue to be observed for 24 hours at 12-hour intervals for potential reactions to the oils or signs of phlebitis If there are any adverse reactions to the oils or signs of phlebitis during the 24-hour observation period the patient will be referred to the attending physician and medical treatment will be rendered The patient will continue to receive follow-up and medical treatment until symptoms have resolved
The study may be discontinued at any time if safety issues arise If the risks to participants unexpectedly outweigh the benefits due to unexpected severe adverse events due to the application of the treatment or control oils the study may then be suspended until the risk-benefit ratio is re-evaluated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None