Gastric Ultrasound in Diabetic and Non-Diabetic Pregnant Women

December 27, 2023 updated by: KAIRATBEK MIIZAMOV, Sisli Hamidiye Etfal Training and Research Hospital

Ultrasound Evaluation of Gastric Content in Diabetic and Non-Diabetic Term Pregnant Women: An Observational Study

Perioperative aspiration is particularly concerning in pregnant women due to anatomical changes. To mitigate this risk, pre-anesthetic fasting is recommended, with varying guidelines. Gastric ultrasound can non-invasively assess stomach contents, and mathematical models help estimate stomach volumes using the gastric antral cross-sectional area (CSA).

This study aims to compare CSA and estimated gastric volumes through ultrasound in fasting diabetic and non-diabetic pregnant women scheduled for cesarean section, as diabetes may affect stomach fullness. Additionally, it will investigate the relation between demographic and clinical variables and CSA values.

This research can shed light on diabetes' influence on aspiration risk in pregnancy and evaluate fasting guidelines, underscoring the significance of gastric ultrasound.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Perioperative aspiration of stomach contents is rare but is a serious complication of anesthesia and is associated with high morbidity and mortality. In pregnant women, it is known that the risk of aspiration is high even after standard preoperative fasting, due to anatomical changes such as the displacement of the stomach by pressure from the uterus, the sliding of the lower segment of the esophagus into the thorax, the relaxation of the lower esophageal sphincter, and the smooth muscle relaxation induced by progesterone.

In cases where regional anesthesia is contraindicated, various measures, including prokinetic and antacid medications, rapid-sequence anesthetic induction, and tracheal intubation, are used to reduce the risk and severity of pulmonary aspiration. However, the most commonly used measure is pre-anesthetic fasting in the patient. The European Society of Anaesthesiology (ESA) recommends fasting for ≥2 hours after clear liquids and 6 hours after light meals before elective surgery, including in pregnant patients.

The American Society of Anesthesiologists (ASA), on the other hand, recommends longer fasting times in pregnant patients without specifying the duration.

Aspiration risk in pregnant women is multifactorial. The type and volume of stomach contents, which are the main risk factors for aspiration, can be easily evaluated preoperatively with gastric ultrasonography. The presence of solids or thick liquids indicates a high risk of aspiration, independent of stomach volume.

However, in the presence of clear liquid, the risk of aspiration is generally linked to the volume of liquid in the stomach. The clear stomach volume limits that increase the risk of aspiration are controversial.

Some studies have shown that fasted patients generally have a gastric residual volume of up to 1.5 mL kg-1, and this value is used to determine the stomach at high risk for aspiration.

Gastric ultrasound assessment is an easy method that can be applied non-invasively at the bedside for evaluating gastric contents before anesthesia induction in the obstetric population. By measuring the gastric antral cross-sectional area (CSA), it may be possible to identify patients at risk for pulmonary aspiration with an estimate of stomach volume. Studies have shown the presence of a good linear correlation between antral CSA and stomach volume, not only in non-pregnant individuals but also in pregnant individuals.

Additionally, antral CSA measurement can indirectly differentiate small gastric volumes, consistent with initial gastric secretions, ≤1.5 mL kg-1, from larger volumes that may be associated with increased pulmonary aspiration risk.

Perlas et al. have developed a simple mathematical model based on the patient's age and antral CSA value measured in the right lateral position to calculate the volume of stomach fluid in non-pregnant adults and children.

Recently, two different mathematical models have been defined by Arzola et al.and Roukhomovsky et al. to estimate stomach volumes in pregnant patients. In this study, the investigators will use the mathematical formula developed by Roukhomovsky et al., as this model evaluates the presence of any stomach content, liquid or solid, rather than the volume of fluid swallowed as standard, with MR. Additionally, the model of Perlas et al., which is widely used in clinical practice and has been verified by studies, will be used.

It is accepted that there is gastroparesis in 9.9% - 76% of diabetic patients. Garg et al. in their prospective case-control study including 103 non-pregnant patients found that diabetic patients had higher gastric antral CSA and gastric volumes than non-diabetic patients. Sharma et al. have also shown that fasting for more than 6-10 hours does not guarantee an empty stomach and patients with comorbid diseases such as diabetes mellitus (DM), obesity are prone to having risky stomach contents. In DM patients, a significant increase in CSA in both supine and right lateral decubitus positions was detected compared to non-DM patients. Additionally, in the same study, it was found that as BMI increased from 25 to 35, there was a steady increase in CSA in both supine and right lateral decubitus positions. However, these studies were conducted in non-pregnant patients and the investigators did not come across similar studies conducted with diabetic pregnant women in the literature.

