ComplicationNCT04576234
Comparative Study Between Two Routes of Enteral Feeding
A study testing entral feeding in people with Complication, run by Sarah Asmaa at 1 site in Egypt.
Trial summary
The study assess, evaluate and compare the efficacy of two methods of enteral feeding on complications and nutritional status among ICU patients. The study had utilized two methods of enteral feeding consisted of intermittent enteral feeding by syringe pump and hospital blended enteral feeding by feeding bag and… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Complication
- What is being tested?
- entral feeding
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Sep 2020to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age of 18 - 60 years.
- patients of both genders.
- patients with a functional gastrointestinal tract and poor oral nutritional intake.
Who cannot join
- patients for whom par-enteral nutrition would be more suitable.
- patients wit GIT obstruction or fistula.
- patients with ischemic bowel.
- patients in whom enteral feeding access is not available
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between the Effect of Intermittent Enteral Feeding by Syringe Pump and Hospital Blended Enteral Feeding by Feeding Bag on Complications and Nutritional Status Among ICU Patients.
The study assess, evaluate and compare the efficacy of two methods of enteral feeding on complications and nutritional status among ICU patients.
The study had utilized two methods of enteral feeding consisted of intermittent enteral feeding by syringe pump and hospital blended enteral feeding by feeding bag and assess the patient before and after feeding for 10 days by using three tools help to monitor hemodynamic parameters, GIT system assessment and laboratory findings assessment which help to evaluate nutritional status and complications. The results showed that the complications in the intermittent enteral feeding group were lower than those in feeding bag group.
Read the detailed description
Introduction Enteral nutritional support refers to the provision of calories, protein, electrolytes, vitamins, minerals, trace elements, and fluids via the gastrointestinal route. Enteral feeding is indicated for patients with a functional gastrointestinal tract whose oral nutritional intake is insufficient to meet estimated needs .
Enteral nutrition therapy has a number of advantages over par-enteral nutrition in the management of patients requiring nutritional support. Enteral nutrition aids in the preservation of gastrointestinal function by the provision of enteral nutrients and is easier, safer and less costly to administer .
However, despite these relative advantages, the delivery of safe and effective enteral nutrition therapy may still present challenges for families and caregivers in terms of time, technical expertise, and cost .
Due to advances in technology of enteral feeding tubes and delivery systems, specialization of health professionals, and better education of parents and caregivers, the administration of enteral nutrition has been associated with improved clinical outcome and safety profiles. Enteral nutrition therapy is easier and safer to administer than is par-enteral nutrition. Not only are the risks of intravenous access avoided, but there is also a wider margin for error with most metabolic complications. As a result, enteral nutrition therapy is easier to administer in low-intensity hospitals and patient care settings, including the home. However, compared with normal diet, tube feedings require extra time and effort to administer and this additional care need may contribute to increased burden and stress for families and caregivers .
This study was designed as a randomized controlled trial to compare the effect of intermittent enteral feeding by using syringe pump versus hospital blended feeding by using feeding bag on the nutritional status and complications among ICU patients.
Methods Design Structured as a randomized-controlled prospective study, the objective of this study was to compare the efficacy of intermittent enteral feeding by using syringe pump versus hospital blended formula by using feeding bag on reducing complications and improving the nutritional status of patients the intensive care units.
Setting Data was collected from assiut university hospitals .
Sample The study population consisted of patients eighteen to sixty years old, hospitalized and treated in critical and trauma intensive care units. The inclusion criteria stipulated that the patient was between eighteen and sixty years old; both genders were included; patients with a functional gastrointestinal tract and poor oral nutritional intake and agreed to participate in the study. A power calculation estimated that in order to detect an effect size of 11.8 difference in mean of protein level between the two studied groups, with a p-value < 0.05 and 80% power, confidence level 0.95, a sample size of 22 patients for each group was needed. However, 60 patients were attempted in this research work to avoid non-response rate (30 for each group). This calculated using G Power 3.1 . The study data was collected between June 2019 and December 2019.
Instruments and measurements Three tools used in this study were developed by the researcher based on reviewing of the literature. The first tool was general assessment sheet used to monitor hemodynamic parameters included (Mean arterial pressure (MAP) taken from bed side monitor, heart rate (HR), temperature, respiratory rate and CVP readings, physical examination done every day and included neurological examination and chest examination regarding disturbances, chest x-ray assessment, mode of ventilation and duration of mechanical ventilation, fluid balance assessment., assessment of laboratory findings in addition to socio-demographic and medical data.
The second tool is feeding assessment sheet was developed by the researcher and used to assess BMI after assessing height and weight; assessment of amount of water, protein, calories was given per day; assessment of mode of enteral feeding ; residual volume assessment; period of feeding rest and frequency .
The third tool is Patients' outcomes evaluation sheet which was developed by the researcher and used to assess patients' outcomes and complications . .
Intervention After getting ethical clearance patients were enrolled in the study, patients were selected based on the inclusion and exclusion criteria. Following an initial assessment, the patients were assigned to one of the two groups by block randomization.
Both groups received 3000 ml of feed per day and the same formula per day which was 30-35 ml/kg of water, 0.8 g/kg of protein and 2000 k cal of calories for females and 2500 K cal for males. The only manipulation was in the flow rate and the device which the feed was administered.
Intermittent enteral feeding group received intermittent feeding as the feed was given over a 24 hour period with intervals of rest (e.g. three hours feeding two hours rest) by using syringe pump and Feeds were administered according to guidelines as the head of the patient's bed was elevated at least 30 degrees from the horizontal before initiating feeding, the feeding schedule was started at a rate of 50 ml/hr in adults to promote tolerance,the administration rate of isotonic formulas increased in 20-25 ml/hr increments every eight hours until the desired rate was achieved, the tube was flushed regularly with 20 to 30 ml of warm water every four hours during continuous feeding and before and after intermittent feeding and medication administration, the gastric residual volume was checked every 4-6 hr routinely Feeding bag group received hospital blended formula which was 300 ml of feeds every 24 hrs with 4 hrs rest at night and given in 10 minutes with following the same guidelines in the intermittent enteral feeding group.
Data collection The data were collected from the first day of admission after stabilization of the patient's condition and extended to 7 days, every day then the data were recorded in the developed tools.The researcher assigned study sample (30 patients) to two groups (intermittent enteral feeding group, feeding bag group).
For intermittent enteral feeding group: The researcher assessed patients who were receiving intermittent enteral feeding. For feeding bag group: The researcher assessed patients who received hospital blended formula.
Ethical considerations Approval for the study was obtained from the Ethics Committee of the faculty of nursing with no risk for study subject during application of the study as the study followed common ethical principles in clinical research and written consent was obtained from patients or guidance that participated in the study after explaining the nature and purpose of the study.
Patient was assured that the data of this research was not be reused without second permission, confidentiality and anonymity was assured and the patients had the right to refuse to participate or withdraw from the study without any rational at any time.
.
- Conditions
- Complication
- Being tested
- entral feeding
- Keywords
- intermittent enteral feeding, hospital blended feeding, complications, nutritional status
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
entral feedingDietary supplement
Intermittent enteral feeding group recieved intermittent feeding as the feed was given over a 24 hour period with intervals of rest (e.g. three hours feeding two hours rest)
| Study group | Role | What they receive |
|---|---|---|
| intermittent entral feeding group | Experimental | Intermittent enteral feeding group recieved intermittent feeding as the feed was given over a 24 hour period with intervals of rest (e.g. three hours feeding two hours rest) by using syringe pump and Feeds were administered according to guidelines as the head of the patient's bed was elevated at least 30 degrees from the horizontal before initiating feeding, the feeding schedule was started at a rate of 50 ml/hr in adults to promote tolerance,the administration rate of isotonic formulas increased in 20-25 ml/hr increments every eight hours until the desired rate was achieved, the tube was flushed regularly with 20 to 30 ml of warm water every four hours during continuous feeding and before and after intermittent feeding and medication administration, the gastric residual volume was checked every 4-6 hr routinely Receives: Dietary Supplement: entral feeding |
| , feeding bag group | Experimental | Feeding bag group received hospital blended formual which was 300 ml of feeds every 2hrs with 4hrs rest at night and given in 10 minutes with following the same guidelines in the intermittent enteral feeding group Receives: Dietary Supplement: entral feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in serum protein level
by using serum protein test which will be assessed daily, there will be change in the serum protein level to the normal value
Measured: for 10 days
change in the rate of complications
by using evaluation outcomes tool , complications will be assessed 3 times through the study
Measured: for 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start30 Sep 2020 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After getting ethical clearance; patients were enrolled in the study, patients were selected based on the inclusion and exclusion criteria. Following an initial assessment, the patients were assigned to one of the two groups by block randomization. Both groups received 3000 ml of feed per day and the same formula per day which was 30-35ml/kg of water, 0.8 g/kg of protein and 2000 kcal of calories for females and 2500 Kcal for males. The only manipulation was in the flow rate and the device which the feed was administred.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sarah Asmaa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sarah Asmaa, Assiut University
- Investigators
- Amal A Mohamed, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04576234
- Sponsor's protocol ID
- enteral feeding
- Other IDs
- sasmaa, Mostafa Samy
- Status last verified
- Sep 2020
- First submitted
- 29 Aug 2020
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between the Effect of Intermittent Enteral Feeding by Syringe Pump and Hospital Blended Enteral Feeding by Feeding Bag on Complications and Nutritional Status Among ICU Patients.
- ClinicalTrials.gov ID
- NCT04576234
- Acronym / sponsor ID
- enteral feeding
- Conditions
- Complication
- Keywords
- intermittent enteral feeding, hospital blended feeding, complications, nutritional status
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sarah AsmaaUniversity, hospital or other
- Study start
- 30 Sep 2020 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 6 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study assess, evaluate and compare the efficacy of two methods of enteral feeding on complications and nutritional status among ICU patients.
The study had utilized two methods of enteral feeding consisted of intermittent enteral feeding by syringe pump and hospital blended enteral feeding by feeding bag and assess the patient before and after feeding for 10 days by using three tools help to monitor hemodynamic parameters, GIT system assessment and laboratory findings assessment which help to evaluate nutritional status and complications. The results showed that the complications in the intermittent enteral feeding group were lower than those in feeding bag group.
Detailed description
Introduction Enteral nutritional support refers to the provision of calories, protein, electrolytes, vitamins, minerals, trace elements, and fluids via the gastrointestinal route. Enteral feeding is indicated for patients with a functional gastrointestinal tract whose oral nutritional intake is insufficient to meet estimated needs .
Enteral nutrition therapy has a number of advantages over par-enteral nutrition in the management of patients requiring nutritional support. Enteral nutrition aids in the preservation of gastrointestinal function by the provision of enteral nutrients and is easier, safer and less costly to administer .
However, despite these relative advantages, the delivery of safe and effective enteral nutrition therapy may still present challenges for families and caregivers in terms of time, technical expertise, and cost .
Due to advances in technology of enteral feeding tubes and delivery systems, specialization of health professionals, and better education of parents and caregivers, the administration of enteral nutrition has been associated with improved clinical outcome and safety profiles. Enteral nutrition therapy is easier and safer to administer than is par-enteral nutrition. Not only are the risks of intravenous access avoided, but there is also a wider margin for error with most metabolic complications. As a result, enteral nutrition therapy is easier to administer in low-intensity hospitals and patient care settings, including the home. However, compared with normal diet, tube feedings require extra time and effort to administer and this additional care need may contribute to increased burden and stress for families and caregivers .
This study was designed as a randomized controlled trial to compare the effect of intermittent enteral feeding by using syringe pump versus hospital blended feeding by using feeding bag on the nutritional status and complications among ICU patients.
Methods Design Structured as a randomized-controlled prospective study, the objective of this study was to compare the efficacy of intermittent enteral feeding by using syringe pump versus hospital blended formula by using feeding bag on reducing complications and improving the nutritional status of patients the intensive care units.
Setting Data was collected from assiut university hospitals .
Sample The study population consisted of patients eighteen to sixty years old, hospitalized and treated in critical and trauma intensive care units. The inclusion criteria stipulated that the patient was between eighteen and sixty years old; both genders were included; patients with a functional gastrointestinal tract and poor oral nutritional intake and agreed to participate in the study. A power calculation estimated that in order to detect an effect size of 11.8 difference in mean of protein level between the two studied groups, with a p-value < 0.05 and 80% power, confidence level 0.95, a sample size of 22 patients for each group was needed. However, 60 patients were attempted in this research work to avoid non-response rate (30 for each group). This calculated using G Power 3.1 . The study data was collected between June 2019 and December 2019.
Instruments and measurements Three tools used in this study were developed by the researcher based on reviewing of the literature. The first tool was general assessment sheet used to monitor hemodynamic parameters included (Mean arterial pressure (MAP) taken from bed side monitor, heart rate (HR), temperature, respiratory rate and CVP readings, physical examination done every day and included neurological examination and chest examination regarding disturbances, chest x-ray assessment, mode of ventilation and duration of mechanical ventilation, fluid balance assessment., assessment of laboratory findings in addition to socio-demographic and medical data.
The second tool is feeding assessment sheet was developed by the researcher and used to assess BMI after assessing height and weight; assessment of amount of water, protein, calories was given per day; assessment of mode of enteral feeding ; residual volume assessment; period of feeding rest and frequency .
The third tool is Patients' outcomes evaluation sheet which was developed by the researcher and used to assess patients' outcomes and complications . .
Intervention After getting ethical clearance patients were enrolled in the study, patients were selected based on the inclusion and exclusion criteria. Following an initial assessment, the patients were assigned to one of the two groups by block randomization.
Both groups received 3000 ml of feed per day and the same formula per day which was 30-35 ml/kg of water, 0.8 g/kg of protein and 2000 k cal of calories for females and 2500 K cal for males. The only manipulation was in the flow rate and the device which the feed was administered.
Intermittent enteral feeding group received intermittent feeding as the feed was given over a 24 hour period with intervals of rest (e.g. three hours feeding two hours rest) by using syringe pump and Feeds were administered according to guidelines as the head of the patient's bed was elevated at least 30 degrees from the horizontal before initiating feeding, the feeding schedule was started at a rate of 50 ml/hr in adults to promote tolerance,the administration rate of isotonic formulas increased in 20-25 ml/hr increments every eight hours until the desired rate was achieved, the tube was flushed regularly with 20 to 30 ml of warm water every four hours during continuous feeding and before and after intermittent feeding and medication administration, the gastric residual volume was checked every 4-6 hr routinely Feeding bag group received hospital blended formula which was 300 ml of feeds every 24 hrs with 4 hrs rest at night and given in 10 minutes with following the same guidelines in the intermittent enteral feeding group.
Data collection The data were collected from the first day of admission after stabilization of the patient's condition and extended to 7 days, every day then the data were recorded in the developed tools.The researcher assigned study sample (30 patients) to two groups (intermittent enteral feeding group, feeding bag group).
For intermittent enteral feeding group: The researcher assessed patients who were receiving intermittent enteral feeding. For feeding bag group: The researcher assessed patients who received hospital blended formula.
Ethical considerations Approval for the study was obtained from the Ethics Committee of the faculty of nursing with no risk for study subject during application of the study as the study followed common ethical principles in clinical research and written consent was obtained from patients or guidance that participated in the study after explaining the nature and purpose of the study.
Patient was assured that the data of this research was not be reused without second permission, confidentiality and anonymity was assured and the patients had the right to refuse to participate or withdraw from the study without any rational at any time.
.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- After getting ethical clearance; patients were enrolled in the study, patients were selected based on the inclusion and exclusion criteria. Following an initial assessment, the patients were assigned to one of the two groups by block randomization. Both groups received 3000 ml of feed per day and the same formula per day which was 30-35ml/kg of water, 0.8 g/kg of protein and 2000 kcal of calories for females and 2500 Kcal for males. The only manipulation was in the flow rate and the device which the feed was administred.
| Arm | Type | Receives |
|---|---|---|
| intermittent entral feeding group | Experimental | Dietary Supplement: entral feedingIntermittent enteral feeding group recieved intermittent feeding as the feed was given over a 24 hour period with intervals of rest (e.g. three hours feeding two hours rest) by using syringe pump and Feeds were administered according to guidelines as the head of the patient's bed was elevated at least 30 degrees from the horizontal before initiating feeding, the feeding schedule was started at a rate of 50 ml/hr in adults to promote tolerance,the administration rate of isotonic formulas increased in 20-25 ml/hr increments every eight hours until the desired rate was achieved, the tube was flushed regularly with 20 to 30 ml of warm water every four hours during continuous feeding and before and after intermittent feeding and medication administration, the gastric residual volume was checked every 4-6 hr routinely |
| , feeding bag group | Experimental | Dietary Supplement: entral feedingFeeding bag group received hospital blended formual which was 300 ml of feeds every 2hrs with 4hrs rest at night and given in 10 minutes with following the same guidelines in the intermittent enteral feeding group |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age of 18 - 60 years.
- patients of both genders.
- patients with a functional gastrointestinal tract and poor oral nutritional intake.
Key exclusion criteria (4 listed)
- patients for whom par-enteral nutrition would be more suitable.
- patients wit GIT obstruction or fistula.
- patients with ischemic bowel.
- patients in whom enteral feeding access is not available
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| entral feedingIntermittent enteral feeding group recieved intermittent feeding as the feed was given over a 24 hour period with intervals of rest (e.g. three hours feeding two hours rest) | Dietary supplement | , feeding bag group, intermittent entral feeding group |
Primary outcome
change in serum protein level
Time frame: for 10 days
by using serum protein test which will be assessed daily, there will be change in the serum protein level to the normal value
change in the rate of complications
Time frame: for 10 days
by using evaluation outcomes tool , complications will be assessed 3 times through the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amal A Mohamed principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing entral feeding in people with Complication, run by Sarah Asmaa at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asmaa Al Mahgoub, A professor (01016338015 ext. 01021759992, Asmaa_sara16@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in serum protein level (time frame: for 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2020.