Preoperative Residual Gastric Volume

NCT ID: NCT07031414

Last Updated: 2025-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-15

Study Completion Date

2025-08-15

Brief Summary

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The goal of this observational study is to assess the preoperative gastric residual volume in adult patients undergoing elective surgery. The main question it aims to answer is:

Does gastric residual volume, content type, and aspiration risk differ between diabetic and non-diabetic patients with similar fasting durations?

Participants undergoing elective surgery will receive bedside gastric ultrasound as part of their preoperative assessment. Ultrasound images will be used to estimate gastric volume and evaluate aspiration risk.

Detailed Description

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The goal of this observational study is to assess whether bedside gastric ultrasound can identify differences in residual gastric volume, content type, and aspiration risk in adult diabetic and non-diabetic patients (ages 18-65) undergoing elective surgery under general anesthesia.

The main questions it aims to answer are:

Do diabetic patients have higher residual gastric volume than non-diabetic patients despite similar fasting durations?

Does the type or amount of gastric content differ between the two groups, potentially increasing aspiration risk?

Researchers will compare diabetic and non-diabetic groups to see if diabetes is associated with delayed gastric emptying and increased aspiration risk.

Participants will:

Undergo bedside gastric ultrasound prior to anesthesia induction

Be scanned in semi-sitting and right lateral decubitus positions using a convex ultrasound probe

Have gastric antrum graded and volume calculated

Be evaluated for aspiration risk based on validated ultrasound criteria

Conditions

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Preoperative Gastric Residual Volume

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Diabetic Group - Patients with a diagnosis of diabetes mellitus Non-Diabetic Group - Patients witho

Diabetic Group Adult patients (aged 18-65) with a known diagnosis of diabetes mellitus who are scheduled for elective surgery under general anesthesia.

These participants will undergo preoperative bedside gastric ultrasound to evaluate residual gastric volume, content type, and aspiration risk.

Non-Diabetic Group Adult patients (aged 18-65) without diabetes mellitus, scheduled for elective surgery under general anesthesia.

These participants will also undergo preoperative bedside gastric ultrasound for the same assessments as the diabetic group.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Aged 18 to 65 years,
* American Society of Anesthesiologists (ASA) physical status I -III
* Scheduled for elective surgery under general anesthesia.
* Patients with a known history of diabetes mellitus will be included in the diabetic group.

Exclusion Criteria

* Pregnant patients
* Patients with gastrointestinal obstructive diseases
* Patients with gastroesophageal reflux disease
* History of gastrointestinal surgery
* Emergency surgery cases
* Recent history of abdominal trauma
* Non-diabetic patients with autonomic or neurological disorders
* Patients with chronic kidney disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Izmir City Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Derya Arslan Yurtlu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Derya A. Yurtlu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Izmir City Hospital, Izmir, TURKEY

Locations

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University of Health Sciences, Izmir Faculty of Medicine, Izmir City Hospital

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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IZMIR CITY HOSPİTAL

Identifier Type: OTHER

Identifier Source: secondary_id

IZMIR CITY HOSPİTAL

Identifier Type: -

Identifier Source: org_study_id

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