Residual Gastric Volume Measured by Ultrasound in Diabetic Surgical Population Versus Non-diabetic Surgical Population.

Comparative Observational Study of Residual Gastric Volume Measured by Ultrasound After Preoperative Fasting in a Diabetic Surgical Population Versus a Non-diabetic Surgical Population.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05435157

Enrollment

592

Registered

2022-06-28

Start date

2022-03-09

Completion date

2024-12-31

Last updated

2026-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Keywords

Diabetes mellitus, Gastric ultrasound, Full stomach, Surgery

Brief summary

Comparison of residual gastric volume measure by ultrasounds between diabetic and non-diabetic patients scheduled for elective surgery

Detailed description

The presence of gastric content increases the risk of aspiration during general anesthesia. Delayed gastric emptying has been described in diabetic patients; for that reason, diabetic patients could have a high risk of aspiration despite adequate fasting. This study aimed to compare ultrasound-guided measurement of residual gastric volume between diabetic and non-diabetic patients scheduled for elective surgery.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* BMI\<40 kg.m-2; * Age over 18 years; * American Society of Anesthesiologists' physical status status I-III * who were to undergo elective surgery and had the ability to understand the rationale of the study and provide informed consent

Exclusion criteria

* Pregnancy * Recent upper gastrointestinal bleed (\< 1 month) * Abnormal anatomy of the upper gastrointestinal tract (such as hiatal hernias and gastric tumors) * Previous surgical procedures on the esophagus, stomach, or upper abdomen * Gastroesophageal reflux disease * Previous use of prokinetics or high doses of opiates.

Design outcomes

Primary

Measure	Time frame	Description
Residual Gastric Volume	Preoperative	Residual gastric volume measured by ultrasounds as follows: Volume (mL) = 27.0 + 14.6 × CSARLD (cm²) - 1.28 × age (years)

Secondary

Measure	Time frame	Description
Antral Cross-Sectional Area	Preoperative	Antral cross-sectional area measured by ultrasounds

Countries

Spain

Contacts

PRINCIPAL_INVESTIGATORJosé A. Sastre, MD, PhD

Anesthesiology Service. Salamanca University Hospital

Baseline characteristics

Characteristic	—
Age, Continuous	66 years
Ethnicity (NIH/OMB) Hispanic or Latino	581 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Sex: Female, Male Female	80 Participants
Sex: Female, Male Male	141 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 216	0 / 144	0 / 221
other Total, other adverse events	0 / 216	0 / 144	0 / 221
serious Total, serious adverse events	0 / 216	0 / 144	0 / 221

Outcome results