Critically IllNCT04413474
Ultrasonographic Assessment of Gastric Residual Volume
An observational study of Critically Ill and Enteral Feeding Intolerance, run by Gurhan Taskin at 1 site in Turkey (Türkiye).
Trial summary
A recent systematic review reported that the prevalence of enteral nutrition intolerance in critically ill patients ranged from 2% to 75%, and the pooled rate was 38.3%.Many randomized controlled trials have reported that the incidence of pneumonia, regurgitation and aspiration do not correlate well with gastric… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Critically Ill, Enteral Feeding Intolerance
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 19 Jan 2019
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Mechanically ventilated critically ill patients receiving enteral feeding via nasogastric, orogastric, or percutaneous gastrostomy tubes who admitted to ICU in a one year period
Who may be able to join
- 18 years of age or older
- Mechanically ventilated in the intensive care unit
- Receiving enteral tube feeding via nasogastric, orogastric, or percutaneous gastrostomy tubes, and the tip of the enteral feeding-tube having been shown to be present in the stomach in a recent x-ray
Who cannot join
- Pregnancy
- Intestinal obstruction, gastric perforation, known upper gastrointestinal anatomical problem (e.g., hiatal hernia, gastric cancer, etc.)
- Food and liquid by mouth being withheld due to long-term fasting requirement for any medical reasons (e.g., gastrointestinal tract bleeding, etc.)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, Trabzon Kanuni Training and Research Hospital
Trabzon, 61250
About this study
Official title: Does Ultrasonographic Assessment of Gastric Antrum Correlate With Gastric Residual Volume in Critically Ill Patients? A Prospective Study
A recent systematic review reported that the prevalence of enteral nutrition intolerance in critically ill patients ranged from 2% to 75%, and the pooled rate was 38.3%.Many randomized controlled trials have reported that the incidence of pneumonia, regurgitation and aspiration do not correlate well with gastric residual volume (GRV) monitoring. In addition, it was reported that GRV monitoring may cause more frequent obstructions in the enteral tube access, leading to greater loss of time for intensive care unit nurses and patients receiving less than the prescribed daily intake due to enteral nutrition interruptions. The most recent SCCM/ASPEN guidelines in 2016 recommended that GRV monitoring not be included in the daily care protocol, but many institutions still use it to determine whether to continue enteral nutrition or to detect enteral tube-feeding intolerance. This study aimed to evaluate the relationship between ultrasonographic gastric antral measurements and aspirated gastric residual volume GRV in mechanically ventilated critically ill patients receiving enteral tube feeding via nasogastric, orogastric, or percutaneous gastrostomy tubes.
Read the detailed description
Data collection and measurements:
The following clinical parameters of included patients will be recorded: age, sex, body weight, height, body mass index, Acute Physiology and Chronic Health Evaluation II (APACHE II) score on the day of admission,the Charlson Comorbidity Index score, any comorbid diseases, the total amount of EN product during the last 24 hours before ultrasonographic assessment, vasopressor therapy during imaging, and the dose of the vasopressors.
Ultrasonographic gastric antrum imaging procedure:
Ultrasonographic gastric antrum imaging will be carried out by the same intensivist on each patient just before routine tube-feed aspiration. Gastric antrum images will be obtained with a 2.5-6 MHz curvilinear probe placed in the sagittal plane of the epigastric region. All imaging attempts will be carried out in a 30-degree head-elevation supine position as described previously. Reference points will be used to obtain images of the gastric antrum-left anterior lobe of the liver, head of pancreas and abdominal aorta.The anteroposterior and craniocaudal diameters of the gastric antrum will be measured three times for each ultrasonographic assessment. The mean value of the three will be recorded. The universally accepted Two-Diameter Method defined by Bolondi et al. will be used for the measurement of antral cross-sectional area.
Tube-feeding aspiration (GRV measurement) procedure:
Routine gastric residual volume aspirations will be performed by the nursing staff blinded to the ultrasonographic measurements. The time between gastric antrum imaging and the beginning of GRV aspiration will be recorded in minutes. Gastric contents will slowly aspirated with 50 ml syringes for at least 10 minutes until stomach contents could no longer be aspirated. Patients will be reassessed with ultrasonography after the aspiration to ensure that the stomach is completely emptied with aspiration.
- Conditions
- Critically Ill, Enteral Feeding Intolerance
- Keywords
- critical care, ultrasonography, enteral feeding, enteral nutrition, feeding intolerance, gastric 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.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Unselected critically ill patients who met the inclusion criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between antral cross-sectional area and enteral tube feeding volumes.
The correlation between aspirated tube-feeding volumes and ultrasonographic gastric antral cross-sectional area measurements in critically ill patients receiving enteral tube feeding.
