Preoperative PeriodNCT04146233
POCUS Analysis of the Gastric Emptying Time of Orange Juice With and Without Pulp
A study testing Point of care gastric ultrasound in people with Preoperative Period and Anesthesia, run by Thomas Jefferson University at 1 site in United States.
Trial summary
Preoperative fasting guidelines for anesthesia recommend waiting two hours after ingesting a clear liquid and six hours after ingesting a light meal. Due to the presence of pulp, orange juice is considered a light meal by current guidelines which means a patient must wait six hours before undergoing general… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Preoperative Period, Anesthesia
- What is being tested?
- Point of care gastric ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2019to 17 Dec 2019
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- volunteers age 18-65 years old, American Society of Anesthesiologists physical status 1-2
Who cannot join
- presence of diabetes mellitus, previous gastric surgery, presence of hiatal hernia, history of delayed gastric emptying, pregnant patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: An Observer Blinded Point-of-care Gastric Ultrasound Analysis of the Gastric Emptying Time of Orange Juice With and Without Pulp
Preoperative fasting guidelines for anesthesia recommend waiting two hours after ingesting a clear liquid and six hours after ingesting a light meal. Due to the presence of pulp, orange juice is considered a light meal by current guidelines which means a patient must wait six hours before undergoing general anesthesia. This study will use ultrasound of stomach of healthy volunteers to determine if the presence of pulp actually increases the transit time for orange juice.
Read the detailed description
Healthy volunteers will be solicited (medical students and attending anesthesiologists) to participate in the study. Volunteers will participate in two sessions, one for orange juice without pulp and one for orange juice with pulp. Participants will be NPO after midnight and will be asked to arrive at approximately 8 am. Upon arrival for females of child bearing age, a urine pregnancy test will be performed and they will be discreetly informed of the results of the test. After, all patients will have their gastric volume assessed using point-of-care ultrasound to ensure the study team is able to adequately identify their stomach as well as to ensure the stomach is empty. After measurements are made, participants will drink 12 oz (approximately 350 mL) of either orange juice with or without pulp. Two hours after finishing the juice they will again undergo point-of-care gastric ultrasound scanning. Images will be saved and will be examined by a blinded independent anesthesiologist. The study will entail two visits each lasting for approximately 3 hours.
Point-of-care gastric ultrasound will be performed using a low-frequency curvilinear ultrasound probe. The exam will be performed on a stretcher with the participant in both the supine and right lateral decubitus (RLD) position. The goal of point-of-care gastric ultrasound is to obtain an image of the gastric antrum. The low-frequency large curvilinear probe is placed in the epigastric area in a sagittal or parasagittal plane immediately inferior to the patient's xiphisternum with the orientation marker directed cephalad. Image optimization requires scanning in an anterior and cephalad direction toward the liver by tilting the tail of the probe toward the feet. A qualitative analysis will occur first to rule out solid contents in the stomach. Once confirmed, the gastric antral cross-sectional area (CSA) will be measured in the RLD position. Correlation has been shown between CSA and total gastric fluid volume. A gastric volume less than 1.5 mL/kg is considered consistent with fasting.
The study will be repeated for both orange juice with and without pulp.
- Conditions
- Preoperative Period, Anesthesia
- Being tested
- Point of care gastric ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point of care gastric ultrasoundOther
Point-of-care gastric ultrasound will be performed using a low-frequency curvilinear ultrasound probe to assess stomach contents (empty vs. not empty, liquid vs. solid, gastric volume).
| Study group | Role | What they receive |
|---|---|---|
| Orange Juice without pulp | Other | Drink orange juice without pulp and have gastric ultrasound performed 2 hours later Receives: Other: Point of care gastric ultrasound |
| Orange juice with pulp | Other | Drink orange juice with pulp and have gastric ultrasound performed 2 hours later Receives: Other: Point of care gastric ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Gastric Volume at 2 hours
Two hours after orange juice (with and without pulp) is consumed, point of care gastric ultrasound will be used to assess gastric contents and gastric volume
Measured: 2 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start19 Nov 2019
- Primary completion17 Dec 2019
- Study completion17 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative PeriodStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Wahal, Thomas Jefferson University
- Investigators
- Christopher Wahal, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04146233
- Sponsor's protocol ID
- 19D.577
- Status last verified
- Mar 2020
- First submitted
- 29 Oct 2019
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observer Blinded Point-of-care Gastric Ultrasound Analysis of the Gastric Emptying Time of Orange Juice With and Without Pulp
- ClinicalTrials.gov ID
- NCT04146233
- Acronym / sponsor ID
- 19D.577
- Conditions
- Preoperative Period, Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 19 Nov 2019 (actual)
- Primary completion
- 17 Dec 2019 (actual)
- Study completion
- 17 Dec 2019 (actual)
- First posted
- 31 Oct 2019 (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.
