Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Brno University Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to compare continuous versus intermittent strategy for enteral nutrition. The study will examine if there is a difference in achieving nutritional delivery goals, tolerance and number of complications of enteral nutrition.
The study will commence following the Approval by The Ethics Research Committee. All patients admitted to our ICU from the 1st of June 2018 to the 31st of May 2019 will be enrolled after fulfilling the inclusion criteria and in the absence of any exclusion criteria. Informed consent will be requested. Enteral nutrition will be administered via nasogastric of orogastric tube. Patients will be randomised in 2 groups. In the group of patients receiving continuous feeding will be enteral nutrition administered via enteral feeding pump for at least 16 hours par day. In the group of patients receiving intermittent feeding will be enteral nutrition administered as 30-60minutes lasting bolus via enteral feeding pump 6 times per day. Following the administration of the bolus the patient will be placed for 30 minutes in semi-upright sitting position. Enteral nutrition requirement and composition will be standardised with the adoption of international guidelines. In 5 subsequent days from the enteral nutrition commencement will be examined if there is a difference in achieving energy and protein targets, tolerance and number of complications of enteral nutrition in between both groups. As achievement of energy and protein targets will be considered at least 80% of calculated values. The tolerance of enteral nutrition will be evaluated by the clinical examination of the abdomen, presence of diarrhoea, vomiting and the gastric residual volume of at least 0,5 liter. As the complications of enteral nutrition will be regarded the aspiration of gastric contents and ventilator associated pneumonia. Nutritional status parameters will be analysed. the length of hospital stay, ICU length of stay and 28-day mortality will be also monitored.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intermittent | Experimental | enteral nutrition will be administered via enteral feeding pump as 30-60minutes lasting bolus 6 times per day volume of initial bolus will be 80ml. The volume of bolus will be increased gradually according to tolerance, till the estimated target rate will be reached |
|
| Continuous | Experimental | enteral nutrition will be administered via enteral feeding pump for at least 16 hours par day initial rate will be 25ml/hour. The rate will be increased gradually according to tolerance, till the estimated target rate will be reached |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enteral nutrition | Other | administration of enteral nutrition |
|
| Measure | Description | Time Frame |
|---|---|---|
| Energy target | Daily assessment of energy intake in critically ill patients with enteral nutrition.Energy target will be achieved if at least 80% of calculated energy intake will be delivered. | 5 days from initiation of enteral nutrition |
| Measure | Description | Time Frame |
|---|---|---|
| Protein target | Daily assessment of protein intake in critically ill patients with enteral nutrition.Protein target will be achieved if at least 80% of calculated protein intake will be delivered. | 5 days from initiation of enteral nutrition |
| Tolerance of enteral nutrition |
| Measure | Description | Time Frame |
|---|---|---|
| ICU and hospital length of stay | through study completion, an average of 3 weeks | |
| 28-day mortality | 28 days from randomisation |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ondrej Hrdy, MD | Contact | +420 532 232 305 | Hrdy.Ondrej@fnbrno.cz | |
| Robert Vach, MD | Contact | +420 532 233 850 | Vach.Robert@fnbrno.cz |
| Name | Affiliation | Role |
|---|---|---|
| Roman Gal, prof MD PhD | Masaryk University Brno | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Brno and Masaryk University Brno | Recruiting | Brno | 62500 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33228772 | Derived | Hrdy O, Vrbica K, Strazevska E, Suk P, Souckova L, Stepanova R, Sas I, Gal R. Comparison of continuous versus intermittent enteral nutrition in critically ill patients (COINN): study protocol for a randomized comparative effectiveness trial. Trials. 2020 Nov 23;21(1):955. doi: 10.1186/s13063-020-04866-2. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D053717 | Pneumonia, Ventilator-Associated |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D000077299 | Healthcare-Associated Pneumonia |
| D003428 | Cross Infection |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D004750 | Enteral Nutrition |
| ID | Term |
|---|---|
| D005248 | Feeding Methods |
| D013812 | Therapeutics |
| D018529 | Nutritional Support |
| D044623 | Nutrition Therapy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Measurement of the gastric residual volume |
| 5 days from initiation of enteral nutrition |
| Tolerance of enteral nutrition | Incidence of diarrhoea | 5 days from initiation of enteral nutrition |
| Tolerance of enteral nutrition | Incidence of vomiting | 5 days from initiation of enteral nutrition |
| Complications of enteral nutrition | Incidence of aspiration and ventilator associated pneumonia | 5 days from initiation of enteral nutrition |
| Nutritional status | Blood test : total serum protein test | On admission and day 5 from initiation of enteral nutrition |
| Nutritional status | Blood test : albumin test | On admission and day 5 from initiation of enteral nutrition |
| Nutritional status | Blood test : prealbumin test | On admission and day 5 from initiation of enteral nutrition |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |