Gastric Residual VolumeCarborieNCT05106933
The Effect of Carbohydrate Loading 2 Hours Before Gastroscopy on Gastric Residual Volume and Patient's Well-being Score
A study testing Plain water and Carborie in people with Gastric Residual Volume and Upper Endoscopy, run by Hospital Universiti Sains Malaysia at 1 site in Malaysia.
Trial summary
This is a single-blind randomized controlled trial with a stratified (diabetes mellitus, non-diabetes mellitus), balanced randomization (1:1), placebo-controlled study regarding the effect of carbohydrate loading 2 hours prior to the outpatient upper endoscopic procedure. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastric Residual Volume, Upper Endoscopy
- What is being tested?
- Plain water and Carborie
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jan 2021to 20 Oct 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient 18 years old and above
- Agree to participate
Who cannot join
- History of upper gastrointestinal surgery
- Patient with active gastrointestinal bleeding
- Unstable clinical condition
- Mentally disable or who cannot give an informed consent
- Patient on the nasogastric feeding tube
- Pregnant patient
Show all 9Show fewer
- American Society of Anesthesiologists classification of physical status grade 3 or above
- Insulin dependent Diabetes Mellitus more than 10 years
- Patient who is carbohydrate intolerance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Carbohydrate Loading 2 Hours Before Upper Endoscopy on Gastric Residual Volume and Patient's Well-being Score : A Single-Blind, Randomized Controlled Trial Study
This is a single-blind randomized controlled trial with a stratified (diabetes mellitus, non-diabetes mellitus), balanced randomization (1:1), placebo-controlled study regarding the effect of carbohydrate loading 2 hours prior to the outpatient upper endoscopic procedure. All patients who were assigned for outpatient oesophagogastroduodenoscopy (OGDS) were invited to join in this study voluntarily from January 2021 until August 2021. This study was conducted in the Endoscopy Unit, Hospital Universiti Sains Malaysia, Kubang Kerian, Malaysia. The endoscopists that performed this procedure were blinded and there was trained staff who was not involved in the study to assess the well-being score. The study protocol had been approved by the Human Research Ethics Committee of Universiti Sains Malaysia (JEPeM) with the assigned protocol code USM/JEPeM/20080414.
Read the detailed description
Patient planned for OGDS in HUSM will be randomized into 2 groups. Plain water is given to group A of subject and carbohydrate loading is given to group B subject 2 hours before OGDS. Gastric residual volume is visualized directly and measured through aspiration via OGDS and subject's well-being is assessed for both group of the subject prior and after clear fluid have been given.
Methodology :
Research design :- This is a single-blind randomized controlled trial. This is a stratified (diabetes mellitus, non-diabetes mellitus) with balanced randomization (1:1), placebo-controlled study Study area :- This study will be conducted in the endoscopy room, Hospital Universiti Sains Malaysia (HUSM) in Kubang Kerian, Kelantan, Malaysia
All subjected planned for OGDS with the complaint of one or more of the following symptoms : Bothersome postprandial fullness, early satiety, epigastric pain or epigastric burning and fulfill the inclusion criteria are selected. Patients will be approached and be explained regarding the study in surgical outpatient clinic before OGDS. The patient will be approached again on the day of OGDS, if agree to participate, informed consent will be obtained. Informed consent will be obtained after explanation regarding the study and procedure again by researcher nurse.
The allocation sequence is according to computer-generated random number list, it was prepared by an investigator with no clinical involvement in the trial. The allocation sequence was concealed from researcher enrolling and assessing participants. The allocation sequence will be sealed in sequentially numbered and opaque envelopes. A manila card will be placed inside envelop to render it impermeable to intense light. To prevent subversion of the allocation sequence, the name and identification number of the participants will be written on a book together with the series number on the envelope. The details in the book will be kept confidentially.
After enrolled subject complete all the baseline assessment, the corresponding envelope will be enclosed by the trained staff (who not involved in the study) who prepare the drink. The staff need to ensure that the envelop is still sealed when receiving it. The staff will prepare the drink into an identical container according to the assignment.
The subjects are randomized into 2 groups: 1 group with 400mL plain water and another group given 1 packet carborie (400mL). Subjects need to finish the drink over 10 minutes. After that, subjects are not allowed to leave endoscope room until finish OGDS to prevent consumption of other drink or food.
