Study design, setting, and definition
This clinical trial study was conducted with pretest-posttest design and not blinded with trial registration number IRCT20200813048398N1; 2020-08-22, in the ICUs of Imam and Golestan hospitals in Ahvaz city-Iran. The sample size calculated to be 21 people in each group. The study samples (N=42) were selected from patients admitted to the ICUs who met the inclusion criteria. Inclusion criteria included hospitalization in the intensive care unit up to 24 hours after admission to the hospital, age 18-65 years, feeding through NG tube, patients under MV for more than 24 hours, no pregnancy, no obesity (Patients with a body mass index above 40), no liver disease and no severe infection. Exclusion criteria were: change of feeding type from gavage to complete intravenous feeding and transfer or discharge of the patient from the ICU (Figure 1). Primary outcomes were Duration of patient connection to ventilator in two groups of intervention and control, and the length of stay in intensive care unit between intervention and control groups. Secondary outcome was Serum albumin level in the intervention and control groups.
In order to start the study, informed consent was obtained from the legal guardians of the patients who met the study entry criteria. Then a history was taken from the patients and physical examination was performed by the resident doctor of the ward. Medical information and medical records patients were obtained from the treatment team and patients' files and recorded in the questionnaire and checklist. They were randomly and using a table of random numbers assigned to intervention and control groups.
In the intervention group, a Standard Entera Meal solution was used to provide energy, which had one kcal of energy per ml and the distribution of macronutrients was 14% energy from protein, 33% energy from fat and 53% energy from carbohydrates. To prepare 150 ml of the solution, 33 g (one measure) of Entera Meal was added to 120 ml of chilled boiled water, which this solution had one kcal per ml of energy. Feeding was performed using a NG tube by Bolus Infusion method with a 60-cc syringe. Start with 50 cc and add 30 cc every three hours to reach the calculated energy in 48-72 hours. The timing of the prescribed hours was as follows: 6, 9, 12, 15, 18 and 21. The amount of energy equivalent to 25 kcal per kg of body weight was considered for the first week and from the second week 30 kcal per kg of body weight was calculated.
In the control group, hospital gavage solutions were used without interfering in its preparation method which is sent to the Laboratory of Nutrition Department of Paramedical School for analysis of macronutrients and energy. Blood albumin levels were measured in both groups before and after the intervention.
Data Collection
The data collection was done by demographic and medical information questionnaire included age, sex, weight, Albumin level at the beginning and end of the study, the type of underlying disease, the reason for admission, medical records, the duration of the patient's separation from the mechanical ventilation device and Length of stay in ICU, and interventions recording checklist. The validity of demographic and medical information questionnaire and the checklist was confirmed by 15 nursing faculty members.
Statistical analysis
Data analysis was conducted using the SPSS software version 22. Quantitative variables were reported as mean, median, standard deviation, minimum and maximum, and qualitative variables were reported as frequency and percent. Independent t-test was used to compare the means if normal and otherwise Mann-Whitney test was used. The chi-square or Fisher’s exact tests were used to compare the nominal variables between the two groups.