Predictors and Outcomes of Time to Hemostasis After Cardiac Catheterization
Study Details
Study Description
Brief Summary
This study aims to:
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Assess the incidence of hemostasis failure after manual compression of trans-femoral arterial sheath post percutaneous coronary intervention.
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Assess the predictors of time to hemostasis achieved by manual compression for trans-femoral arterial sheath post percutaneous coronary intervention.
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Assess the association between time to hemostasis and the incidence of vascular access complications after manual compression for trans-femoral arterial sheath removal post percutaneous coronary intervention.
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Assess the association between failed hemostasis and the incidence of vascular access complications after manual compression for trans-femoral arterial sheath removal post percutaneous coronary intervention.
| Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
Nurses and medical professionals have a vital role in detecting, preventing, and managing complications at the earliest possible stage. They should assess patients for high risk of complications, and plan management strategies to decrease those complications. In many acute and critical care settings, removing femoral sheaths and handling related complications after percutaneous coronary intervention. are primarily the responsibilities of nurses. Therefore, after catheterization procedures, assessing the predictors of required time to achieve optimal hemostasis at the time of trans-femoral arterial sheath removal is essential as one of the final modifiable measures to prevent access site complications. This study will be done in 6 Cardiac catheterization units representing governmental and private hospitals. A sample size of 266 patients will be recruited for the study. data will be analyzed by univariate and multivariate analysis.
Study Design
Outcome Measures
Primary Outcome Measures
- Time to hemostasis [12 hours after percutaneous coronary intervention]
The time frame (minutes) required for manual compression from the removal of sheath to achieve hemostasis
- Pre-procedure predictor factors associated with change of the mean time to hemostasis [before percutaneous coronary intervention]
Patient and procedure-related factors will be assessed by patient demographics and clinical data questionnaire. This questionnaire will gather data regarding patient demographics, comorbidities, risk factors, blood chemistry medications taken, and angiographic factors that can predict the mean time to safe hemostasis.
- Intra-procedure- predictor factors associated with a change in the mean time to hemostasis [during percutaneous coronary intervention]
Intra-procedure factors as measured by the percutaneous coronary intervention factors assessment checklist. This checklist will gather data regarding, puncture site, the number of punctures, guiding Catheter size, medications taken, procedure duration, amount of dye used, fluoroscopy time and the procedure done, and years of operator experience. These factors will be analyzed using multiple regression to identify intra-procedure predictor factors associated with a change in the mean hemostasis time.
- Trans-Femoral Arterial Sheath Removal Predictor factors associated with a change in the mean time to hemostasis [12 hours after percutaneous coronary intervention "during arterial sheath removal"]
Trans-Femoral Arterial Sheath Removal Variables checklist. This checklist gathers data regarding sheath removal time after the procedure, heart rate, and blood pressure before and after sheath removal, failed closure, ambulation time after sheath removal qualification, and years of experience of the health care provider who removes the sheath. These factors will be analyzed using multiple regression to identify trans-femoral arterial sheath removal factors associated with a change in the mean hemostasis time.
- Rate of the vascular Access Complications occurrence [12 hours after percutaneous coronary intervention "during arterial sheath removal"]
Complication rate as assessed by the number of events for oozing, ecchymosis, hematoma, bleeding, pseudoaneurysm, arteriovenous fistula, and femoral occlusion as assessed by the assigned nurse and treating physician
- Rate of the vascular Access Complications occurrence [6 hours after sheath removal]
Complication rate as assessed by the number of events for oozing, ecchymosis, hematoma, bleeding, pseudoaneurysm, arteriovenous fistula, and femoral occlusion as assessed by the assigned nurse and treating physician
- Rate of the vascular Access Complications occurrence [12 hours after sheath removal]
Complication rate as assessed by the number of events for oozing, ecchymosis, hematoma, bleeding, pseudoaneurysm, arteriovenous fistula, and femoral occlusion as assessed by the assigned nurse and treating physician
- Rate of the vascular Access Complications occurrence [immediately before patient discharge from the hospital]
The complication rate will be assessed by the number of events for oozing, ecchymosis, hematoma, bleeding, pseudoaneurysm, arteriovenous fistula, and femoral occlusion as assessed by the assigned nurse and treating physician.
Secondary Outcome Measures
- Groin pain [Immediately after femoral sheath removal]
Severity of the pain experienced by the patient as assessed by the pain Visual Analog Scale. the scale score range from 0-10. score of 0 indicate "no pain", 1-3 " mild pain", 4-6 "moderate pain", and 7-10 " severe pain"
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients who planned for elective or primary percutaneous coronary intervention with femoral access, and
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Agreed to participate in the study
Exclusion Criteria:
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Patients who had trans-femoral catheterization procedure within a 1-month duration
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patients with a known history of coagulation disorders,
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patients with sheath removed at the laboratory, and
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Patients who experience post - catheterization life-threatening events rather than vascular access complications
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Andalusia private hospital | Alexandria | Egypt | ||
| 2 | German Heart Center | Alexandria | Egypt | ||
| 3 | International Cardiac Center | Alexandria | Egypt | ||
| 4 | Mabaret Aalsafra hospital | Alexandria | Egypt | ||
| 5 | Shark El-Madina Hospital | Alexandria | Egypt | ||
| 6 | Smouha University Hospital | Alexandria | Egypt |
Sponsors and Collaborators
- Alexandria University
Investigators
- Principal Investigator: Maha G Asal, Phd, Alexandria University
- Principal Investigator: Eshrak S Hashem, Phd, Alexandria University
- Principal Investigator: Wafaa H Awad, Phd, Alexandria University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1552022