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Enteral Feeding IntoleranceNCT07876141

Continuous Versus Intermittent Enteral Feeding and Gastric Residual Volume in Critically Ill Patients

A study testing Continuous Enteral Feeding and Intermittent Enteral Feeding in people with Enteral Feeding Intolerance and Critical Illness, run by Viet Duc University Hospital at 1 site in Vietnam.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study will compare two commonly used methods of enteral feeding in critically ill adults: continuous feeding and intermittent feeding. The main purpose is to determine whether the amount of feeding fluid remaining in the stomach differs between the two methods. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Enteral Feeding Intolerance, Critical Illness
What is being tested?
Continuous Enteral Feeding and Intermittent Enteral Feeding
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
1 siteVietnam
Study dates
15 Oct 2026to 1 Oct 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 to 80 years.
  • Currently treated in an intensive care unit and has a clinical indication for gastric enteral nutrition through a nasogastric or orogastric tube.
  • The gastrointestinal tract is considered usable for enteral nutrition according to the treating physician.
  • Expected to remain in the intensive care unit and to be available for study follow-up for 72 hours after randomization, unless a prespecified early stopping criterion occurs.
  • A gastric enteral nutrition plan is in place; the enteral formula and energy/protein targets are determined by the treating physician in consultation with the Department of Nutrition before randomization.
  • Written informed consent is provided by the participant or a legally authorized representative.

Who cannot join

  • Previous gastrectomy, pyloric stenosis, or recent gastric or duodenal surgery that alters gastric anatomy or function and may affect ultrasound-based gastric volume estimation.
  • Contraindication to enteral nutrition, including bowel obstruction, severe ileus, gastrointestinal perforation, intestinal ischemia or necrosis, severe gastrointestinal bleeding, or another condition requiring complete cessation of enteral feeding.
  • Expected death, transfer out of the intensive care unit, or removal of the gastric tube in the near term such that 72-hour study follow-up is not feasible.
  • Receiving exclusive parenteral nutrition with no plan to initiate gastric enteral feeding.
  • Pregnancy.
  • Uncontrolled shock or hemodynamic instability at screening, defined as norepinephrine ≥0.3 micrograms/kg/min or an equivalent vasopressor requirement according to the treating physician.
Show all 10Show fewer
  • Unable to tolerate brief right lateral positioning for gastric ultrasonography because of hemodynamic or respiratory instability, spinal injury or fixation, contraindication to turning, or another safety concern.
  • Gastric antrum cannot be adequately visualized at screening because of an inadequate acoustic window, surgical wound or dressing, subcutaneous emphysema, excessive gas, or another reason.
  • Participant or legally authorized representative declines participation.
  • Participant lacks capacity to provide consent and no legally authorized representative is available at enrollment.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Thu Phuong Hoang, MD contact

+84 943 671 709

hoangthuphuongdb@gmail.com

Minh Viet Nguyen, MD contact

+84 918 292 528

vietminh1510@gmail.com

Vietnam1 site, 1 recruiting
  • Viet Duc University Hospital

    Hà Nội, 100000

    Thu Phuong Hoang, MD, +84 943 671 709, hoangthuphuongdb@gmail.com

    Thu Phuong Hoang, MD

    Recruiting

Other trials in Vietnam

About this study

Official title: Comparison of Gastric Residual Volume Between Continuous and Intermittent Enteral Feeding in Critically Ill Patients

This study will compare two commonly used methods of enteral feeding in critically ill adults: continuous feeding and intermittent feeding. The main purpose is to determine whether the amount of feeding fluid remaining in the stomach differs between the two methods.

A total of 76 participants will be randomly assigned to receive either continuous gastric feeding or intermittent gastric feeding every 4 hours. Gastric ultrasound will be performed at the bedside before starting the assigned feeding method and then every 4 hours for 72 hours. The study will also record symptoms of feeding intolerance, such as vomiting, regurgitation, abdominal distension, diarrhea, constipation, feeding interruptions, and the amount of prescribed nutrition actually delivered.

Read the detailed description

This is a single-center, prospective, open-label, parallel-group randomized controlled trial conducted in critically ill adults who require gastric enteral nutrition.

A total of 76 participants will be randomly allocated in a 1:1 ratio to continuous enteral feeding or intermittent enteral feeding. Before randomization, the treating physician, in consultation with the Department of Nutrition, will determine the enteral formula and the daily energy and protein targets for each participant. The study intervention is the method used to deliver the prescribed nutrition.

In the continuous-feeding group, the prescribed daily enteral volume will be delivered through a gastric tube using an enteral feeding pump at a stable hourly rate. In the intermittent-feeding group, the prescribed daily volume will be divided into six feeds administered every 4 hours, with each feed delivered over approximately 30 to 60 minutes.

