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IRCT20100124003146N10 IRCT 2022-07-19 Kashan University of Medical Sciences Comparison of two methods of bowel feeding and continuous in intensive care patients Comparison of the effect of two methods of bolus and continuous enteral feeding on biochemical and clinical indicators of trauma patients admitted to intensive care units 2022-07-23 anticipated 74 Complete https://irct.ir/trial/63673 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the block randomization method was used in blocks 4 and 6, which were prepared using the online randomization software (www.sealedenvelope.com). In this software, two groups A (continuous feeding group) and B (bolus feeding group) were defined. Then, according to the total number of samples, which was 74, to increase the validity of randomization, two blocks of 6 and 4 blocks were defined with the approval of a statistician.Then, the researcher will be present in the section and will put the samples with the word criteria into groups based on the list obtained from the randomization software, Blinding description: In this study, nurses will only be aware of the type of gavage for the patient, but will not know which patient is in the experimental group and which patient is in the control group. Also, the person who collects the study data and the person who will analyze them will not know the names of the groups and only the names of the groups will be marked with the letters A and B. N/A Condition 1: Nutritional support in intensive care. Condition 2: Nutritional support in intensive care. Intervention 1: The enteral nutrition group will be the intervention group in a continuous manner. In the intervention group, enteral feeding will be done continuously (for 24 hours and in the form of an infusion of 20 drops per minute, which will be 2000 cc for a total of 24 hours). The food item (Karen's Standard Intermeal powder) will be prepared and given by the nutrition expert in a standard way for both groups in the same volume every 24 hours. The duration of intervention in both groups will last seven days. Intervention 2: The control group will be given enteral feeding in the form of bolus using a gavage syringe and under gravity every 3 hours, 250 cc of food will be given in 10 to 20 minutes, for a total of 24 hours of 2000 cc of standard Intrameal solution dissolved by a nutritionist. , will be given. The food item (Karen's Standard Intermeal powder) which will be prepared and given by the nutrition expert in a standard way for both groups in the same volume every 24 hours. The duration of intervention in both groups will last seven days. Yes - There is a plan to make this available What will be shared: the results related to the main outcome will be distributed When: after the publication of the article To whom: All people Conditions: data will be confidential Where to obtain: azizifinies@yahoo.com How to obtain: En the process will be announced later Comments:
public Ismail Azizi-Fini
5Th Kilometer Qotb Ravandi blouvar.kashan university of medical sciences
Kashan Iran (Islamic Republic of) 8715981151 +98 31 5554 0021 azizifinies@yahoo.com Kashan University of Medical Sciences scientific Ismail Azizi-Fini
5th kilometer Qotb Ravandi Blouvar
Kashan Iran (Islamic Republic of) 8715981151 +98 31 5554 0021 azizifinies@yahoo.com Kashan University of Medical Sciences Iran (Islamic Republic of) Being hospitalized in the intensive care unit Intestinal feeding through the nasogastric tube is prescribed by a doctor Have stable and normal hemodynamic conditions. The patient has a head trauma. 18 years 60 years Both Age over 60 years The patient has intravenous nutrition The patient has a kidney or liver disorder E43 J98.4 Unspecified severe protein-calorie malnutrition Other disorders of lung Treatment - Other Treatment - Other The enteral nutrition group will be the intervention group in a continuous manner. In the intervention group, enteral feeding will be done continuously (for 24 hours and in the form of an infusion of 20 drops per minute, which will be 2000 cc for a total of 24 hours). The food item (Karen's Standard Intermeal powder) will be prepared and given by the nutrition expert in a standard way for both groups in the same volume every 24 hours. The duration of intervention in both groups will last seven days. The control group will be given enteral feeding in the form of bolus using a gavage syringe and under gravity every 3 hours, 250 cc of food will be given in 10 to 20 minutes, for a total of 24 hours of 2000 cc of standard Intrameal solution dissolved by a nutritionist. , will be given. The food item (Karen's Standard Intermeal powder) which will be prepared and given by the nutrition expert in a standard way for both groups in the same volume every 24 hours. The duration of intervention in both groups will last seven days. Remaining volume in the stomach. Timepoint: Daily. Method of measurement: Gavage syringe(50 cc). Level of Albumin. Timepoint: Before intervention, 3 and 7 days after intervention. Method of measurement: Blood biochemistry test device. Number of intestinal excretions. Timepoint: daily. Method of measurement: checklist. Occurrence of pulmonary aspiration. Timepoint: daily. Method of measurement: checklist. Number of vomiting. Timepoint: daily. Method of measurement: checklist. Stomach bleeding. Timepoint: daily. Method of measurement: checklist. Total blood protein level. Timepoint: Before intervention, 3 and 7 days after intervention. Method of measurement: Blood biochemistry test device. White blood cell level. Timepoint: Before intervention, 3 and 7 days after intervention. Method of measurement: Blood analyzer. Whole blood lymphocyte count. Timepoint: Before intervention, 3 and 7 days after intervention. Method of measurement: Blood analyzer. Blood hemoglobin level. Timepoint: Before intervention, 3 and 7 days after intervention. Method of measurement: Blood analyzer. Hematocrit level. Timepoint: Before intervention, 3 and 7 days after intervention. Method of measurement: Blood analyzer. Blood urea level. Timepoint: Before intervention, 3 and 7 days after intervention. Method of measurement: Blood biochemistry test device. Blood creatinine level. Timepoint: Before intervention, 3 and 7 days after intervention. Method of measurement: Blood biochemistry device. Blood calcium level. Timepoint: Before intervention, 3 and 7 days after intervention. Method of measurement: Blood biochemistry device. Blood phosphorus level. Timepoint: Before intervention, 3 and 7 days after intervention. Method of measurement: Blood biochemistry device. Blood phosphorus level. Timepoint: Before intervention, 3 and 7 days after intervention. Method of measurement: Blood biochemistry device. Blood cholesterol level. Timepoint: Before intervention, 3 and 7 days after intervention. Method of measurement: Blood biochemistry device. Blood triglyceride levels. Timepoint: Before intervention, 3 and 7 days after intervention. Method of measurement: Blood biochemistry device. Blood aspartate aminotransferase level. Timepoint: Before intervention, 3 and 7 days after intervention. Method of measurement: Blood biochemistry device. Weaning from the ventilator. Timepoint: End of intervention. Method of measurement: Checklist. Kashan University of Medical Sciences Approved 2022-05-16 Ethics Committee of the Faculty of Nursing and Midwifery, Health and Paramedicine - Kashan Universit 5th kilometer Qotb Ravandi blouvar kashan Isfehan Iran (Islamic Republic of)