UltrasoundNCT04831593
The Rate of Full and Empty Stomach in Elective and Emergency Pediatric Patients
An observational study of Ultrasound and Children, run by Ankara Children's Health and Diseases Hematology and Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Background and Aim: Pulmonary aspiration of gastric content in the perioperative period is rare, but it is an important cause of morbidity and mortality that anesthetists never want to encounter. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Ultrasound, Children, Surgery
- What is being tested?
- Group El and Group Em
- How many people
- 600 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2021to 30 Oct 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 Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Pediatric patients younger than 18 yr old who are to undergo elective and emergency surgery under general anaesthesia
Who may be able to join
- Pediatric patients younger than 18 yr old who are to undergo elective and emergency surgery under general anaesthesia are included in the study.
Who cannot join
- Exclusion criteria will be, having a nasogastric tube inserted and patient refusal.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara City Hospital Childrens' Hospital
Ankara, Çankaya, 06800
About this study
Official title: The Rate of Full and Empty Stomach in a Large Cohort of Elective and Emergency Pediatric Patients by Preoperative Ultrasound Examination: a Prospective Observational Study
Background and Aim:
Pulmonary aspiration of gastric content in the perioperative period is rare, but it is an important cause of morbidity and mortality that anesthetists never want to encounter. Due to reasons such as emergency surgical procedures, communication problems with pediatric patients or their parents, impaired cognitive function, obesity, diabetes mellitus, chronic liver and kidney diseases, it is observed that there is sometimes inconsistency between the periods defined in the preoperative fasting guidelines in pediatric patients and the state of gastric content and volume encountered in clinical practice. There is a lack of data on children on this issue. In this study, primary we aimed to evaluate the incidence of empty and full stomach in pediatric patients who underwent elective and emergency surgery in our routine anesthesia practice. Also we want to determine the relationship between fasting time and qualitative assessment of gastric content. Secondary this study sought to examine whether correlation between gastric ultrasound finding and fasting time, and also to determine relationship with the current comorbidities.
Read more
Design:
This is a prospective, single blinded, observational study. The minimum sample size required to determine the prevalence of full stomach, 0.05, within the limits of ± 0.025 with 0.95 confidence, was calculated as 292.
When calculating with the proposed equation of n = 100 + 50i to determine the factors affecting by logistic regression (here i is the number of variables in the model), the minimum number of samples required for logistic regression analysis was calculated as 300 in case of 4 independent variables in the model. n=100+50*4= 300
Methods:
Pediatric patients younger than 18 yr old who are to undergo elective and emergency surgery under general anaesthesia at our hospital are enrolled in this prospective observational study between April and December 2021. Preoperative ultrasound examination of the gastric antrum are performed by one anesthesiologist who has been instructed and supervised by an experienced pediatric radiologist and who is blind to the patient's history. Ultrasonographic measurement of the gastric antral cross-sectional area (CSA) are performed in supine position and right lateral decubitus position (RLD). The gastric antrum is imaged in a sagittal plane, between the left lobe of the liver and the pancreas, at the level of the aorta, as previously described [1]. This examination allowed qualitative assessment of gastric contents according to the three-point grading scale previously described by Perlas and colleagues[2]. Grade 0 was defined by the absence of appearance of any content in a flat antrum in both the supine and the RLD positions. Grade 1 was defined by the appearance of any gastric content in the RLD position only, and Grade 2 was defined by the appearance of any content in both the RLD and the supine positions. The antral cross-sectional area is also calculated in both position, by measuring the longitudinal diameter (D1) and the anteroposterior diameter (D2) of the antrum, from serosa to serosa using this formula [3] Antral area= (π x D1 X D2) / 4. Patients' characteristic data ( age, gender, weight, height, BMI and ASA physical status classification), fasting duration, type of elective and emergency surgery, chronic disease and complications (regurgitation, pulmonary aspiration, etc.) that may develop during the peroperative period are recorded.
- Conditions
- Ultrasound, Children, Surgery
- Being tested
- Group El, Group Em
- Keywords
- Ultrasound, Antrum, Children, Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group ElOther
Also called Gastric ultrasound in elective pediatric patients before general anesthesia.
Gastric ultrasound is a point-of-care diagnostic tool to examine stomach contents and determine pulmonary aspiration risk at the bedside. Qualitative gastric sonography can determine the nature of gastric content ( empty, clear fluid or thick fluid/solid ) and quantitative gastric ultrasound can estimate the volume of gastric fluid.
