Clinical CT Abdomen/Pelvic With Oral Contrast and SedationNCT02239068
CT Residual Gastric Fluid Volume
An observational study of Clinical CT Abdomen/Pelvic With Oral Contrast and Sedation, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
Hypothesis: The investigators hypothesize that more than 50% of the patients receiving enteric contrast material (ECM) < 2 hours of anesthesia/sedation would have residual gastric fluid volume (GFV) > 0.4 ml/kg. Read more about this study
- Who is it for?
- Ages 1 month to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Clinical CT Abdomen/Pelvic With Oral Contrast and Sedation
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2011to 1 Jun 2023
- 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 1 month to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Participants will be recruited from the Radiology CT schedule.
Who may be able to join
- Patients scheduled for CT abdomen with contrast and require anesthesia/sedation
- Subjects must be 1 month to 10 years of age (inclusive)
- The subject's legally authorized representative has given written informed consent to participate in the study
Who cannot join
- Subjects violate the institution fasting guideline before anesthesia /sedation with the exception of the oral contrast
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Residual Gastric Fluid With Administering Clear Liquids Within Two Hours of Anesthesia in Children
Hypothesis: The investigators hypothesize that more than 50% of the patients receiving enteric contrast material (ECM) < 2 hours of anesthesia/sedation would have residual gastric fluid volume (GFV) > 0.4 ml/kg. The investigators also hypothesize that measuring GFV by using region of interest in the CT technique is accurate compared to blind aspiration of the gastric contents with a syringe and a multi-orificed orogastric tube.
Read the detailed description
The purpose of our study is to examine the residual gastric fluid volume when oral contrast is administered within 2 hours of anesthesia /sedation and to validate the accuracy of measuring the residual gastric volume by using region of interest in the CT image by using blind aspiration of the gastric contents with a syringe and a multi-orificed orogastric tube.
- Keywords
- CT, sedation, oral contrast
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual gastric fluid volume (GFV) < 0.4ml/kg or > 0.4 ml/kg
Patients will have gastric volume suctioned and measured after the CT scan. The investigator will compare the amount suctioned to the measurement from the actual CT scan when all patients have been enrolled in the study.
Measured: Approximately 2 hours
Secondary outcomes (1)
Residual gastric fluid volume (GFV) < 0.8 ml/kg or > 0.8 ml/kg
Patients will have gastric volume suctioned and measured after the CT scan. The investigator will compare the amount suctioned to the measurement from the actual CT scan when all patients have been enrolled in the study.
Measured: Approximate 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study start28 Jun 2011
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical CT Abdomen/Pelvic With Oral Contrast and SedationStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed Mahmoud, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02239068
- Sponsor's protocol ID
- 2011-0286
- Status last verified
- Jan 2024
- First submitted
- 22 Jul 2014
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Residual Gastric Fluid With Administering Clear Liquids Within Two Hours of Anesthesia in Children
- ClinicalTrials.gov ID
- NCT02239068
- Acronym / sponsor ID
- 2011-0286
- Keywords
- CT, sedation, oral contrast
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 28 Jun 2011 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 12 Sep 2014 (estimated)
- 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.
Hypothesis: The investigators hypothesize that more than 50% of the patients receiving enteric contrast material (ECM) < 2 hours of anesthesia/sedation would have residual gastric fluid volume (GFV) > 0.4 ml/kg. The investigators also hypothesize that measuring GFV by using region of interest in the CT technique is accurate compared to blind aspiration of the gastric contents with a syringe and a multi-orificed orogastric tube.
Detailed description
The purpose of our study is to examine the residual gastric fluid volume when oral contrast is administered within 2 hours of anesthesia /sedation and to validate the accuracy of measuring the residual gastric volume by using region of interest in the CT image by using blind aspiration of the gastric contents with a syringe and a multi-orificed orogastric tube.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Participants will be recruited from the Radiology CT schedule.
Key inclusion criteria (3 listed)
- Patients scheduled for CT abdomen with contrast and require anesthesia/sedation
- Subjects must be 1 month to 10 years of age (inclusive)
- The subject's legally authorized representative has given written informed consent to participate in the study
Key exclusion criteria (1 listed)
- Subjects violate the institution fasting guideline before anesthesia /sedation with the exception of the oral contrast
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
Residual gastric fluid volume (GFV) < 0.4ml/kg or > 0.4 ml/kg
Time frame: Approximately 2 hours
Patients will have gastric volume suctioned and measured after the CT scan. The investigator will compare the amount suctioned to the measurement from the actual CT scan when all patients have been enrolled in the study.
1 secondary outcome
Residual gastric fluid volume (GFV) < 0.8 ml/kg or > 0.8 ml/kg
Time frame: Approximate 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 18 Jan 2024.
- Individual participant dataSharing planned: No
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.
Mohamed Mahmoud, MD principal investigator
Children's Hospital Medical Center, Cincinnati
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 Clinical CT Abdomen/Pelvic With Oral Contrast and Sedation, run by Children's Hospital Medical Center, Cincinnati 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 3 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 Jan 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 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?
Residual gastric fluid volume (GFV) < 0.4ml/kg or > 0.4 ml/kg (time frame: Approximately 2 hours). 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 Jan 2024.