Gastric ultrasonography will be performed at baseline before starting the assigned feeding method and every 4 hours for 72 hours. The primary outcome is the mean ultrasound-estimated gastric residual volume calculated from the 18 post-baseline measurements obtained from 4 to 72 hours. The study will also evaluate enteral feeding intolerance, vomiting or regurgitation, progressive abdominal distension, diarrhea, constipation, episodes of elevated gastric residual volume, suspected aspiration, feeding interruptions, use of prokinetic medication, and the proportion of the prescribed energy target actually delivered at 24, 48, and 72 hours.

All clinical decisions related to patient safety, including reducing, delaying, or stopping enteral feeding, will remain under the responsibility of the treating physician.

Being tested
Continuous Enteral Feeding, Intermittent Enteral Feeding
Keywords
continuous enteral feeding, intermittent enteral feeding, gastric ultrasound, gastric residual volume, feeding intolerance, antral cross-sectional area, intensive care unit, enteral nutrition
Medical subject headings
Critical Illness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Continuous Enteral FeedingOther

    The prescribed daily enteral nutrition will be delivered continuously through a gastric tube using an enteral feeding pump at a stable hourly rate. The hourly rate will be calculated as the total prescribed volume for 24 hours divided by 24.

  • Intermittent Enteral FeedingOther

    The prescribed daily enteral nutrition will be divided into six equal feeds administered through a gastric tube every 4 hours. Each feed will be administered over approximately 30 to 60 minutes.

Study groups in NCT07876141
Study groupRoleWhat they receive
Continuous Enteral FeedingExperimentalParticipants assigned to this arm will receive the prescribed daily enteral nutrition continuously through a gastric tube using an enteral feeding pump. The prescribed daily volume will be delivered at a stable hourly rate calculated as the total prescribed volume for 24 hours divided by 24.
Receives: Other: Continuous Enteral Feeding
Intermittent Enteral FeedingActive comparatorParticipants assigned to this arm will receive the prescribed daily enteral nutrition through a gastric tube in six intermittent feeds administered every 4 hours. The prescribed daily volume will be divided equally among the six feeds, and each feed will be administered over approximately 30 to 60 minutes.
Receives: Other: Intermittent Enteral Feeding

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Ultrasound-Estimated Gastric Residual Volume Over 72 Hours

    Mean ultrasound-estimated gastric residual volume (GRV), in milliliters (mL). For each participant, the primary endpoint will be calculated as the arithmetic mean of 18 post-baseline GRV measurements obtained every 4 hours from 4 hours through 72 hours after initiation of the assigned feeding strategy. The baseline measurement obtained before initiation of the assigned feeding strategy will not be included in this mean. Gastric antral cross-sectional area (CSA) will be calculated as AP × CC × π/4, where AP is the anteroposterior diameter and CC is the craniocaudal diameter. GRV will be estimated using the Perlas formula: GRV (mL) = 27.0 + 14.6 × CSA (cm²) - 1.28 × age (years). Calculated values below 0 mL will be set to 0 mL.

    Measured: From 4 hours after initiation of the assigned feeding strategy through 72 hours

Secondary outcomes (14)
  1. Participants With at Least One GRV >250 mL

    Number and percentage of participants with at least one ultrasound-estimated gastric residual volume (GRV) measurement greater than 250 mL during post-baseline follow-up.

    Measured: From 4 hours after initiation of the assigned feeding strategy through 72 hours

  2. Participants With at Least One GRV >500 mL

    Number and percentage of participants with at least one ultrasound-estimated gastric residual volume (GRV) measurement greater than 500 mL during post-baseline follow-up.

    Measured: From 4 hours after initiation of the assigned feeding strategy through 72 hours

  3. Enteral Feeding Intolerance

    Number and percentage of participants with at least one gastrointestinal manifestation that causes the treating physician to reduce, delay, or temporarily interrupt enteral feeding and/or to initiate supportive treatment.

    Measured: From randomization through 72 hours

  4. Vomiting or Regurgitation

    Number and percentage of participants with at least one episode of vomiting or regurgitation documented by clinical staff during enteral feeding.

    Measured: From randomization through 72 hours

  5. Progressive Abdominal Distension

    Number and percentage of participants with new-onset abdominal distension or an increase in abdominal distension compared with the previous clinical assessment, as documented by a physician or nurse.

    Measured: From randomization through 72 hours

  6. Diarrhea

    Number and percentage of participants with diarrhea, defined as at least 3 episodes of loose stool within 24 hours or a diagnosis of diarrhea by the treating physician.

    Measured: From randomization through 72 hours

  7. Constipation

    Number and percentage of participants with constipation, defined as no bowel movement for at least 3 days or the need for therapeutic intervention for constipation during follow-up.

    Measured: From randomization through 72 hours

  8. Suspected Pulmonary Aspiration

    Number and percentage of participants with at least one clinically suspected pulmonary aspiration event documented by the treating team during enteral feeding.