2 hours after that, the subject undergoes OGDS. OGDS is performed following the standard protocol.
- The patient lies in the left lateral position
- Medication/lignocaine spray to numb the back of throats (spray) will be given to prevent gagging during the passage of the instrument
- A plastic mouth guard (mouthpiece) is placed between the teeth to prevent damage to the teeth and endoscope
- The endoscope (also called a gastroscope) will be inserted through the mouthpiece
- A small container or yankauer suction is placed close to the mouth of a patient to collect saliva during and after the oesophagogastroduodenoscopy (OGDS)
- The endoscope will be inserted along the middle line of the soft palate
- Once endoscope advanced, the patient may be asked to swallow to facilitate advancement of scope
- Throughout the procedure, no water flushing is allowed, only air inflation is allowed.
Visualized pooling of fluid in the stomach is aspirated until dry via direct visualization with the endoscope. The aspirated fluid will be collected in the suction reservoir and the fluid will be measured
Subject's well-being score is assessed via visual analogue scale (VAS) which consist of 5 parameters: hunger, thirst, anxiety, tiredness and general discomfort. This scale will be used repeatedly during this study to assess the patient's well-being. The trained staff nurse will ask the patient regarding the level of 5 parameters and subject need to mark [X] somewhere along the horizontal line given before drink and before OGDS procedure.
All subjects are advised to inform assessor if there is an adverse reaction. Medical personnel are available to manage any adverse events that might occur throughout the procedure.
The possible risk that may arise in the study includes injury to the gastrointestinal wall, aspiration and bleeding which is the similar risk for all patient undergoing for OGDS procedure. The small volume of the drink will not cause psychological distress to the subject, but its taste may not be palatable.
- Conditions
- Gastric Residual Volume, Upper Endoscopy
- Being tested
- Plain water, Carborie
- Keywords
- GRV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plain waterOther
Measure gastric residual volume during upper endoscopic, after given plain water and carborie 2 hours prior upper endoscopy
CarborieOther
carbohydrate drink
| Study group | Role | What they receive |
|---|---|---|
| Plain water | Placebo comparator | Group A patient will be given 400cc of plain water, 2 hours prior to gastroscopy Receives: Other: Plain water |
| Carborie | Experimental | Group B patient will be given 400cc of carborie (carbohydrate drink), 2 hours prior to gastroscopy Receives: Other: Carborie |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the gastric residual volume 2 hours after carbohydrate loading (intervention group) and plain water group (control group)
Patients will be randomised into control group and intervention group. Those in intervention group will have to drink clear water containing carbohydrate (carborie) 2 hours prior to gastroscopy. Endoscopist will measure patient's gastric residual volume. Residual gastric fluid will be aspirated into the container, final volume will be measured.
Measured: 2 hour before OGDS
Secondary outcomes (1)
To compare the patient's well-being after ingestion of carbohydrate loading (intervention group) and plain water (control group)
To assess patient well-being score before and after giving carborie load. Visual analogue scale (VAS) used for assessment of patient well-being. Just before and after the ingestion of the clear fluid patients are told to indicate the level of discomfort on a visual analogue scale which ranged from 0mm to 100mm. Zero signifying not at all while 100 signify the most imaginable/maximum discomfort.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start1 Jan 2021
- Primary completion31 Aug 2021
- Study completion20 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Carbohydrate loading vs Clear water
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MOHD FIRDAUS BIN ZULKIFLI, Hospital Universiti Sains Malaysia
- Investigators
- Nizam Hashim, Master, Study director, HUSM, Kubang Kerian, Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106933
- Sponsor's protocol ID
- HUSM Malaysia
- Acronym
- Carborie
- Status last verified
- Nov 2021
- First submitted
- 9 Oct 2021
- Last updated
- 12 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Qureshi WA, Zuckerman MJ, Adler DG, Davila RE, Egan JV, Gan SI, Lichtenstein DR, Rajan E, Shen B, Fanelli RD, Van Guilder T, Baron TH; Standards of Practice Committee, American Society for Gastrointestinal Endoscopy. ASGE guideline: modifications in endoscopic practice for the elderly. Gastrointest Endosc. 2006 Apr;63(4):566-9. doi: 10.1016/j.gie.2006.02.001. No abstract available.
