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IRCT2014122920472N1 IRCT 2015-02-11 Shahid Sadoughi University of Medical Sciences and Health Services Evaluation of the effect of local cold pack application on bleeding and hematoma after Angioplasty Evaluation of the effect of local cold pack application on vascular access site bleeding and hematoma after sheath removal in patients undergoing Angioplasty & Stenting 2015-01-05 anticipated 66 Complete https://irct.ir/trial/18152 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention. N/A Angioplasty and Senting. Intervention 1: For reduce the effect of the intervention on the results, the selected samples are Angioplasty and stenting by a specialist, then the patient is transferred to the CCU. ACT will be reviewed by the researcher and if less than 180 seconds, the sheath is removed and immediately hand pressure applied equally by the same researcher assistance to both groups at the exit sheath for 20 minutes. The next step will be placed in the intervention group ice bag for 30 minutes on the sheath exit and bleeding and hematoma measure and record during and immediately after hemostasis (before using ice packs), 0.5, 1, 2, 4 and 6 hours after the onset of use ice packs, also the morning after angioplasty and stenting. The patient gets out of bed 6 hours after sheath removal to help the researcher. The dressing can be done at the patient's groin. Over time, the use of ice packs, bleeding is observed in the site of sheath removal . Intervention 2: In the control group, sand bags can be placed on the sheet removal site for 4 hours and the patient out of bed after 6 hours. In the control group, bleeding and hematoma measure and record during and immediately after hemostasis (before using sand bag), 0.5, 1, 2, 4 and 6 hours after the onset of use sand bag , also the morning after angioplasty and stenting. The patient gets out of bed 6 hours after sheath removal to help the researcher. The dressing can be done at the patient's groin. Over time, the use of sand bags, bleeding is observed in the site of sheath removal .
public Samane sadat Javadi
Nursing and Midwifery school, Bu ali avenue, Safaee, Yazd
Yazd Iran (Islamic Republic of) +98 35 3824 1755 samanejavadi@ssu.ac.ir javadi.samane@yahoo.com javadi2samane@gmail.com Shahid Sadoughi University of Medical Sciences and Health Services scientific Farahnaz Farnia
Nursing and Midwifery school, Bu ali avenue, Safaee, Yazd
Yazd Iran (Islamic Republic of) +98 35 3824 1755 far.farnia@yahoo.com Shahid Sadoughi University of Medical Sciences and Health Services Iran (Islamic Republic of) Inclusion Criteria: non-emergency angioplasty or stenting by femoral artery approach with a sheath size of 6 or 7 French; age between 18-80 years; the absence of active bleeding disorders; INR< 2; Not receiving thrombolytic drugs and only one try for entrancing sheaths in femoral artery. Exclusion Criteria: integrilin administration during the procedure; systolic and diastolic blood pressure over 190 and 110 respectively; complications during catheterization; need for cardio-pulmonary resuscitation (CPR); chest pain with ECG changes; hemodynamic impairment during the study; no sense of arterial pulses lower than sheath access point; presence of hematoma at the beginning of study in puncture site; foreign patients who are unable to cooperate 18 years 80 years Both Z95.5 Presence of coronary artery prosthesis Status following coronary angioplasty NOS Prevention Prevention For reduce the effect of the intervention on the results, the selected samples are Angioplasty and stenting by a specialist, then the patient is transferred to the CCU. ACT will be reviewed by the researcher and if less than 180 seconds, the sheath is removed and immediately hand pressure applied equally by the same researcher assistance to both groups at the exit sheath for 20 minutes. The next step will be placed in the intervention group ice bag for 30 minutes on the sheath exit and bleeding and hematoma measure and record during and immediately after hemostasis (before using ice packs), 0.5, 1, 2, 4 and 6 hours after the onset of use ice packs, also the morning after angioplasty and stenting. The patient gets out of bed 6 hours after sheath removal to help the researcher. The dressing can be done at the patient's groin. Over time, the use of ice packs, bleeding is observed in the site of sheath removal . In the control group, sand bags can be placed on the sheet removal site for 4 hours and the patient out of bed after 6 hours. In the control group, bleeding and hematoma measure and record during and immediately after hemostasis (before using sand bag), 0.5, 1, 2, 4 and 6 hours after the onset of use sand bag , also the morning after angioplasty and stenting. The patient gets out of bed 6 hours after sheath removal to help the researcher. The dressing can be done at the patient's groin. Over time, the use of sand bags, bleeding is observed in the site of sheath removal . Hematoma. Timepoint: Immediately after Hemostasis (before using ice packs), 0.5, 1, 2, 4 and 6 hours after the onset of ice packs and in the morning after Angioplasty and Stenting. Method of measurement: Rule-based cm2. Bleeding. Timepoint: Immediately after Hemostasis (before using ice packs), 0.5, 1, 2, 4 and 6 hours after the onset of ice packs and in the morning after angioplasty and stenting. Method of measurement: Scale with a sensitivity of 0.01 grams. Blood Pressure. Timepoint: During the study. Method of measurement: Monitoring. Shahid Sadoughi University of Medical Sciences and Health Services Approved 2014-11-08 Shahid Sadoughi University of Medical Sciences and Health Services Yazd, Ba Honar square, Shahid Sadoughi University of Medical Sciences and Health Services Yazd Iran (Islamic Republic of)