Policy change inatiave : the effectiveness of early position change post cardiac catheterization on patients outcomes

After signing the consent form for each eligible patient, the patients were assigned randomly to one of the study groups. Each patient was assigned to a random sequential number which was at an envelope in which it contains the random number, consent form, the pain assessment tool (NPS), sheet of demographical data and sheet of physiological data ( heart rate, oxygen sat , respiratory rate).
The sample of 120 patients was randomly and equally divided to two groups (I.e.60 patients). Each patient in CCU was connected to an electronic monitor to check physiological data (HR, RR, O2 SAT) every 15 minutes for the first hour, then every 30 minutes for the second hour then hourly for the next 6 hours, and at 8 am the morning after the procedure, the same for the IMCU patients but they will not be attached to an electronic monitor.
In the control group, patients did not receive any intervention, just the routine nursing care.

2018-03-01

2018-06-01

independent variable: early position change dependent variables: low back pain, urenary retention comfortable bleeding and hematoma as a risk facto.

A pragmatic randomized control trial (RCT) was used to test efficacy of positioning vs. remaining in supine position for the reduction of symptoms post cardiac catheterization. Pragmatic trials designed to evaluate the effectiveness of interventions in real-life routine practice conditions. Clinical trials, especially randomized controlled trials (RCTs), are designed as experiments with high internal validity to determine cause-effect relationships.
These experiments employ comprehensive designs to control for most, if not all, sources of bias (systematic errors) by means of randomization, blinding, and allocation concealment. Usually, extended inclusion and exclusion criteria are used to identify a clearly defined population group of participants who would benefit from the intervention under investigation. Pragmatic trials aim to evaluate interventions and compare their effectiveness at real life.
Random assignment of participants to experimental groups is considered one of the strengths of the experimental design for testing a cause-and-effect relationship (Jadad, 1998). ). In this study, random assignment of intervention is carried out after participants have been assessed for eligibility and recruited and after doing cardiac catheterization. In This clinical study, participants were assigned to either the intervention or control group, giving each subject equal probability of being assigned to either group.

Randomization procedure was computerized by randomization program prior to the study by the collaborating statistician. The process produced a random sequence of intervention allocations linked with study identification numbers, ranking from one to 120. The randomization procedure ensured that each study identification number had an equal probability of being allocated to treatment or control group.
In this study, each patient was randomly assigned to one of two groups:
1. The first group included patients who had cardiac catheterization procedure and whom assigned randomly to control group which had routine nursing care.
2. The second group was all patients who have been randomly assigned to change their position early after one hour of sheath removal.

The target population are all patients diagnosed with coronary artery diseases. Accessible population are coronary artery disease patients who undergo scheduled and emergency cardiac catheterization, whether it will be diagnostic or treatment procedure.

Yes

120 patients went cardiac catheterization.

120 observations.

60 patients control, 60 patients interventional.

The target population size for the study was about N=1000 patients. The sample size required from the target population was120. A similar number was noticed from reviewing previous similar studies show that a sample size of 120 patients allocated equally to two groups was sufficient to detect clinically significant improvement of the early position change post cardiac catheterization on patient’s outcomes. In the current study, the sample size was calculated for the outcomes according to the result of similar studies, for a two-sided hypothesis test with a type 1 error rate of 5% (95% CI) and a type two error rate of 10% (90% power), and a standard deviation of 1.7 were assigned to two groups of 60 persons in each group.