Gastric Residual VolumeNCT06700759
Ultrasound Vs. Free Drainage for Gastric Volume in ICU Patients on Enteral Nutrition
An observational study of Gastric Residual Volume, run by Ilkay Ceylan at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the compatibility of gastric volume (GV) measurements obtained through ultrasound with the free drainage method in intensive care patients receiving enteral nutrition under three different protocols. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Residual Volume
- Type of treatment
- Injection or infusion
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2022to 1 Jul 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: neurocritical care patients
Who may be able to join
- Age Range: Adult patients aged 18 years and older.
- ICU Admission: The study will include only patients who are currently admitted to the Intensive Care Unit (ICU) due to cerebrovascular diseases
- Receiving Enteral Nutrition: Patients must be receiving enteral nutrition through one of the three specified protocols.
- Eligibility for Gastric Volume (GV) Measurement: Patients must be medically eligible for GV measurement via ultrasound.
- Informed Consent: The patient or their legal representative must provide informed consent to participate in the study.
Who cannot join
- Age Below 18: Patients under 18 years of age.
- Pregnancy: Pregnant patients will be excluded due to potential risks or confounding factors related to pregnancy.
- Gastrointestinal Surgery History: Patients with a recent history of gastrointestinal surgery, which may affect GV measurements, will be excluded.
- Contraindications for Ultrasound: Patients with conditions that prevent safe or accurate ultrasound measurement (e.g., severe abdominal wounds or high abdominal obesity) will be excluded.
- Inability to Tolerate Enteral Nutrition: Patients who are unable to receive enteral nutrition for any reason (e.g., severe intolerance, contraindications) will be excluded.
- Lack of Informed Consent: Patients or their legal representatives who do not provide informed consent.
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Yüksek İhtisas Education and Research Hospital
Bursa
About this study
Official title: Yoğun Bakım Ünitesinde Takip Edilen Hastalarda Gastrik Boşalmanın Abdominal Ultrasonografi Ile Değerlendirilmesi
This study aims to evaluate the compatibility of gastric volume (GV) measurements obtained through ultrasound with the free drainage method in intensive care patients receiving enteral nutrition under three different protocols. The study seeks to determine the consistency of GV measurements across these protocols to improve patient management in critical care settings.
Read the detailed description
Adult patients hospitalized in intensive care unit due to cerebrovascular disease and receiving mechanical ventilator treatment were included in the study. Patients who were started on semi-solid nutritional solution (standard nutritional products of 1kcal/1 ml according to the comorbidities of the patients) via nasogastric (NG) 14 F polyurethane (PU) feeding catheter (BAXEN Medical, Spain) and reached the full calorie goal for at least 24 hours were included. Full dose calorie calculation of the patients was performed using the Harris-Benedict method (for women: 655.1+(9.56xweight (kg)) -(1.85xheight (cm)) -(4.68xage) for men: 66.5+(13.75xweight (kg)) +(5.03xheight (cm)) -(6.75xage). Feeding tube placement was confirmed with an AP radiograph taken before inclusion in the study.
Patients with shock due to any cause, abdominal surgery, GI bleeding, obstruction, suspected perforation, malabsorption syndrome, prokinetic use or diarrhea, patients with a BMI >35 according to last known height and weight, and pregnant patients (due to inability to achieve right lateral position) were excluded. In addition, patients who could not be imaged, whose feeding protocol was changed and whose vasopressor doses were increased were excluded from the study.
The amount of EN products administered to the patients, age, gender, body weight, height, body mass index (BMI), comorbidities, vasopressor therapy and dose administered during imaging were recorded.
ICU units have a physician-driven nutrition strategy, aiming for an adequate caloric and protein intake. Patients were divided into 3 groups according to implemented nutrition protocols. Ultrasonographic measurements were performed in 24-hour periods after the volume required for the target calorie intake.
