Study design and participants
The study was conducted as a prospective observational investigation involving patients who underwent open-heart surgery and were admitted to the cardiovascular surgery intensive care unit between September and December 2022.
A study was referenced to determine sample size10. The sample size was calculated by power analysis method (G*Power 3.1) using difference between two independent means. Accordingly, with 95% power analysis and 0.05% margin of error, a total of 34 patients, 17 with a history of Covid-19 and 17 without. Our study was to be completed with 70 individuals, with 35 having a Covid-19 history and 35 without. The inclusion criteria for patients were being over 18 years old, being able to communicate, having a planned surgery, and accepting to participate in the study voluntarily. Exclusion criteria were refusing to participate in the study, having received an intra-aortic balloon and extracorporeal membrane oxygenation therapy, under-going an urgent surgery, and having post-operative unconsciousness.
Data collection tools
The Patient Information Form was used to collect demographic characteristics (age, gender, educational status, etc.), clinical status (comorbidity, Covid-19 history, vaccination, previous surgery, etc.), and post-operative data (on-pump time, ventilation time, intensive care unit stay, mobilization time, etc.).
Data collection
The patients were visited by the researchers at the clinics where they were hospitalized one day before the operation. The aim of the study was explained, and their Covid-19 background was assessed. The first 35 patients with and without a Covid-19 history who were scheduled to have surgery were included in the research. As of the start of the study, if a patient could not be recruited from either group, the next patient from both groups was excluded and the process was repeated with the subsequent patients. For example, if the tenth patient with a Covid-19 history was not included in the study, the tenth patient without a Covid-19 history was also excluded, and the study proceeded with the eleventh patients. When the first 35 patients with a Covid-19 history and the first 35 patients without a Covid-19 history agreed to participate in the study, they were monitored in the cardiovascular surgery intensive care unit. The researchers recorded the responses to the questions.
Ethics
Ethics committee approval was obtained from Trabzon Kanuni Training and Research Hospital (Decision no: 12/09/2022-2022/49). Institutional permission was obtained from hospital. Written informed consent was received from the patients who agreed to participate in the study. Patients were informed that they could leave the study at any time.
Statistical analysis
The Kolmogorov-Smirnov test was used to examine the suitability of the data for normal distribution. Percentages, mean, and standard deviation were used in the evaluation of descriptive data. The chi-square test was used to compare the Covid and non-Covid groups with categorical independent variables (Covid vaccination status, previous surgery, smoking, alcohol, etc.), and Mann Whitney U and correlation test were used to compare continuous variables (on-pump time during operation, ventilation time, spontaneous ventilation, etc.) for those not normally distributed.