PubMed 16564853De Silva AP, Amarasiri L, Liyanage MN, Kottachchi D, Dassanayake AS, de Silva HJ. One-hour fast for water and six-hour fast for solids prior to endoscopy provides good endoscopic vision and results in minimum patient discomfort. J Gastroenterol Hepatol. 2009 Jun;24(6):1095-7. doi: 10.1111/j.1440-1746.2009.05782.x. Epub 2009 Feb 12.
PubMed 19220672Sabry R, Hasanin A, Refaat S, Abdel Raouf S, Abdallah AS, Helmy N. Evaluation of gastric residual volume in fasting diabetic patients using gastric ultrasound. Acta Anaesthesiol Scand. 2019 May;63(5):615-619. doi: 10.1111/aas.13315. Epub 2019 Jan 4.
PubMed 30609007Spada C, McNamara D, Despott EJ, Adler S, Cash BD, Fernandez-Urien I, Ivekovic H, Keuchel M, McAlindon M, Saurin JC, Panter S, Bellisario C, Minozzi S, Senore C, Bennett C, Bretthauer M, Dinis-Ribeiro M, Domagk D, Hassan C, Kaminski MF, Rees CJ, Valori R, Bisschops R, Rutter MD. Performance measures for small-bowel endoscopy: A European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative. United European Gastroenterol J. 2019 Jun;7(5):614-641. doi: 10.1177/2050640619850365. Epub 2019 May 15.
PubMed 31210941American Society of Anesthesiologists Committee. Practice guidelines for preoperative fasting and the use of pharmacologic agents to reduce the risk of pulmonary aspiration: application to healthy patients undergoing elective procedures: an updated report by the American Society of Anesthesiologists Committee on Standards and Practice Parameters. Anesthesiology. 2011 Mar;114(3):495-511. doi: 10.1097/ALN.0b013e3181fcbfd9. No abstract available.
PubMed 21307770Zulkifli MF, Md Hashim MN, Zahari Z, Wong MP, Syed Abd Aziz SH, Yahya MM, Wan Zain WZ, Zakaria AD, Ramely R, Jien Yen S, Othman MF. The effect of pre-endoscopy maltodextrin beverage on gastric residual volume and patient's well-being: a randomised controlled trial. Sci Rep. 2023 Nov 16;13(1):20078. doi: 10.1038/s41598-023-47357-5.
PubMed 37973795
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Carbohydrate Loading 2 Hours Before Upper Endoscopy on Gastric Residual Volume and Patient's Well-being Score : A Single-Blind, Randomized Controlled Trial Study
- ClinicalTrials.gov ID
- NCT05106933
- Acronym / sponsor ID
- Carborie / HUSM Malaysia
- Conditions
- Gastric Residual Volume, Upper Endoscopy
- Keywords
- GRV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Hospital Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 20 Oct 2021 (actual)
- First posted
- 4 Nov 2021 (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 single-blind randomized controlled trial with a stratified (diabetes mellitus, non-diabetes mellitus), balanced randomization (1:1), placebo-controlled study regarding the effect of carbohydrate loading 2 hours prior to the outpatient upper endoscopic procedure. All patients who were assigned for outpatient oesophagogastroduodenoscopy (OGDS) were invited to join in this study voluntarily from January 2021 until August 2021. This study was conducted in the Endoscopy Unit, Hospital Universiti Sains Malaysia, Kubang Kerian, Malaysia. The endoscopists that performed this procedure were blinded and there was trained staff who was not involved in the study to assess the well-being score. The study protocol had been approved by the Human Research Ethics Committee of Universiti Sains Malaysia (JEPeM) with the assigned protocol code USM/JEPeM/20080414.
Detailed description
Patient planned for OGDS in HUSM will be randomized into 2 groups. Plain water is given to group A of subject and carbohydrate loading is given to group B subject 2 hours before OGDS. Gastric residual volume is visualized directly and measured through aspiration via OGDS and subject's well-being is assessed for both group of the subject prior and after clear fluid have been given.
