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NCT Number: NCT07581691

Evaluation of Preoperative Gastric Ultrasonography in Pediatric Patients in Terms of Patient Safety

Preoperative evaluation of stomach fullness with ultrasound in children who will undergo anesthesia outside the operating room

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Key information

Conditions

Nonoperating Room Anesthesia Gastric Ultrasound

Age range

0 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Erciyes University

Kayseri, Turkey (Türkiye)

Location status: Recruiting

Location contact

Erciyes U

CONTACT

About this study

Determining the gastric contents and volume by preoperative gastric ultrasound in pediatric patients and defining its relationship with the risk of postoperative aspiration.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children between 0-18 years of age and ASA I-II patients will be included in the study.

Exclusion criteria

  • Patients over 18 years of age,
  • ASA-III and above patients,
  • patients with gastrointestinal dysfunction,
  • patients who cannot assume the lateral decubitus position for gastric -ultrasound measurements,
  • those who have had previous lower esophageal or gastric surgery,
  • those who do not comply with institutional fasting guidelines,
  • those with concomitant systemic diseases affecting gastric emptying,
  • those with a high body mass index (BMI) > 40 kg/m2,
  • those with gastroesophageal reflux or aspiration risk factors, and emergency cases with delayed gastric emptying despite appropriate fasting time will not be included in the study.

Treatment and study plan

Primary outcomes

  1. Qualitative assessment of residual gastric fluid volume

    Time frame: preoperative evaluation in the operating room

    Grade 0: Defined as no contents visible in the antrum, the stomach is empty and the volume of the contents approaches zero.

    Grade 1: Visible clear fluid with a fluid volume of <1.5 mL/kg. Grade 2: Defined as visible clear fluid with a fluid volume of >1.5 mL/kg in both the supine and lateral decubitus positions.

Secondary outcomes

  1. Gastric content volume

    Time frame: preoperative evaluation in the operating room

    It will be calculated using a mathematical model validated in children aged 11 months to 18 years.

    Volume(mL/kg) = [-7.8 + 0.035 × antral area measured in lateral decubitus position (mm2) + 0.127 × age (months)] / body weight (kg). The R² value for this model was 0.60.

  2. Antral cross-sectional area

    Time frame: preoperative evaluation in the operating room

    In both supine and lateral decubitus positions, between antral contractions, serosa to serosa, measuring the length diameter (D1) and the anteroposterior diameter (D2); Antral area = (π × D1 × D2) / 4 will be measured using the formula.

Study contacts

Contact information is provided by the study sponsor or research team.

Özlem OZ GERGIN, MD

CONTACT

[email protected]

09005332466396

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

Evaluation of Preoperative Gastric Ultrasonography in Pediatric Patients in Terms of Patient Safety in Non-Operating Room Anesthesia Applications

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 12, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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