Group 1: Patients who received 18 hours of infusion feeding, 6 hours of waiting and one hour of drainage Group 2: Patients who received 5 hours of infusion feeding, 1 hour of waiting and one hour of drainage Group 3: Patients who were fed with continuous infusion for 24 hours and drained for one hour Measurement of gastric volume
- Measurement by GUSG Using the GE LOQIC P6 (GE healthcare, USA) ultrasound device available in clinic and a convex probe (2-5 MHz), the patient was placed in the right lateral position. To visualize the antrum, the probe was scanned in the sagittal plane in the epigastrium, sliding from left to right along the subcostal margins. The gastric antrum, aorta, superior mesenteric artery and inferior vena cava were visualized just below the left lobe of the liver with the pancreas posterior to it. For the calculation of cross-sectional antral area (CSA), the anterior-posterior diameter and cephalo-caudal diameter (measured 3 times and averaged) were measured from serosa to serosa by capturing the best image during peristaltic movements at the level of the aorta or inferior vena cava. The antral area was calculated according to the formula CSA=(AP×CC×π)/4 (π=3.14) developed by Bolondi et al. Two different formulas were then used to calculate GV by CSA. The first formula was proposed by Perlas et al.: Gastric volume (ml)=27+(14.6×right-lateral CSA)-1.28×age1. The second formula was developed by Tacken et al.: Gastric volume (ml)= 79.38+13.32 x right-lat CSA.
- Measurement by drainage After gastric volume was evaluated by USG, the patient was placed in supine position, NG was connected to a drainage bag and gravity/free drainage was performed in all groups for one hour and the GRV values were recorded.
- Conditions
- Gastric Residual Volume
- Keywords
- ultrasonography, gastric residual volume, enteral feeding
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 |
|---|---|---|
| Group 1 | Patients who received 18 hours of infusion feeding, 6 hours of waiting and one hour of drainage | |
| Group 2 | Patients who received 5 hours of infusion feeding, 1 hour of waiting and one hour of drainage | |
| Group 3 | Patients who were fed with continuous infusion for 24 hours and drained for one hour |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement Between Ultrasound and Free Drainage for Gastric Volume Measurements
Gastric volume will be measured in ICU patients using ultrasound imaging and the free drainage method. Agreement between the two methods will be evaluated using Bland-Altman analysis and Intraclass Correlation Coefficients (ICCs). The data will be reported as mean ± standard deviation for continuous variables and proportions for categorical data. Results will be aggregated across the three enteral nutrition protocols.
Measured: Gastric volume measurements will be conducted at 24 hours after initiating each enteral nutrition protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start20 Jan 2022
- Primary completion20 Jun 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Residual VolumeStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ilkay Ceylan
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Ilkay Ceylan, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- İlkay Ceylan, Principal investigator, Bursa Yüksek İhtisas Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700759
- Sponsor's protocol ID
- 2011-KAEK-25 2022/01-19
- Status last verified
- Nov 2024
- First submitted
- 13 Nov 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data collected throughout the trial.
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoğun Bakım Ünitesinde Takip Edilen Hastalarda Gastrik Boşalmanın Abdominal Ultrasonografi Ile Değerlendirilmesi
- ClinicalTrials.gov ID
- NCT06700759
- Acronym / sponsor ID
- 2011-KAEK-25 2022/01-19
- Conditions
- Gastric Residual Volume
- Keywords
- ultrasonography, gastric residual volume, enteral feeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Ilkay CeylanOther government
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 20 Jun 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 22 Nov 2024 (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 study aims to evaluate the compatibility of gastric volume (GV) measurements obtained through ultrasound with the free drainage method in intensive care patients receiving enteral nutrition under three different protocols. The study seeks to determine the consistency of GV measurements across these protocols to improve patient management in critical care settings.
Detailed description
Adult patients hospitalized in intensive care unit due to cerebrovascular disease and receiving mechanical ventilator treatment were included in the study. Patients who were started on semi-solid nutritional solution (standard nutritional products of 1kcal/1 ml according to the comorbidities of the patients) via nasogastric (NG) 14 F polyurethane (PU) feeding catheter (BAXEN Medical, Spain) and reached the full calorie goal for at least 24 hours were included. Full dose calorie calculation of the patients was performed using the Harris-Benedict method (for women: 655.1+(9.56xweight (kg)) -(1.85xheight (cm)) -(4.68xage) for men: 66.5+(13.75xweight (kg)) +(5.03xheight (cm)) -(6.75xage). Feeding tube placement was confirmed with an AP radiograph taken before inclusion in the study.
Patients with shock due to any cause, abdominal surgery, GI bleeding, obstruction, suspected perforation, malabsorption syndrome, prokinetic use or diarrhea, patients with a BMI >35 according to last known height and weight, and pregnant patients (due to inability to achieve right lateral position) were excluded. In addition, patients who could not be imaged, whose feeding protocol was changed and whose vasopressor doses were increased were excluded from the study.
The amount of EN products administered to the patients, age, gender, body weight, height, body mass index (BMI), comorbidities, vasopressor therapy and dose administered during imaging were recorded.