Measured: From date of inclusion until the date of enteral tube-feeding termination or until the date of weaning from mechanical ventilation or until the date of discharging from ICU or until the date of the death, whichever came first, assessed up to one month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 Jan 2018
- Primary completion19 Jan 2019
- Study completion19 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically IllStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Gurhan Taskin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gurhan Taskin, Gulhane School of Medicine
- Investigators
- Gurhan Taskin, MD, Principal investigator, Gulhane School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04413474
- Sponsor's protocol ID
- 2017/72
- Status last verified
- Jun 2020
- First submitted
- 23 May 2020
- Last updated
- 17 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual patient data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Ultrasonographic Assessment of Gastric Antrum Correlate With Gastric Residual Volume in Critically Ill Patients? A Prospective Study
- ClinicalTrials.gov ID
- NCT04413474
- Acronym / sponsor ID
- 2017/72
- Conditions
- Critically Ill, Enteral Feeding Intolerance
- Keywords
- critical care, ultrasonography, enteral feeding, enteral nutrition, feeding intolerance, gastric volume
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Gurhan TaskinUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 19 Jan 2019 (actual)
- Study completion
- 19 Jan 2019 (actual)
- First posted
- 4 Jun 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.
A recent systematic review reported that the prevalence of enteral nutrition intolerance in critically ill patients ranged from 2% to 75%, and the pooled rate was 38.3%.Many randomized controlled trials have reported that the incidence of pneumonia, regurgitation and aspiration do not correlate well with gastric residual volume (GRV) monitoring. In addition, it was reported that GRV monitoring may cause more frequent obstructions in the enteral tube access, leading to greater loss of time for intensive care unit nurses and patients receiving less than the prescribed daily intake due to enteral nutrition interruptions. The most recent SCCM/ASPEN guidelines in 2016 recommended that GRV monitoring not be included in the daily care protocol, but many institutions still use it to determine whether to continue enteral nutrition or to detect enteral tube-feeding intolerance. This study aimed to evaluate the relationship between ultrasonographic gastric antral measurements and aspirated gastric residual volume GRV in mechanically ventilated critically ill patients receiving enteral tube feeding via nasogastric, orogastric, or percutaneous gastrostomy tubes.
Detailed description
Data collection and measurements:
The following clinical parameters of included patients will be recorded: age, sex, body weight, height, body mass index, Acute Physiology and Chronic Health Evaluation II (APACHE II) score on the day of admission,the Charlson Comorbidity Index score, any comorbid diseases, the total amount of EN product during the last 24 hours before ultrasonographic assessment, vasopressor therapy during imaging, and the dose of the vasopressors.
Ultrasonographic gastric antrum imaging procedure:
Ultrasonographic gastric antrum imaging will be carried out by the same intensivist on each patient just before routine tube-feed aspiration. Gastric antrum images will be obtained with a 2.5-6 MHz curvilinear probe placed in the sagittal plane of the epigastric region. All imaging attempts will be carried out in a 30-degree head-elevation supine position as described previously. Reference points will be used to obtain images of the gastric antrum-left anterior lobe of the liver, head of pancreas and abdominal aorta.The anteroposterior and craniocaudal diameters of the gastric antrum will be measured three times for each ultrasonographic assessment. The mean value of the three will be recorded. The universally accepted Two-Diameter Method defined by Bolondi et al. will be used for the measurement of antral cross-sectional area.
Tube-feeding aspiration (GRV measurement) procedure:
Routine gastric residual volume aspirations will be performed by the nursing staff blinded to the ultrasonographic measurements. The time between gastric antrum imaging and the beginning of GRV aspiration will be recorded in minutes. Gastric contents will slowly aspirated with 50 ml syringes for at least 10 minutes until stomach contents could no longer be aspirated. Patients will be reassessed with ultrasonography after the aspiration to ensure that the stomach is completely emptied with aspiration.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | –Unselected critically ill patients who met the inclusion criteria |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mechanically ventilated critically ill patients receiving enteral feeding via nasogastric, orogastric, or percutaneous gastrostomy tubes who admitted to ICU in a one year period
Key inclusion criteria (3 listed)
- 18 years of age or older
- Mechanically ventilated in the intensive care unit
- Receiving enteral tube feeding via nasogastric, orogastric, or percutaneous gastrostomy tubes, and the tip of the enteral feeding-tube having been shown to be present in the stomach in a recent x-ray
Key exclusion criteria (3 listed)
- Pregnancy
- Intestinal obstruction, gastric perforation, known upper gastrointestinal anatomical problem (e.g., hiatal hernia, gastric cancer, etc.)
- Food and liquid by mouth being withheld due to long-term fasting requirement for any medical reasons (e.g., gastrointestinal tract bleeding, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between antral cross-sectional area and enteral tube feeding volumes.
Time frame: From date of inclusion until the date of enteral tube-feeding termination or until the date of weaning from mechanical ventilation or until the date of discharging from ICU or until the date of the death, whichever came first, assessed up to one month.
The correlation between aspirated tube-feeding volumes and ultrasonographic gastric antral cross-sectional area measurements in critically ill patients receiving enteral tube feeding.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
- Individual participant dataSharing planned: Yes. All individual patient data that underlie results in a publication
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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.
Gurhan Taskin, MD principal investigator
Gulhane School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critically Ill and Enteral Feeding Intolerance, run by Gurhan Taskin at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 17 Jun 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between antral cross-sectional area and enteral tube feeding volumes. (time frame: From date of inclusion until the date of enteral tube-feeding termination or until the date of weaning from mechanical ventilation or until the date of discharging from ICU or until the date of the death, whichever came first, assessed up to one month.). 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 17 Jun 2020.