Preoperative fasting guidelines for anesthesia recommend waiting two hours after ingesting a clear liquid and six hours after ingesting a light meal. Due to the presence of pulp, orange juice is considered a light meal by current guidelines which means a patient must wait six hours before undergoing general anesthesia. This study will use ultrasound of stomach of healthy volunteers to determine if the presence of pulp actually increases the transit time for orange juice.
Detailed description
Healthy volunteers will be solicited (medical students and attending anesthesiologists) to participate in the study. Volunteers will participate in two sessions, one for orange juice without pulp and one for orange juice with pulp. Participants will be NPO after midnight and will be asked to arrive at approximately 8 am. Upon arrival for females of child bearing age, a urine pregnancy test will be performed and they will be discreetly informed of the results of the test. After, all patients will have their gastric volume assessed using point-of-care ultrasound to ensure the study team is able to adequately identify their stomach as well as to ensure the stomach is empty. After measurements are made, participants will drink 12 oz (approximately 350 mL) of either orange juice with or without pulp. Two hours after finishing the juice they will again undergo point-of-care gastric ultrasound scanning. Images will be saved and will be examined by a blinded independent anesthesiologist. The study will entail two visits each lasting for approximately 3 hours.
Point-of-care gastric ultrasound will be performed using a low-frequency curvilinear ultrasound probe. The exam will be performed on a stretcher with the participant in both the supine and right lateral decubitus (RLD) position. The goal of point-of-care gastric ultrasound is to obtain an image of the gastric antrum. The low-frequency large curvilinear probe is placed in the epigastric area in a sagittal or parasagittal plane immediately inferior to the patient's xiphisternum with the orientation marker directed cephalad. Image optimization requires scanning in an anterior and cephalad direction toward the liver by tilting the tail of the probe toward the feet. A qualitative analysis will occur first to rule out solid contents in the stomach. Once confirmed, the gastric antral cross-sectional area (CSA) will be measured in the RLD position. Correlation has been shown between CSA and total gastric fluid volume. A gastric volume less than 1.5 mL/kg is considered consistent with fasting.
The study will be repeated for both orange juice with and without pulp.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orange Juice without pulp | Other | Other: Point of care gastric ultrasoundDrink orange juice without pulp and have gastric ultrasound performed 2 hours later |
| Orange juice with pulp | Other | Other: Point of care gastric ultrasoundDrink orange juice with pulp and have gastric ultrasound performed 2 hours later |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- volunteers age 18-65 years old, American Society of Anesthesiologists physical status 1-2
Key exclusion criteria (1 listed)
- presence of diabetes mellitus, previous gastric surgery, presence of hiatal hernia, history of delayed gastric emptying, pregnant patients
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 |
|---|---|---|
| Point of care gastric ultrasoundPoint-of-care gastric ultrasound will be performed using a low-frequency curvilinear ultrasound probe to assess stomach contents (empty vs. not empty, liquid vs. solid, gastric volume). | Other | Orange Juice without pulp, Orange juice with pulp |
Primary outcome
Assessment of Gastric Volume at 2 hours
Time frame: 2 hours after intervention
Two hours after orange juice (with and without pulp) is consumed, point of care gastric ultrasound will be used to assess gastric contents and gastric volume
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 18 Mar 2020.
- 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.
Christopher Wahal, MD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Point of care gastric ultrasound in people with Preoperative Period and Anesthesia, run by Thomas Jefferson University at 1 site in United States.
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 1 inclusion and 1 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 18 Mar 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 United States. 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?
Assessment of Gastric Volume at 2 hours (time frame: 2 hours after intervention). 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 18 Mar 2020.