Group EmOther
Also called Gastric ultrasound in emergency pediatric patients before general anesthesia.
Gastric ultrasound is a point-of-care diagnostic tool to examine stomach contents and determine pulmonary aspiration risk at the bedside. Qualitative gastric sonography can determine the nature of gastric content ( empty, clear fluid or thick fluid/solid ) and quantitative gastric ultrasound can estimate the volume of gastric fluid.
| Study group | Role | What they receive |
|---|---|---|
| Group Elective | In our clinic, pediatric patients who will undergo elective surgery, are performed gastric ultrasound before the operation. We aimed to see how often we met with empty and full stomach and to determine relationship between fasting time and qualitative assessment of gastric content in elective pediatric patients before general anesthesia. Receives: Other: Group El | |
| Group Emergency | In our clinic, pediatric patients who will undergo emergency surgery, are performed gastric ultrasound before the operation. We aimed to see how often we met with empty and full stomach and to determine relationship between fasting time and qualitative assessment of gastric content in emergency pediatric patients before general anesthesia. Receives: Other: Group Em |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of full stomach
In our clinic, pediatric patients who will undergo emergency and elective surgery, are performed gastric ultrasound before the operation. We aimed to see how often we met with empty and full stomach in pediatric patients before general anesthesia.
Measured: 30 minutes
The relationship between fasting time and qualitative assessment of gastric content
We would like to determine the relationship (and correlation with preoperative fasting guidelines) between the fasting time that pediatric patients and their parents reported to us and the qualitative assessment of gastric content in our clinical practice
Measured: 30 minutes
Secondary outcomes (1)
Demographic data and comorbidities
The secondary objective of this study is to examine correlation between gastric ultrasound finding and the demographic data ( age, gender, weight, height, BMI, ASA physical status classification), and type of elective and emergency surgery ) and current comorbidities of pediatric patients.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start1 Apr 2021
- Primary completion30 Oct 2022 (estimated)
- Study completion30 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasoundStudies 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Children's Health and Diseases Hematology and Oncology Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Feyza Sever, Ankara Children's Health and Diseases Hematology and Oncology Training and Research Hospital
- Investigators
- Feyza Sever, Principal investigator, Ankara City Hospital Childrens' Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04831593
- Sponsor's protocol ID
- 2019-167
- Status last verified
- Jul 2022
- First submitted
- 31 Mar 2021
- Last updated
- 21 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Rate of Full and Empty Stomach in a Large Cohort of Elective and Emergency Pediatric Patients by Preoperative Ultrasound Examination: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04831593
- Acronym / sponsor ID
- 2019-167
- Conditions
- Ultrasound, Children, Surgery
- Keywords
- Ultrasound, Antrum, Children, Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Ankara Children's Health and Diseases Hematology and Oncology Training and Research HospitalOther government
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Oct 2022 (estimated)
- Study completion
- 30 Oct 2022 (estimated)
- First posted
- 5 Apr 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.
Background and Aim:
Pulmonary aspiration of gastric content in the perioperative period is rare, but it is an important cause of morbidity and mortality that anesthetists never want to encounter. Due to reasons such as emergency surgical procedures, communication problems with pediatric patients or their parents, impaired cognitive function, obesity, diabetes mellitus, chronic liver and kidney diseases, it is observed that there is sometimes inconsistency between the periods defined in the preoperative fasting guidelines in pediatric patients and the state of gastric content and volume encountered in clinical practice. There is a lack of data on children on this issue. In this study, primary we aimed to evaluate the incidence of empty and full stomach in pediatric patients who underwent elective and emergency surgery in our routine anesthesia practice. Also we want to determine the relationship between fasting time and qualitative assessment of gastric content. Secondary this study sought to examine whether correlation between gastric ultrasound finding and fasting time, and also to determine relationship with the current comorbidities.
Design:
This is a prospective, single blinded, observational study. The minimum sample size required to determine the prevalence of full stomach, 0.05, within the limits of ± 0.025 with 0.95 confidence, was calculated as 292.
