Study design
The study was conducted as prospective, cohort, randomized controlled trial (RCT). This design was adopted due the strength of the hierarchy of scientific evidence, namely, reduced bias and more accurate results.
Study Setting and Population
The study was conducted at AN Najah National University Hospital. Data was collected from CCU and Intermediate CCU wards. An-Najah National University Hospital has 200 beds, 5 beds for CCU and 16 beds for Intermediate CCU. It is a non-profit hospital, located in the Northern West Bank, Palestine.
Participants are adult patients scheduled for coronary artery bypass surgery, aged 18 or older, and patients who were well motivated and compliant.
Sample and sampling
To investigate the optimal sample magnitude for the trial that safeguards an adequate effect to identify statistical significance, the effect of the trial was estimated at 80 percent power, with alpha levels at (p ≤0.05). Sample magnitude was computed as 37 patients for each group by using A formula (i.e., Pocock's sample size formula) that can be directly applied for comparison of proportions P1 and P2 in two equally sized groups. To raise the potential of the current trial, we recruited 40 patients in every group as has also been done in early studies.
Inclusion and exclusion criteria
Inclusion :18 years or older, scheduled to have coronary artery bypass grafting (CABG) and patients who were well motivated and compliant.
Exclusion: Patients who are expected not to be able to conduct or comply with IS, such as patients with cognitive or neurological deficits, patients with coexisting acute or chronic respiratory disorders, patients unable to understand or show the proper use of the incentive spirometer, patients who cannot be instructed or supervised to assure appropriate use of the device, patients in whom cooperation is absent or patients unable to understand or demonstrate proper use of the device, patients who are confused or delirious, patients undergoing any other surgery along with CABG, having prolonged mechanical ventilation (more than 24 hours) or re-intubation, patients undergoing emergency CABG surgery, chronic obstructive pulmonary disease (COPD), asthma, restrictive lung disease, preoperative major chest infection e.g. pulmonary tuberculosis, chest deformities such as pectus carinatum, pectus excavatum, thoracolumbar scoliosis, diaphragmatic hernias diagnosed on history.
Randomization and Blindness
The participants who met the inclusion criteria were randomized into two groups according to a randomization list formatted by www.randomization.com.
Group 1: Incentive spirometry was utilized by the patient with 10 breaths, 6 times per day for a period of 10 minutes in every session with a breathing technique for 2 days preoperatively. The patients were taught how to use IS by a nurse who would not be involved in the patient’s postoperative care. (Experimental group) (IS).
Group 2: No IS preoperatively, only IS postoperatively (Control Group)
The patients, health care providers included in the patient care are unaware of the treatment group allocation.
Measured Outcomes:
The primary outcome was defined as respiratory complications that occur within 48–72 h following surgery, which include: atelectasis, pneumonia, pleural effusion, and Pneumothorax. Which measured by x-ray and clinical sign and symptom[33] . Secondary outcomes included hospital length of stay that calculated by subtracting day of admission from day of discharge[34]. Mechanical ventilation duration in hours, oxygenation status by measuring Pao2 and SaO2 by ABG’s, and control pain by using numerical pain scale.
Measurement and data collection procedure
The participants who met the inclusion criteria and randomized to the intervention group were given a flow-based incentive spirometer and asked to use spirometry with deep-breathing exercise 2 days preoperatively until surgery. They were asked to hold the spirometer in the upright position, place their lips tightly across the spirometer mouthpiece, and then they were asked to slowly inhale air into the lungs to raise the ball to the target position. After that, the mouthpiece was removed and patients were asked to hold their breath for at least 5 seconds followed by normal expiration. Incentive spirometry was done with 10 breaths, 6 times per day for a period of 10 minutes every session before surgery according to literature and An-Najah National University hospital.
Observations and hemodynamic parameters were measured preoperatively and postoperatively. For both groups, study observations were recorded every 6 hours. Both groups postoperative received the same intervention: the exercises began on the morning after surgery with incentive spirometry, deep-breathing exercise and physiotherapy after Extubation, and early mobilization, in accordance with An-Najah University Hospital protocol. A data sheet containing the following information was filled out for each patient: name, age, height, weight, body mass index, respiratory status, medical history, presence of respiratory complications, duration of MV, and numerical pain scale and hospital length of stay.
The data collection sheet was prepared after going throughout the linked literature and with the supervision of experts in the field. Content validity is defined as “the degree to which objects in an instrument reflect the content universe to which the instrument will be generalized [35]. Content validity was applied while the data sheet was developed to ensure that it included all items that was essential [36, 37]. The assessment method for determining the validity of the data sheet included literature reviews and then follow-ups with evaluation by expert judges or panels (two intensivists, one anaesthesiologist, and three nurses in critical care), all experts’ suggestions were taken into account.
Thoracic x-rays were taken during the preoperative period, as well as immediately following surgery in the intensive cardiac care unit (ICCU), on the ward, once the drains had been removed (48 hours after surgery), and on discharge from hospital. X-ray examinations were performed at the same frequency for all patients in both groups.
Anaesthesia protocol
(AN-Najah National University Hospital protocol)
All patients in both groups received the same anaesthesia technique and ventilation in the operation room.
A standard induction for cardiac anaesthesia started with inhalation of sevoflurane 0–8% in 100% oxygen and fresh gas flow of 3 L/min for 5 min with a facial mask. After that, patients were given IV anaesthesia Propofol 2 mg/kg IV and tracheal intubation was facilitated with rucoronium 1.5 to 2 mg/kg with fentanyl 2-20mcg/kg/dose initially.
Maintenance of anaesthesia
Anaesthesia was maintained with sevoflurane 0–3% in 50% oxygen and 50% air. Neuromuscular blockade was maintained with increments of atracurium with this equation: 0.3(dose)*kg/4(concentration/ml)= ml/hr, fentanyle was used to provide intraoperative analgesia with this equation: 2(dose)*kg/20(concentration/ml) = ml/hr as 1-2mcg/kg/hr maintenance.
For special cases like decreased ejection fraction and left main coronary disease, etomidate 0.3–0.6 mg/kg was used.
Ethical considerations
The institutional Review Board (IRB) of An-Najah National University approved the study. Consent forms were obtained from the patients prior to participation and the study was registered in Thai Clinical Trials Registry (no. TCTR20201020005). All patients were given both verbal and written information about the aim and objectives of the study before considering participation in the study. The study followed the World Health Organization Declaration on the Ethical Principles of Helsinki for Medical Research on Humans[38].
Analyses
The data were analysed with SPSS version 22 for Windows (IBM Corp., Armonk, NY, USA). Data normality was tested using Kolmogorov–Smirnov test. The data were not normally distributed. Thus, nonparametric statistics tests were used. The Scale data are expressed as the median (quartile 1 [Q1]–quartile 3 [Q3]). The groups were compared with the Mann-Whitney U Test. Categorical variables (YES/NO questions) were statistically analysed with Chi-square tests have been used. A P value ≤ 0.05 was considered to indicate a statistically significant difference.