This study aims to: 1. Assess the incidence of hemostasis failure after manual compression of trans-femoral arterial sheath post percutaneous coronary intervention. 2. Assess the predictors of time to hemostasis achieved by manual compression for trans-femoral arterial sheath post percutaneous coronary intervention. 3. 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. 4. 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.
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 Type
OBSERVATIONAL
Enrollment
300
Andalusia Private Hospital
Alexandria, Egypt
German Heart Center
Alexandria, Egypt
Mabaret Aalsafra hospital
Alexandria, Egypt
Shark El-Madina Hospital
Alexandria, Egypt
Smouha University hospital
Alexandria, Egypt
Time to hemostasis
The time frame (minutes) required for manual compression from the removal of sheath to achieve hemostasis
Time frame: 12 hours after percutaneous coronary intervention
Pre-procedure predictor factors associated with change of the mean time to hemostasis
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.
Time frame: before percutaneous coronary intervention
Intra-procedure- predictor factors associated with a change in the mean time to hemostasis
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.
Time frame: during percutaneous coronary intervention
Trans-Femoral Arterial Sheath Removal Predictor factors associated with a change in the mean time to hemostasis
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.
Time frame: 12 hours after percutaneous coronary intervention "during arterial sheath removal"
Rate of the vascular Access Complications occurrence
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
Time frame: 12 hours after percutaneous coronary intervention "during arterial sheath removal"
Rate of the vascular Access Complications occurrence
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
Time frame: 6 hours after sheath removal
Rate of the vascular Access Complications occurrence
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
Time frame: 12 hours after sheath removal
Rate of the vascular Access Complications occurrence
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.
Time frame: immediately before patient discharge from the hospital
Groin pain
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"
Time frame: Immediately after femoral sheath removal
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