ClinicalTrials.gg
CompletedNCT05435157Updated Aug 13, 2026Results posted

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

An observational study in Diabetes Mellitus, sponsored by Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
592
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Diabetes Mellitus

Browse trials for

Keywords

  • Diabetes mellitus
  • Gastric ultrasound
  • Full stomach
  • Surgery
03

In context

Diabetes Mellitus

8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.

This study's enrollment of 592 is above the median of 246 across 1,936 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León is the lead sponsor of 15 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Fasted diabetic and non-diabetic patients scheduled for surgery.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
592 participants (actual)
Patient registry
No

Groups and cohorts

  • Diabetic patients

    Diabetic patients undergoing scheduled surgery

  • Non-diabetic patients

    Non-diabetic patients undergoing sheduled surgery

06

What researchers measure

Primary outcomes

  1. Residual Gastric Volume

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

    Time frame: Preoperative

Secondary outcomes

  1. Antral Cross-Sectional Area

    Antral cross-sectional area measured by ultrasounds

    Time frame: Preoperative

07

Results

Posted May 1, 2026

Participant flow

Participant flow — Overall Study
MilestoneDiabetic PatientsNon-diabetic PatientsDiabetic Patients With Dysautonomia
Started218152222
Completed216144221
Not completed281

Outcome measures

PrimaryResidual Gastric Volume

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

Time frame:
Preoperative
Reported as:
Median · mL
Residual Gastric Volume
mLDiabetic PatientsNon-diabetic PatientsDiabetic Patients With Dysautonomia
Residual Gastric Volume22.1 (-0.08 to 47.32)33.1 (9.8 to 67.1)40.2 (12.3 to 80.9)
Statistical analysis
  • Diabetic Patients vs Non-diabetic Patients vs Diabetic Patients With Dysautonomia · ANOVA · p = <0.05
  • Diabetic Patients vs Diabetic Patients With Dysautonomia · Risk ratio (rr): 0.05
SecondaryAntral Cross-Sectional Area

Antral cross-sectional area measured by ultrasounds

Time frame:
Preoperative
Reported as:
Median · cm2
Antral Cross-Sectional Area
cm2Diabetic PatientsNon-diabetic PatientsDiabetic Patients With Dysautonomia
Antral Cross-Sectional Area5.7 (4.1 to 7.1)5.4 (4.0 to 7.2)7.1 (5.2 to 9.3)
Statistical analysis
  • Diabetic Patients vs Non-diabetic Patients vs Diabetic Patients With Dysautonomia · ANOVA · p = <0.05
  • Diabetic Patients vs Diabetic Patients With Dysautonomia · Risk ratio (rr): 0.05

Adverse events

Collected over 1 day. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Diabetic Patients0/216 (0%)0/216 (0%)0/216 (0%)
Non-diabetic Patients0/144 (0%)0/144 (0%)0/144 (0%)
Diabetic Patients With Dysautonomia0/221 (0%)0/221 (0%)0/221 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Diabetic PatientsNon-diabetic PatientsDiabetic Patients With DysautonomiaTotal
Median70 (61 to 76)59 (50 to 69)72 (65 to 76)66 (64 to 68)
Sex: Female, Male
Sex: Female, Male(Participants)Diabetic PatientsNon-diabetic PatientsDiabetic Patients With DysautonomiaTotal
Female837580238
Male13369141343
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Diabetic PatientsNon-diabetic PatientsDiabetic Patients With DysautonomiaTotal
Hispanic or Latino216144221581
Not Hispanic or Latino0000
Unknown or Not Reported0000
08

Study locations

1 site
  • IBSAL
    Salamanca, 37007, Spain
09

References and documents

Publications

  • Sastre JA, Lopez T, Julian R, Bustos D, Sanchis-Dux R, Molero-Diez YB, Sanchez-Tabernero A, Ruiz-Simon FA, Sanchez-Hernandez MV, Gomez-Rios MA. Assessing Full Stomach Prevalence with Ultrasound Following Preoperative Fasting in Diabetic Patients with Dysautonomia: A Comparative Observational Study. Anesth Analg. 2024 Dec 1;139(6):1300-1308. doi: 10.1213/ANE.0000000000007110. Epub 2024 Aug 8. PubMed 39116006 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2022 to primary completion in Dec 2024, 33 months.

Results were first posted in May 2026, 1 year 4 months after primary completion.

Of 533 non-industry observational studies under Diabetes Mellitus, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 175. This study's 33 months is below that.

Counting every sponsor, half of 642 studies reached it within 36 months; a quarter within 14 and three quarters within 122.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 22, 2022
First posted
Jun 28, 2022
StartActual
Mar 9, 2022
Primary completionActual
Dec 31, 2024
CompletionActual
Dec 31, 2024
Results first posted
May 1, 2026
Last update
Aug 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05435157
Lead sponsor
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Responsible party
Jose Alfonso Sastre (Principal Investigator, Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León) — Principal investigator
First posted
Jun 28, 2022
Start date
Mar 9, 2022
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024
Results posted
May 1, 2026
Last update
Aug 13, 2026

Study contacts

José A. Sastre, MD, PhD
principal investigator · Anesthesiology Service. Salamanca University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion