This randomized controlled trial was conducted from July to November 2018 in Shafa Hospital in Kerman, Iran. Seventhly eligible patients, after CABG surgery in the open-heart ICU in Shafa Hospital affiliated to Kerman University of Medical Sciences were enrolled in the study.
The inclusion criteria were: age within 18 - 60 years, undergoing non-emergency CABG surgery, having cognitive, speaking and hearing ability, not being addicted, no history of open heart surgery, no sever pulmonary disease, no renal dysfunction, no mechanical ventilation longer than 24 h after surgery, and no known psychological illness.
On the other hand, the exclusion criteria included: unwillingness to stay in the study, initiation of early complications after surgery (such as: cardiac shock, sever hypotension, bleeding, cardiac tamponade, kidney dysfunction), dangerous dysrhythmia (such as: atrial fibrillation and ventricular tachycardia), loss of consciousness, cerebral difficulties, renal and pulmonary complications, congestive heart failure, deep vein thrombosis, bleeding, myocardial infarction, being connected to the ventilator for more than 48 hours.
The sampling was performed based on the inclusion criteria. For all subjects in two groups, after complete consciousness, stability of the vital signs within 6 and 7 h after the surgery, and removal of the tracheal tubing in the evening shift, initially the arterial blood gas analysis as the main outcome was performed. Then, the pain severity, heart rate, and respiratory rate were measured as the secondary outcomes. Note that all patients in this department have an arterial line and before removal of the tracheal tubing, the arterial blood gas analysis is performed every 2 - 4 hours, but after removal of the tracheal tubing, this test is performed as needed.
In the ACBT group, the patient was placed in a fowler position. The ACBT was performed in three stages. The first stage was the breathing control. In this stage, breathing was carried out slowly through the nose. If breathing through the nose was not possible, it was done through the mouth. This should be performed with the "lips of the bud". During this step, the patient is encouraged to maintain calm by closing their eyes and away from any tension. Then he/she places one hand on his/her abdomen and exhales as if the shoulders move downwards and feel burning in the abdominal area. The second stage is the practice of extending the chest wall to provide airflow in small airways. At this stage, the air flows deeply, slowly and continuously through the nose into the lungs, so that the chest wall is expanded. The air is held for 2 - 3 seconds, and then it deflates out slowly and through the mouth. This step was repeated 3 times. The final was the huff stage and the integral part of this technique. In this stage, coughing was done through open mouth and throat. This will move the discharge from small airways to the larger airways and eventually discharges it. For this purpose, at first, the patient performed an intermediate respiration. Next, with opened mouth and with the help of respiratory muscles, he/she took a deep tail and then coughed. The ACBT intervention was performed on the two consecutive days after operation, each day one session, each session 3 courses and each course for 10 minutes with 15 minutes of rest between them.
For the routine physiotherapy group, chest wall vibrations and manual percussions were done. For this purpose, a vibrating device with a constant frequency of 50 Hz per second was used for 1.5 minutes, which was performed by placing the device on the patient's anterior and posterior chest wall. Then, the hand percussion was carried out on the anterior and posterior chest wall of the patient, using a hand palm which came in the form of a cup and from the wrist area, at a height of 10 cm. The vibration and precaution were done on a bed sheet. Manual percussion was performed 25 times in 10 seconds for 2 minutes. Then, the patient was encouraged to do effective coughs.
All patients received the basic post-operative care such as early mobilization, changes in positioning, and active exercises of the upper limbs.
Immediately after the completion of the routine physiotherapy and the ACBT in both groups, again the arterial blood gas levels were measured. Also, for both groups, the pain severity, heart rate, and respiratory rate were measured post intervention.
The sample size was considered to be approximately 70 (35 for each group) according to the following formula with a standard deviation of 11 at the significance level of 0.05 and power of 90%, along with the effect size of 9 in terms of minimum significant changes in average partial pressure oxygen (
23).
Overall, 70 patients were assigned into ACBT and routine chest physiotherapy groups equally based on sex classes via minimization method (
24). The samples were randomly placed in the classes, where eventually the total number in each class would be equal. Sampling continued until reaching the sample size.
Data collection was done by face-to-face interviews. The data collection tool included a demographic questionnaire (age, sex, smoking history), and the 10-degree visual analog scale (VAS) for pain intensity evaluation. This tool was standard and its validity and reliability were confirmed (
24). For evaluation of respiratory parameters, the arterial blood gas was analyzed which contained: partial pressure oxygen (PaO
2), arterial oxygen saturation (SaO
2), partial pressure carbon dioxide (PaCo
2), arterial PH, and bicarbonate level (HCO
3). The pulse and respiration rate were also recorded. Arterial blood gas analysis was conducted by the GEM Premier 3000, USA (
25), which was calibrated at the patient's temperature during sampling using 300-bit cartridge made by GEM Premier USA.
The study was approved by the Research Council and Ethics Committee of Rafsanjan University of Medical Sciences (with ethical code number: IR.RUMS.REC.1397.010). This trial was also registered at the Iranian Clinical Trial Registry (with the IRCT identification code: IRCT20180304038935N1). All participants were informed of the study objectives and explained that their company is voluntary and may leave the study whenever they wished. Prior to entering the study, all participants signed a written informed consent form and were assured that their presence or absence in the study did not influence their routine care in the hospital.
Data analysis was performed by SPSS software V.22 using Kolmogorov-Smirnov test, chi-square test, paired samples t test, independent two samples t-test, Wilcoxon signed ranks test, and the Mann-Whitney U test, at a significance level of 0.05.