    Measured: From randomization through 72 hours

  9. Number of Enteral Feeding Reduction or Interruption Episodes

    Number of episodes in which enteral feeding is reduced or temporarily interrupted during the 72-hour follow-up. The reason for each episode will be recorded.

    Measured: From randomization through 72 hours

  10. Total Duration of Enteral Feeding Interruption

    Total cumulative duration, in minutes, during which enteral feeding is temporarily interrupted during the 72-hour follow-up.

    Measured: From randomization through 72 hours

  11. New Use of a Prokinetic Agent

    Number and percentage of participants newly started on a prokinetic agent, such as metoclopramide or erythromycin, after randomization because of feeding intolerance or impaired gastric emptying.

    Measured: From randomization through 72 hours

  12. Percentage of Prescribed Energy Target Achieved at 24 Hours

    Percentage of the prescribed energy target actually delivered during the first 24 hours, calculated as cumulative actual enteral energy delivered divided by the cumulative prescribed enteral energy target for the same period, multiplied by 100.

    Measured: At 24 hours

  13. Percentage of Prescribed Energy Target Achieved at 48 Hours

    Percentage of the prescribed energy target actually delivered through 48 hours, calculated as cumulative actual enteral energy delivered divided by the cumulative prescribed enteral energy target for the same period, multiplied by 100.

    Measured: At 48 hours

  14. Percentage of Prescribed Energy Target Achieved at 72 Hours

    Percentage of the prescribed energy target actually delivered through 72 hours, calculated as cumulative actual enteral energy delivered divided by the cumulative prescribed enteral energy target for the same period, multiplied by 100.

    Measured: At 72 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2026
  2. Study start15 Oct 2026
  3. Primary completion1 Oct 2027 (estimated)
  4. Study completion1 Oct 2027 (estimated)

Resources

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
Masking
None (open label)
Enrolment
76 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07876141
Sponsor's protocol ID
PhuongK2
Other IDs
HMUIRB2962
Status last verified
Oct 2026
First submitted
6 Oct 2026
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared outside the approved research team. Study results will be reported in aggregate form without direct identifiers.

Publications

  • Ankalagi B, Singh PM, Rewari V, Ramachandran R, Aggarwal R, Soni KD, Das D, Madhusudhan KS, Srivastava DN, Kaur M, Trikha A. Serial Ultrasonographic-measurement of Gastric Residual Volume in Critically Ill Patients for Prediction of Gastric Tube Feed Intolerance. Indian J Crit Care Med. 2022 Sep;26(9):987-992. doi: 10.5005/jp-journals-10071-24296.

    PubMed 36213700
  • Sharma V, Gudivada D, Gueret R, Bailitz J. Ultrasound-Assessed Gastric Antral Area Correlates With Aspirated Tube Feed Volume in Enterally Fed Critically Ill Patients. Nutr Clin Pract. 2017 Apr;32(2):206-211. doi: 10.1177/0884533616681530. Epub 2016 Dec 16.

    PubMed 28362573
  • Hamada SR, Garcon P, Ronot M, Kerever S, Paugam-Burtz C, Mantz J. Ultrasound assessment of gastric volume in critically ill patients. Intensive Care Med. 2014 Jul;40(7):965-72. doi: 10.1007/s00134-014-3320-x. Epub 2014 May 20.

    PubMed 24841699
  • Perlas A, Mitsakakis N, Liu L, Cino M, Haldipur N, Davis L, Cubillos J, Chan V. Validation of a mathematical model for ultrasound assessment of gastric volume by gastroscopic examination. Anesth Analg. 2013 Feb;116(2):357-63. doi: 10.1213/ANE.0b013e318274fc19. Epub 2013 Jan 9.

    PubMed 23302981
  • Lee HY, Lee JK, Kim HJ, Ju DL, Lee SM, Lee J. Continuous versus Intermittent Enteral Tube Feeding for Critically Ill Patients: A Prospective, Randomized Controlled Trial. Nutrients. 2022 Feb 4;14(3):664. doi: 10.3390/nu14030664.

    PubMed 35277023
  • Heffernan AJ, Talekar C, Henain M, Purcell L, Palmer M, White H. Comparison of continuous versus intermittent enteral feeding in critically ill patients: a systematic review and meta-analysis. Crit Care. 2022 Oct 25;26(1):325. doi: 10.1186/s13054-022-04140-8.

    PubMed 36284334

Questions about this trial

What is this clinical trial studying?

A study testing Continuous Enteral Feeding and Intermittent Enteral Feeding in people with Enteral Feeding Intolerance and Critical Illness, run by Viet Duc University Hospital at 1 site in Vietnam.

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 6 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 19 Oct 2026. 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 Vietnam. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Thu Phuong Hoang, MD (+84 943 671 709, hoangthuphuongdb@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Ultrasound-Estimated Gastric Residual Volume Over 72 Hours (time frame: From 4 hours after initiation of the assigned feeding strategy through 72 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07876141, which also lists 6 linked publications.

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 19 Oct 2026.

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