effect of air bag (femosup) in reducing complication after angioplasty

The comparison of two methods of sandbag and air bag (femosup) in reduction of coronary artery angioplasty complications

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT201206306342N2

Enrollment

Registered

2012-10-08

Start date

2012-06-21

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerotic heart disease. Atherosclerotic heart disease

Interventions

Intervention 1: use of air bag (femosup) immediatly after removal of sheath. Intervention 2: use of sand bag immediatly after removal of sand bag.

use of air bag (femosup) immediatly after removal of sheath

use of sand bag immediatly after removal of sand bag

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: Having sufficient consciousness to work with staff; have Arterial sheath in the right leg; use sheath no 6; received heparin as anticoagulant; arterial sheath is removed 5-6 hours after injection of heparin bolus dose. Exclusion criteria: Opiate addiction; psychological disease; previous use of analgesics and sedatives or tranquilizers during angioplasty; Integrilin received during angioplasty; previous used of Varfarin; angioplasty due to myocardial infarction; hematoma forms before extraction of the sheath; existence of musculoskeletal disease and low back pain; blood and hepatic diseases; peripheral vascular disease; Clotting problems; existence of venous sheath; To access the femoral artery needle is made more than once; systolic blood pressure is above 180 mm Hg; diastolic BP is above 100 mm Hg; use of Hemcan glue after extraction of the sheath.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Low back pain. Timepoint: begining of intervention, 3 and 6 hours after intervention. Method of measurement: numeric rating scale of pain.;Fatigue. Timepoint: begining of intervention, 3 and 6 hours after intervention. Method of measurement: numeric rating scale offatigue.;Groin discomfort. Timepoint: begining of intervention, 3 and 6 hours after intervention. Method of measurement: numeric rating scale of groin discomfort.;Hematoma. Timepoint: hours of 1,2,3,4,5,6. Method of measurement: Christensen scale.;Sedative intake. Timepoint: 18 hours after angioplasty. Method of measurement: Patient records.;Opiate intake. Timepoint: 18 hours after angioplasty. Method of measurement: patient records.;Sleep status. Timepoint: Day after angioplasty. Method of measurement: questionnaire.	—

Measure

Time frame

Low back pain. Timepoint: begining of intervention, 3 and 6 hours after intervention. Method of measurement: numeric rating scale of pain.;Fatigue. Timepoint: begining of intervention, 3 and 6 hours after intervention. Method of measurement: numeric rating scale offatigue.;Groin discomfort. Timepoint: begining of intervention, 3 and 6 hours after intervention. Method of measurement: numeric rating scale of groin discomfort.;Hematoma. Timepoint: hours of 1,2,3,4,5,6. Method of measurement: Christensen scale.;Sedative intake. Timepoint: 18 hours after angioplasty. Method of measurement: Patient records.;Opiate intake. Timepoint: 18 hours after angioplasty. Method of measurement: patient records.;Sleep status. Timepoint: Day after angioplasty. Method of measurement: questionnaire.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli Asghar Ghods

Semnan University of Medical Sciences

aaghods@yahoo.com+98 23 1335 4170

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026