Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001303730
Ethics application status
Approved
Date submitted
20/08/2022
Date registered
7/10/2022
Date last updated
7/10/2022
Date data sharing statement initially provided
7/10/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Preoperative ultrasound evaluation of gastric contents in children one hour after ingestion of clear liquid.
Scientific title
Preoperative ultrasound evaluation of gastric contents in children one hour after ingestion of clear liquid: Observational study.
Secondary ID [1] 307816 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
gastric emptying in children 327408 0
preoperative fasting time in children 327409 0
Condition category
Condition code
Anaesthesiology 324538 324538 0 0
Other anaesthesiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
All patients were scheduled 2 hours before the surgical procedure. The patients were questioned about the exclusion criteria. Data on gender, age and weight were collected from the clinical history by the anesthesiologist and recorded in the data collection instrument. 1 hour before the assigned time for surgery, they were asked to consume 3 mL/kg of body weight of a non-carbonated sports drink (140 calories, Total fat 0%, Sodium 11%, potassium 2%, carbohydrates 12%, protein 0%). Drink ingestion was supervised by a nurse and consumed in less than 5 minutes. All patients were instructed to adhere to the preoperative fasting guidelines of the American Society of Anesthesiology (6 hours for solid foods, 4 hours for breast milk, and 2 hours for clear liquids). 1 hour after ingestion of the drink, measurements of gastric contents were obtained by ultrasound before anesthetic induction. All patients had perioperative follow-up until discharge
Intervention code [1] 324284 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332362 0
Qualitative evaluation of gastric content after ingestion of 3 mL/kg of a non-carb sports drink.
The evaluation was performed with a Sonoscape model E2 Pro ultrasound machine using the 4 MHz convex transducer in patients weighing more than 40 kg and in those weighing less, the 11 MHz linear transducer. in the supine position (DS) and later, in right lateral decubitus (DLD), locating the gastric antrum in a sagittal plane between the left lobe of the liver and the pancreas at the level of the aorta. An empty stomach was defined as one with Grade 0 regardless of gastric volume, or Grade 1 with a gastric volume less than or equal to 1.5 mL/kg. Any Grade 2 qualitative assessment or gastric volume >1.5 mL/kg was considered a full stomach.
Timepoint [1] 332362 0
1 hour after ingestion of 3 mL/kg of non-carb sports drink
Primary outcome [2] 332545 0
Quantitative evaluation of gastric content 1 hour after ingestion of 3 mL/kg of a non-carbonated sports drink. The evaluation was performed with a Sonoscape model E2 Pro ultrasound machine using the 4 MHz convex transducer in patients weighing more than 40 kg and in those weighing less, the 11 MHz linear transducer. in the supine position (DS) and later, in right lateral decubitus (DLD), locating the gastric antrum in a sagittal plane between the left lobe of the liver and the pancreas at the level of the aorta.
The quantitative evaluation was performed by measuring the volume of residual gastric content according to the cross-sectional area (CSA) calculated from taking the anteroposterior (AP) and cephalocaudal (CC) diameters of the antrum measured from the layer of the gastric wall, applying the standard formula for the surface area: CSA = (AP x CC x p) / 4. The diameters were measured three times and the average of the three measurements was used as data. Gastric volume was calculated using the following formula validated in pediatrics by Spencer et al. (6): Gastric Volume = -7.8 + 3.5 x (CSA DLD cm2) + 0.127 x age (months).
Timepoint [2] 332545 0
1 hour after ingestion of a non-carbonated sports drink
Secondary outcome [1] 413874 0
Perioperative gastric regurgitation through clinical follow-up.
Timepoint [1] 413874 0
From the time of ingestion of a non-carbonated sports drink (3mL/kg) until 2 hours after surgery completion

Eligibility
Key inclusion criteria
Patients aged 11 months to 15 years, ASA I scheduled for outpatient surgery were included.
Minimum age
11 Months
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with a history of gastric or lower esophageal surgery were excluded, as they were considered at risk for bronchial aspiration.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Demographic and imaging characteristics were described in a frequency distribution table. The Kolmogorov-Smirnov test was applied, where a normal distribution was found in the continuous variables and they were described as percentages and standard deviations. Data were analyzed with Stata version 16.1 (StataCorp, Tx USA).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/08/2021
Date of last participant enrolment
Anticipated
Actual
14/01/2022
Date of last data collection
Anticipated
Actual
14/01/2022
Sample size
Target
42
Accrual to date
Final
50
Recruitment outside Australia
Country [1] 24967 0
Colombia
State/province [1] 24967 0
Caldas/Manizales

Funding & Sponsors
Funding source category [1] 312085 0
Self funded/Unfunded
Name [1] 312085 0
Alejandra Valencia
Country [1] 312085 0
Colombia
Funding source category [2] 312244 0
Self funded/Unfunded
Name [2] 312244 0
Alexander Trujillo
Country [2] 312244 0
Colombia
Primary sponsor type
Individual
Name
Alejandra Valencia
Address
Children´s Hospital Rafael henao Toro de la Cruz Roja Colombiana Seccional Caldas. Carrera 23 No.49-30, Manizales,
Country
Colombia
Secondary sponsor category [1] 313605 0
Individual
Name [1] 313605 0
Alexander Trujillo
Address [1] 313605 0
Children´s Hospital Rafael henao Toro de la Cruz Roja Colombiana Seccional Caldas. Carrera 23 No.49-30, Manizales,
Country [1] 313605 0
Colombia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311493 0
Ethics Committee of the Rafael Henao Toro Children's Hospital of the Colombian Red Cross, Caldas section
Ethics committee address [1] 311493 0
Ethics committee country [1] 311493 0
Colombia
Date submitted for ethics approval [1] 311493 0
Approval date [1] 311493 0
31/05/2021
Ethics approval number [1] 311493 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121294 0
Dr Alejandra Valencia Cataño
Address 121294 0
Children´s Hospital Rafael henao Toro de la Cruz Roja Colombiana Seccional Caldas. Carrera 23 No.49-30, Manizales,
Country 121294 0
Colombia
Phone 121294 0
+573175936136
Fax 121294 0
Email 121294 0
[email protected]
Contact person for public queries
Name 121295 0
Alejandra Valencia Cataño
Address 121295 0
Olga Clemencia Avila. Children´s Hospital Rafael henao Toro de la Cruz Roja Colombiana Seccional Caldas. Carrera 23 No.49-30, Manizales,
Country 121295 0
Colombia
Phone 121295 0
+573175936136
Fax 121295 0
Email 121295 0
[email protected]
Contact person for scientific queries
Name 121296 0
Alejandra Valencia Cataño
Address 121296 0
Olga clemencia Avila. Children´s Hospital Rafael henao Toro de la Cruz Roja Colombiana Seccional Caldas. Carrera 23 No.49-30, Manizales,
Country 121296 0
Colombia
Phone 121296 0
+573175936136
Fax 121296 0
Email 121296 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.