When calculating with the proposed equation of n = 100 + 50i to determine the factors affecting by logistic regression (here i is the number of variables in the model), the minimum number of samples required for logistic regression analysis was calculated as 300 in case of 4 independent variables in the model. n=100+50*4= 300
Methods:
Pediatric patients younger than 18 yr old who are to undergo elective and emergency surgery under general anaesthesia at our hospital are enrolled in this prospective observational study between April and December 2021. Preoperative ultrasound examination of the gastric antrum are performed by one anesthesiologist who has been instructed and supervised by an experienced pediatric radiologist and who is blind to the patient's history. Ultrasonographic measurement of the gastric antral cross-sectional area (CSA) are performed in supine position and right lateral decubitus position (RLD). The gastric antrum is imaged in a sagittal plane, between the left lobe of the liver and the pancreas, at the level of the aorta, as previously described [1]. This examination allowed qualitative assessment of gastric contents according to the three-point grading scale previously described by Perlas and colleagues[2]. Grade 0 was defined by the absence of appearance of any content in a flat antrum in both the supine and the RLD positions. Grade 1 was defined by the appearance of any gastric content in the RLD position only, and Grade 2 was defined by the appearance of any content in both the RLD and the supine positions. The antral cross-sectional area is also calculated in both position, by measuring the longitudinal diameter (D1) and the anteroposterior diameter (D2) of the antrum, from serosa to serosa using this formula [3] Antral area= (π x D1 X D2) / 4. Patients' characteristic data ( age, gender, weight, height, BMI and ASA physical status classification), fasting duration, type of elective and emergency surgery, chronic disease and complications (regurgitation, pulmonary aspiration, etc.) that may develop during the peroperative period are recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Elective | – | Other: Group ElIn our clinic, pediatric patients who will undergo elective surgery, are performed gastric ultrasound before the operation. We aimed to see how often we met with empty and full stomach and to determine relationship between fasting time and qualitative assessment of gastric content in elective pediatric patients before general anesthesia. |
| Group Emergency | – | Other: Group EmIn our clinic, pediatric patients who will undergo emergency surgery, are performed gastric ultrasound before the operation. We aimed to see how often we met with empty and full stomach and to determine relationship between fasting time and qualitative assessment of gastric content in emergency pediatric patients before general anesthesia. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients younger than 18 yr old who are to undergo elective and emergency surgery under general anaesthesia
Key inclusion criteria (1 listed)
- Pediatric patients younger than 18 yr old who are to undergo elective and emergency surgery under general anaesthesia are included in the study.
Key exclusion criteria (1 listed)
- Exclusion criteria will be, having a nasogastric tube inserted and patient refusal.
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 |
|---|---|---|
| Group ElAlso: Gastric ultrasound in elective pediatric patients before general anesthesia.Gastric ultrasound is a point-of-care diagnostic tool to examine stomach contents and determine pulmonary aspiration risk at the bedside. Qualitative gastric sonography can determine the nature of gastric content ( empty, clear fluid or thick fluid/solid ) and quantitative gastric ultrasound can estimate the volume of gastric fluid. | Other | Group Elective |
| Group EmAlso: Gastric ultrasound in emergency pediatric patients before general anesthesia.Gastric ultrasound is a point-of-care diagnostic tool to examine stomach contents and determine pulmonary aspiration risk at the bedside. Qualitative gastric sonography can determine the nature of gastric content ( empty, clear fluid or thick fluid/solid ) and quantitative gastric ultrasound can estimate the volume of gastric fluid. | Other | Group Emergency |
Primary outcome
Prevalence of full stomach
Time frame: 30 minutes
In our clinic, pediatric patients who will undergo emergency and elective surgery, are performed gastric ultrasound before the operation. We aimed to see how often we met with empty and full stomach in pediatric patients before general anesthesia.
The relationship between fasting time and qualitative assessment of gastric content
Time frame: 30 minutes
We would like to determine the relationship (and correlation with preoperative fasting guidelines) between the fasting time that pediatric patients and their parents reported to us and the qualitative assessment of gastric content in our clinical practice
1 secondary outcome
Demographic data and comorbidities
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
Related trials for Ultrasound
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
Active, not recruiting
Effects of Resistance Exercise on Enthesitis in Patients With Spondyloarthritis
Spondyloarthritis (SpA), Axial Spondylarthritis (axSpA)
Recruiting
Minimum Effective Local Anesthetic Volume for Ultrasound Guided Superior Trunk Block
Musculoskeletal Diseases or Conditions
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
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.
Feyza Sever principal investigator
Ankara City Hospital Childrens' 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 Ultrasound and Children, run by Ankara Children's Health and Diseases Hematology and Oncology Training and Research Hospital 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 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: status not confirmed, as of the sponsor's last update on 21 Jul 2022. 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?
Results are not available in the source record.
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?
Prevalence of full stomach (time frame: 30 minutes). The study lists 2 primary outcomes in all. 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 21 Jul 2022.