Recently, gastric ultrasound scanning before anesthesia in cases where the fasting state is unclear or unknown in the pregnant patient population, which is known to be more risky in terms of pulmonary aspiration, is recommended although not yet widespread in practical use. The effect of diabetes on stomach fullness is still controversial. There are many studies on gastric ultrasound evaluation in pregnant women, but the investigators have not come across a study comparing diabetic pregnant women with non-diabetics. This study was planned based on the idea that the presence of diabetes in pregnant women could further increase the risk of pulmonary aspiration. The primary aim of this research is to compare the antral cross-sectional area (CSA) with gastric ultrasound and estimated gastric volumes calculated with 2 mathematical models in fasting diabetic and non-diabetic term pregnant women who will be taken for cesarean section.

The secondary aim is to determine the relationship between demographic and clinical variables and gastric antral CSA values in fasting term pregnant women. the investigators believe that our study will contribute to the literature with its originality and results. Additionally, the investigators believe that our study will provide insight into the effectiveness of fasting guidelines in these patient groups and the necessity of gastric ultrasound scanning."

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
    • Istanbul
      • Sariyer, Istanbul, Turkey, 34396
        • Sisli Hamidiye Etfal Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

It is planned to include 80 diabetic and non-diabetic patients aged 18-40 years, belonging to the ASA (American Society of Anesthesiologists) physical status class II-III, who are scheduled for elective cesarean surgery. Randomization will be carried out using a sealed envelope method. Two groups, each comprising 40 patients, will be formed and evaluated with preoperative gastric ultrasound.

Description

Inclusion Criteria:

  • Patients belonging to American Society of Anesthesiology (ASA) physical status class II-III.
  • Aged between 18 and 40 years.
  • Gestational age greater than 37 weeks.
  • BMI< 35 kg/m2

Exclusion Criteria:

  • Patients belonging to American Society of Anesthesiology (ASA) physical status class III-IV.
  • Patients under the age of 18.
  • Patients taken to surgery on an emergency basis.
  • Relatives of patients who do not provide consent.
  • Pregnant patients with upper gastrointestinal (GI) diseases and pathologies.
  • Body Mass Index (BMI) greater than 35 kg/m2.
  • Patients with a history of using medications that affect gastrointestinal motility (e.g., opioids).
  • Severe organ dysfunction.
  • Pre-existing neurological deficits.
  • Intellectual disabilities.
  • Anatomical deformities.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Diabetic term pregnant patients
Compare the antral cross-sectional area (CSA) with gastric ultrasonography and estimated gastric volumes calculated with Perlas and Roukhomovsky mathematical models
Device: Gastric ultrasonography

It seems like the text you provided is already in Turkish and it appears to be written in an academic style. If you want this text to be translated to English in an academic language, it would be:

Ultrasonographic evaluation of gastric contents in Diabetic and Non-Diabetic term pregnancies
Non-Diabetic term pregnant patients
Compare the antral cross-sectional area (CSA) with gastric ultrasonography and estimated gastric volumes calculated with Perlas and Roukhomovsky mathematical models
Device: Gastric ultrasonography

It seems like the text you provided is already in Turkish and it appears to be written in an academic style. If you want this text to be translated to English in an academic language, it would be:

Ultrasonographic evaluation of gastric contents in Diabetic and Non-Diabetic term pregnancies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antral cross-sectional area (in square centimeters)
Time Frame: 2 months
Ultrasonographic gastric antral cross-sectional area in square centimeters=(D1 × D2 × π)/4. Anteroposterior diameter of the antrum from serosa to serosa: D1 (centimeters), craniocaudal diameter: D2 (centimeters)
2 months
Perlas equation for gastric volume (mL)
Time Frame: 2 months
Perlas Gastric residual volume (mL) = 27.0 + 14.6 x right lateral CSA (cm2) - 1.28 x age (years).
2 months
Roukhomovsky equation for gastric volume (mL)
Time Frame: 2 month
Roukhomovsky Gastric residual volume (mL) = 0.18 x right lateral CSA (mm2) + 0.11 x semi-recumbent CSA (mm2) - 62.4
2 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship between demographic/clinical features and CSA (cm2) / Perlas GV (mL/kg) / Roukhomovsky GV (mL/kg) values.
Time Frame: 2 months
The examination of the correlation/relationship between age (years), BMI (weight and height will be combined to report BMI in kg/m2), ASA (II-III), gestational age (weeks), fasting time for liquids (hour) and solids (hour), and supine CSA, right lateral CSA, Perlas GV (mL/kg) and Roukhomovsky GV (mL/kg) values.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Investigators

  • Principal Investigator: Sevgi Kesici, Assoc. Prof., Sisli Etfal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 26, 2023

Primary Completion (Actual)

December 10, 2023

Study Completion (Actual)

December 25, 2023

Study Registration Dates

First Submitted

July 7, 2023

First Submitted That Met QC Criteria

July 15, 2023

First Posted (Actual)

July 25, 2023

Study Record Updates

Last Update Posted (Actual)

December 29, 2023

Last Update Submitted That Met QC Criteria

December 27, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 709654

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pulmonary Aspiration

Clinical Trials on Gastric ultrasonography

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bulgaria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe