Critical IllnessNCT06113393
The Effects of Different Gastric Residual Volume Thresholds for Holding Feeding in Internal Medicine.
A study testing GRV thresholds in people with Critical Illness, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This is a randomized control trial with a parallel design. Eligible patients will be randomly assigned into two groups: a control group which will be holding tube feeding when the GRV reaches 200 mL, and an experimental group will hold tube feeding when the GRV reaches 300 mL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- GRV thresholds
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2024to Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients admitted to the internal medicine intensive care unit.
- Patients receive enteral nutrition through a nasogastric tube.
- Patients receiving continuous enteral feeding.
Who cannot join
- Patients post-abdominal surgery.
- Patients admitted to the intensive care unit due to gastrointestinal disorders (e.g., gastrointestinal bleeding, bowel obstruction).
- Patients receiving palliative care with reduced enteral nutrition.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital
Taipei
YUN SHAN CHOU, sam573420028184@gmail.com
About this study
Official title: Comparison of the Effects of Different Gastric Residual Volume Thresholds for Holding Enteral Feeding on Nutritional Intake in Critically Ill Patients in Internal Medicine
This is a randomized control trial with a parallel design. Eligible patients will be randomly assigned into two groups: a control group which will be holding tube feeding when the GRV reaches 200 mL, and an experimental group will hold tube feeding when the GRV reaches 300 mL. Enteral feeding will be administered according to the study flow chart.
Read the detailed description
Background: Malnutrition is a common issue among critically ill patients. which increases hospital stays, costs, and mortality rate. According to the study, the primary reason for nurses to hold enteral nutrition is elevated gastric residual volume (GRV). However, there is still no consensus on the definition of high residual gastric volume, there is currently no consensus among experts and scholars regarding the threshold for holding enteral nutrition. Clinical nurses may prematurely hold enteral nutrition due to concerns regarding potential side effects such as vomiting and choking. The aim of this study is to increase the threshold for holding enteral feeding based on the results of the study, in order to improve nutritional intake in critically ill patients in internal medicine.
Objective: Increase the nutritional intake of critically ill patients in the Department of Internal Medicine by increasing the threshold for holding tube feeding.
Methods: This is a randomized control trial with a parallel design. Eligible patients will be randomly assigned into two groups: a control group which will be holding tube feeding when the GRV reaches 200 mL, and an experimental group will hold tube feeding when the GRV reaches 300 mL. Enteral feeding will be administered according to the study flow chart. The outcome data will collected based on the medical chart including frequency of diet volume ratio (diet received/diet prescribed), incidence of gastrointestinal complications, ventilator days, Ventilator-associated pneumonia, length of intensive care unit(ICU) stay, changes in nutritional indicators, APACHE Ⅱ and Duration of parenteral nutrition use.
Expected result: The results of this study will provide evidence regarding the improved effectiveness and safety of increasing the threshold of GRV in medical ICU and inform future evidence-based practice.
- Conditions
- Critical Illness
- Being tested
- GRV thresholds
- Keywords
- Enteral nutrition, Gastric residual volume
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GRV thresholdsProcedure or surgery
Hold enteral feeding when GRV reaches 200 mL(current standard)
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Hold enteral feeding when GRV reaches 200 mL(current standard) |
| study group | Experimental | Hold enteral feeding when GRV reaches 300 mL(current standard) Receives: Procedure: GRV thresholds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of diet volume ratio
Measured: 1 day (Transfer from the Intensive Care Unit)
Incidence of gastrointestinal complications
Abdominal distension, nausea, vomiting, diarrhea, constipation
Measured: 1 day (Transfer from the Intensive Care Unit)
Secondary outcomes (9)
Days of ventilator use
Measured: A week(Transfer from the Intensive Care Unit)
Ventilator-associated pneumonia
Diagnosis form clinical doctor according to chest x-ray
Measured: 1 day (Transfer from the Intensive Care Unit)
Length of stay in the intensive care unit
Measured: A week(Transfer from the Intensive Care Unit)
Days of parenteral nutrition use
Measured: A week(Transfer from the Intensive Care Unit)
Acute Physiology and Chronic Health Evaluation score
an integer score from 0 to 71 is computed based on several measurements; higher scores correspond to more severe disease and a higher risk of death.
Measured: 1 day (Transfer from the Intensive Care Unit)
Nutrition Risk Screening 2002(NRS2002)
The NRS-2002 was developed by Kondrup et al., and is meant to be a generic tool in the hospital setting-that is, useful in detecting most of the patients who would benefit from nutritional therapy. The NRS-2002 is a simple and well-validated tool that incorporates pre-screening with four questions. If one of these is answered positively, a screening follows which includes surrogate measures of nutritional status, with static and dynamic parameters and data on the severity of the disease (stress metabolism). For each parameter, a score from 0 to 3 can result. Age over 70 years is considered a risk factor and is included in the screening tool, giving 1 point. A total score of ≥3 points means that the patient is at risk of malnutrition or already malnourished.
Measured: 1 day (Transfer from the Intensive Care Unit)
Albumin in g/dL
Measured: 1 day (Transfer from the Intensive Care Unit)
C-reactive protein in mg/dl
Measured: 1 day (Transfer from the Intensive Care Unit)
Body mass index
Measured: 1 day (Transfer from the Intensive Care Unit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study startJan 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06113393
- Sponsor's protocol ID
- 202307181RINB
- Status last verified
- Oct 2023
- First submitted
- 22 Oct 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Different Gastric Residual Volume Thresholds for Holding Enteral Feeding on Nutritional Intake in Critically Ill Patients in Internal Medicine
- ClinicalTrials.gov ID
- NCT06113393
- Acronym / sponsor ID
- 202307181RINB
- Conditions
- Critical Illness
- Keywords
- Enteral nutrition, Gastric residual volume
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 2 Nov 2023 (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.
This is a randomized control trial with a parallel design. Eligible patients will be randomly assigned into two groups: a control group which will be holding tube feeding when the GRV reaches 200 mL, and an experimental group will hold tube feeding when the GRV reaches 300 mL. Enteral feeding will be administered according to the study flow chart.
Detailed description
Background: Malnutrition is a common issue among critically ill patients. which increases hospital stays, costs, and mortality rate. According to the study, the primary reason for nurses to hold enteral nutrition is elevated gastric residual volume (GRV). However, there is still no consensus on the definition of high residual gastric volume, there is currently no consensus among experts and scholars regarding the threshold for holding enteral nutrition. Clinical nurses may prematurely hold enteral nutrition due to concerns regarding potential side effects such as vomiting and choking. The aim of this study is to increase the threshold for holding enteral feeding based on the results of the study, in order to improve nutritional intake in critically ill patients in internal medicine.
Objective: Increase the nutritional intake of critically ill patients in the Department of Internal Medicine by increasing the threshold for holding tube feeding.
Methods: This is a randomized control trial with a parallel design. Eligible patients will be randomly assigned into two groups: a control group which will be holding tube feeding when the GRV reaches 200 mL, and an experimental group will hold tube feeding when the GRV reaches 300 mL. Enteral feeding will be administered according to the study flow chart. The outcome data will collected based on the medical chart including frequency of diet volume ratio (diet received/diet prescribed), incidence of gastrointestinal complications, ventilator days, Ventilator-associated pneumonia, length of intensive care unit(ICU) stay, changes in nutritional indicators, APACHE Ⅱ and Duration of parenteral nutrition use.
Expected result: The results of this study will provide evidence regarding the improved effectiveness and safety of increasing the threshold of GRV in medical ICU and inform future evidence-based practice.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Hold enteral feeding when GRV reaches 200 mL(current standard) |
| study group | Experimental | Procedure: GRV thresholdsHold enteral feeding when GRV reaches 300 mL(current standard) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients admitted to the internal medicine intensive care unit.
- Patients receive enteral nutrition through a nasogastric tube.
- Patients receiving continuous enteral feeding.
Key exclusion criteria (3 listed)
- Patients post-abdominal surgery.
- Patients admitted to the intensive care unit due to gastrointestinal disorders (e.g., gastrointestinal bleeding, bowel obstruction).
- Patients receiving palliative care with reduced enteral nutrition.
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 |
|---|---|---|
| GRV thresholdsHold enteral feeding when GRV reaches 200 mL(current standard) | Procedure or surgery | study group |
Primary outcome
Frequency of diet volume ratio
Time frame: 1 day (Transfer from the Intensive Care Unit)
Incidence of gastrointestinal complications
Time frame: 1 day (Transfer from the Intensive Care Unit)
Abdominal distension, nausea, vomiting, diarrhea, constipation
9 secondary outcomes
Days of ventilator use
Time frame: A week(Transfer from the Intensive Care Unit)
Ventilator-associated pneumonia
Time frame: 1 day (Transfer from the Intensive Care Unit)
Length of stay in the intensive care unit
Time frame: A week(Transfer from the Intensive Care Unit)
Days of parenteral nutrition use
Time frame: A week(Transfer from the Intensive Care Unit)
Acute Physiology and Chronic Health Evaluation score
Time frame: 1 day (Transfer from the Intensive Care Unit)
Nutrition Risk Screening 2002(NRS2002)
Time frame: 1 day (Transfer from the Intensive Care Unit)
Albumin in g/dL
Time frame: 1 day (Transfer from the Intensive Care Unit)
C-reactive protein in mg/dl
Time frame: 1 day (Transfer from the Intensive Care Unit)
Body mass index
Time frame: 1 day (Transfer from the Intensive Care Unit)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GRV thresholds in people with Critical Illness, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 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 2 Nov 2023. 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 Taiwan. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of diet volume ratio (time frame: 1 day (Transfer from the Intensive Care Unit)). 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 2 Nov 2023.