Gastric Residual Volume Measurement in the Intensive Care Unit

NCT ID: NCT05238051

Last Updated: 2022-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2022-01-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Nutritional support is considered a key component of the treatment strategy for intensive care patients. Malnutrition, energy protein, and inadequate or excessive intake of other nutrients have measurable effects on tissues, body structure, body function, and clinical outcomes of patients receiving treatment. It increases hospital-acquired infections, hospitalizations, and intensive care prolongs and leads to complications. This study aimed to observe the time to reach target calories, nutritional failures, and complications during feeding in measured and unmeasured gastric residual volume patients receiving enteral nutrition under ventilation in the intensive care unite.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Preventing Malnutrition

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Gastric residual volume (GRV) was measured in one group and not in the other. Nutrition was started at an infusion rate of 20 ml/hour in the GRV group. The GRV was measured every four hours. When it was less than 200 ml, the infusion rate was increased by 20 ml/hour. The infusion rate, which was increased every four hours according to the GRV, was continued constantly when the target calorie was reached. It was kept constant when the GRV was above 200 ml, and then the feeding rate was reduced to half when the GRV volume was above 400 ml. In four patients, enteral nutrition was discontinued due to melena and excluded from the study. In six patients with persistently high GRV values, enteral nutrition was discontinued and parenteral nutrition initiated. The study was completed with 62 patients. GRV (n=31) and Non-GRV (n=31).
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Gastric residual volume group

Patients undergoing enteral nutrition with continuous infusion and intermittent gastric residual volume measurement in the intensive care unit

Group Type NO_INTERVENTION

No interventions assigned to this group

Non- Gastric residual volume group

Patients undergoing enteral nutrition with continuous infusion and intermittent gastric residual volume measurement was not measured in the intensive care unit

Group Type EXPERIMENTAL

Gastric residual volume measurement stopped.

Intervention Type OTHER

GRV is checked during routine enteral nutrition, but we think that GRV prolongs the time to reach target calories and does not reduce complications.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Gastric residual volume measurement stopped.

GRV is checked during routine enteral nutrition, but we think that GRV prolongs the time to reach target calories and does not reduce complications.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Mechanical ventilatory support
* open enteral route (nasogastric/PEG)

Exclusion Criteria

* History of gastrointestinal bleeding,
* parenteral nutrition support,
* hospital stay of fewer than two days,
* under 18 years of age
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Erzincan Binali Yildirim Universitesi

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Alparslan Koc

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Erzincan Binali Yildirim university

Erzincan, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

Marik PE. Enteral nutrition in the critically ill: myths and misconceptions. Crit Care Med. 2014 Apr;42(4):962-9. doi: 10.1097/CCM.0000000000000051.

Reference Type BACKGROUND
PMID: 24296860 (View on PubMed)

Elke G, Felbinger TW, Heyland DK. Gastric residual volume in critically ill patients: a dead marker or still alive? Nutr Clin Pract. 2015 Feb;30(1):59-71. doi: 10.1177/0884533614562841. Epub 2014 Dec 18.

Reference Type BACKGROUND
PMID: 25524884 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GRVROLE

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Refeeding Syndrome in Cancer Patients
NCT02534181 WITHDRAWN PHASE2
Diluted and Undiluted Enteral Nutrition
NCT06516835 NOT_YET_RECRUITING NA