Methodology :
Research design :- This is a single-blind randomized controlled trial. This is a stratified (diabetes mellitus, non-diabetes mellitus) with balanced randomization (1:1), placebo-controlled study Study area :- This study will be conducted in the endoscopy room, Hospital Universiti Sains Malaysia (HUSM) in Kubang Kerian, Kelantan, Malaysia
All subjected planned for OGDS with the complaint of one or more of the following symptoms : Bothersome postprandial fullness, early satiety, epigastric pain or epigastric burning and fulfill the inclusion criteria are selected. Patients will be approached and be explained regarding the study in surgical outpatient clinic before OGDS. The patient will be approached again on the day of OGDS, if agree to participate, informed consent will be obtained. Informed consent will be obtained after explanation regarding the study and procedure again by researcher nurse.
The allocation sequence is according to computer-generated random number list, it was prepared by an investigator with no clinical involvement in the trial. The allocation sequence was concealed from researcher enrolling and assessing participants. The allocation sequence will be sealed in sequentially numbered and opaque envelopes. A manila card will be placed inside envelop to render it impermeable to intense light. To prevent subversion of the allocation sequence, the name and identification number of the participants will be written on a book together with the series number on the envelope. The details in the book will be kept confidentially.
After enrolled subject complete all the baseline assessment, the corresponding envelope will be enclosed by the trained staff (who not involved in the study) who prepare the drink. The staff need to ensure that the envelop is still sealed when receiving it. The staff will prepare the drink into an identical container according to the assignment.
The subjects are randomized into 2 groups: 1 group with 400mL plain water and another group given 1 packet carborie (400mL). Subjects need to finish the drink over 10 minutes. After that, subjects are not allowed to leave endoscope room until finish OGDS to prevent consumption of other drink or food.
2 hours after that, the subject undergoes OGDS. OGDS is performed following the standard protocol.
- The patient lies in the left lateral position
- Medication/lignocaine spray to numb the back of throats (spray) will be given to prevent gagging during the passage of the instrument
- A plastic mouth guard (mouthpiece) is placed between the teeth to prevent damage to the teeth and endoscope
- The endoscope (also called a gastroscope) will be inserted through the mouthpiece
- A small container or yankauer suction is placed close to the mouth of a patient to collect saliva during and after the oesophagogastroduodenoscopy (OGDS)
- The endoscope will be inserted along the middle line of the soft palate
- Once endoscope advanced, the patient may be asked to swallow to facilitate advancement of scope
- Throughout the procedure, no water flushing is allowed, only air inflation is allowed.
Visualized pooling of fluid in the stomach is aspirated until dry via direct visualization with the endoscope. The aspirated fluid will be collected in the suction reservoir and the fluid will be measured
Subject's well-being score is assessed via visual analogue scale (VAS) which consist of 5 parameters: hunger, thirst, anxiety, tiredness and general discomfort. This scale will be used repeatedly during this study to assess the patient's well-being. The trained staff nurse will ask the patient regarding the level of 5 parameters and subject need to mark [X] somewhere along the horizontal line given before drink and before OGDS procedure.
All subjects are advised to inform assessor if there is an adverse reaction. Medical personnel are available to manage any adverse events that might occur throughout the procedure.
The possible risk that may arise in the study includes injury to the gastrointestinal wall, aspiration and bleeding which is the similar risk for all patient undergoing for OGDS procedure. The small volume of the drink will not cause psychological distress to the subject, but its taste may not be palatable.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Carbohydrate loading vs Clear water
| Arm | Type | Receives |
|---|---|---|
| Plain water | Placebo comparator | Other: Plain waterGroup A patient will be given 400cc of plain water, 2 hours prior to gastroscopy |
| Carborie | Experimental | Other: CarborieGroup B patient will be given 400cc of carborie (carbohydrate drink), 2 hours prior to gastroscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient 18 years old and above
- Agree to participate
Key exclusion criteria (9 listed)
- History of upper gastrointestinal surgery
- Patient with active gastrointestinal bleeding
- Unstable clinical condition
- Mentally disable or who cannot give an informed consent
- Patient on the nasogastric feeding tube
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 |
|---|---|---|
| Plain waterMeasure gastric residual volume during upper endoscopic, after given plain water and carborie 2 hours prior upper endoscopy | Other | Plain water |
| Carboriecarbohydrate drink | Other | Carborie |
Primary outcome
To compare the gastric residual volume 2 hours after carbohydrate loading (intervention group) and plain water group (control group)
Time frame: 2 hour before OGDS
Patients will be randomised into control group and intervention group. Those in intervention group will have to drink clear water containing carbohydrate (carborie) 2 hours prior to gastroscopy. Endoscopist will measure patient's gastric residual volume. Residual gastric fluid will be aspirated into the container, final volume will be measured.