ICU units have a physician-driven nutrition strategy, aiming for an adequate caloric and protein intake. Patients were divided into 3 groups according to implemented nutrition protocols. Ultrasonographic measurements were performed in 24-hour periods after the volume required for the target calorie intake.
Group 1: Patients who received 18 hours of infusion feeding, 6 hours of waiting and one hour of drainage Group 2: Patients who received 5 hours of infusion feeding, 1 hour of waiting and one hour of drainage Group 3: Patients who were fed with continuous infusion for 24 hours and drained for one hour Measurement of gastric volume
- Measurement by GUSG Using the GE LOQIC P6 (GE healthcare, USA) ultrasound device available in clinic and a convex probe (2-5 MHz), the patient was placed in the right lateral position. To visualize the antrum, the probe was scanned in the sagittal plane in the epigastrium, sliding from left to right along the subcostal margins. The gastric antrum, aorta, superior mesenteric artery and inferior vena cava were visualized just below the left lobe of the liver with the pancreas posterior to it. For the calculation of cross-sectional antral area (CSA), the anterior-posterior diameter and cephalo-caudal diameter (measured 3 times and averaged) were measured from serosa to serosa by capturing the best image during peristaltic movements at the level of the aorta or inferior vena cava. The antral area was calculated according to the formula CSA=(AP×CC×π)/4 (π=3.14) developed by Bolondi et al. Two different formulas were then used to calculate GV by CSA. The first formula was proposed by Perlas et al.: Gastric volume (ml)=27+(14.6×right-lateral CSA)-1.28×age1. The second formula was developed by Tacken et al.: Gastric volume (ml)= 79.38+13.32 x right-lat CSA.
- Measurement by drainage After gastric volume was evaluated by USG, the patient was placed in supine position, NG was connected to a drainage bag and gravity/free drainage was performed in all groups for one hour and the GRV values were recorded.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Patients who received 18 hours of infusion feeding, 6 hours of waiting and one hour of drainage |
| Group 2 | – | –Patients who received 5 hours of infusion feeding, 1 hour of waiting and one hour of drainage |
| Group 3 | – | –Patients who were fed with continuous infusion for 24 hours and drained for one hour |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- neurocritical care patients
Key inclusion criteria (5 listed)
- Age Range: Adult patients aged 18 years and older.
- ICU Admission: The study will include only patients who are currently admitted to the Intensive Care Unit (ICU) due to cerebrovascular diseases
- Receiving Enteral Nutrition: Patients must be receiving enteral nutrition through one of the three specified protocols.
- Eligibility for Gastric Volume (GV) Measurement: Patients must be medically eligible for GV measurement via ultrasound.
- Informed Consent: The patient or their legal representative must provide informed consent to participate in the study.
Key exclusion criteria (7 listed)
- Age Below 18: Patients under 18 years of age.
- Pregnancy: Pregnant patients will be excluded due to potential risks or confounding factors related to pregnancy.
- Gastrointestinal Surgery History: Patients with a recent history of gastrointestinal surgery, which may affect GV measurements, will be excluded.
- Contraindications for Ultrasound: Patients with conditions that prevent safe or accurate ultrasound measurement (e.g., severe abdominal wounds or high abdominal obesity) will be excluded.
- Inability to Tolerate Enteral Nutrition: Patients who are unable to receive enteral nutrition for any reason (e.g., severe intolerance, contraindications) will be excluded.
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
Agreement Between Ultrasound and Free Drainage for Gastric Volume Measurements
Time frame: Gastric volume measurements will be conducted at 24 hours after initiating each enteral nutrition protocol
Gastric volume will be measured in ICU patients using ultrasound imaging and the free drainage method. Agreement between the two methods will be evaluated using Bland-Altman analysis and Intraclass Correlation Coefficients (ICCs). The data will be reported as mean ± standard deviation for continuous variables and proportions for categorical data. Results will be aggregated across the three enteral nutrition protocols.
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 22 Nov 2024.
- Individual participant dataSharing planned: Yes. All data collected throughout the trial.
Related trials for Gastric Residual Volume
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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.
İlkay Ceylan principal investigator
Bursa Yüksek İhtisas Training Hospital
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 Gastric Residual Volume, run by Ilkay Ceylan 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 5 inclusion and 7 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 22 Nov 2024. 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?
Agreement Between Ultrasound and Free Drainage for Gastric Volume Measurements (time frame: Gastric volume measurements will be conducted at 24 hours after initiating each enteral nutrition protocol). 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 22 Nov 2024.