1 secondary outcome
To compare the patient's well-being after ingestion of carbohydrate loading (intervention group) and plain water (control group)
Time frame: 2 hours
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 12 Nov 2021.
- Results publication: PubMed 16564853Qureshi WA, Zuckerman MJ, Adler DG, Davila RE, Egan JV, Gan SI, Lichtenstein DR, Rajan E, Shen B, Fanelli RD, Van Guilder T, Baron TH; Standards of Practice Committee, American Society for Gastrointestinal Endoscopy. ASGE guideline: modifications in endoscopic practice for the elderly. Gastrointest Endosc. 2006 Apr;63(4):566-9. doi: 10.1016/j.gie.2006.02.001. No abstract available.
- Results publication: PubMed 19220672De Silva AP, Amarasiri L, Liyanage MN, Kottachchi D, Dassanayake AS, de Silva HJ. One-hour fast for water and six-hour fast for solids prior to endoscopy provides good endoscopic vision and results in minimum patient discomfort. J Gastroenterol Hepatol. 2009 Jun;24(6):1095-7. doi: 10.1111/j.1440-1746.2009.05782.x. Epub 2009 Feb 12.
- Results publication: PubMed 30609007Sabry R, Hasanin A, Refaat S, Abdel Raouf S, Abdallah AS, Helmy N. Evaluation of gastric residual volume in fasting diabetic patients using gastric ultrasound. Acta Anaesthesiol Scand. 2019 May;63(5):615-619. doi: 10.1111/aas.13315. Epub 2019 Jan 4.
- Results publication: PubMed 31210941Spada C, McNamara D, Despott EJ, Adler S, Cash BD, Fernandez-Urien I, Ivekovic H, Keuchel M, McAlindon M, Saurin JC, Panter S, Bellisario C, Minozzi S, Senore C, Bennett C, Bretthauer M, Dinis-Ribeiro M, Domagk D, Hassan C, Kaminski MF, Rees CJ, Valori R, Bisschops R, Rutter MD. Performance measures for small-bowel endoscopy: A European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative. United European Gastroenterol J. 2019 Jun;7(5):614-641. doi: 10.1177/2050640619850365. Epub 2019 May 15.
- Results publication: PubMed 21307770American Society of Anesthesiologists Committee. Practice guidelines for preoperative fasting and the use of pharmacologic agents to reduce the risk of pulmonary aspiration: application to healthy patients undergoing elective procedures: an updated report by the American Society of Anesthesiologists Committee on Standards and Practice Parameters. Anesthesiology. 2011 Mar;114(3):495-511. doi: 10.1097/ALN.0b013e3181fcbfd9. No abstract available.
- Derived from this study: PubMed 37973795Zulkifli MF, Md Hashim MN, Zahari Z, Wong MP, Syed Abd Aziz SH, Yahya MM, Wan Zain WZ, Zakaria AD, Ramely R, Jien Yen S, Othman MF. The effect of pre-endoscopy maltodextrin beverage on gastric residual volume and patient's well-being: a randomised controlled trial. Sci Rep. 2023 Nov 16;13(1):20078. doi: 10.1038/s41598-023-47357-5.
- Individual participant dataSharing planned: No
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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.
Nizam Hashim, Master study director
HUSM, Kubang Kerian, Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plain water and Carborie in people with Gastric Residual Volume and Upper Endoscopy, run by Hospital Universiti Sains Malaysia at 1 site in Malaysia.
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 2 inclusion and 9 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 12 Nov 2021. 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 Malaysia. 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. Some participants in this study may receive a placebo. 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?
To compare the gastric residual volume 2 hours after carbohydrate loading (intervention group) and plain water group (control group) (time frame: 2 hour before OGDS). 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 NCT05106933, 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 12 Nov 2021.