Ultrasound Assessment of Gastric Volume in Diabetic Versus Non-Diabetic Term Pregnant Women Undergoing Cesarean Section

Ultrasound Assessment of Gastric Volume in Diabetic Versus Non-Diabetic Term Pregnant Women Undergoing Elective Cesarean Section: A Prospective Randomized Clinical Trial

The aim of the work to compare estimated gastric volumes through ultrasound in fasting diabetic and non-diabetic pregnant women scheduled for caesarean section.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Aspiration; Gastric Content Aspiration
• Intervention / Treatment: Device: Gastric ultrasonography

Detailed Description

Fasting is a mandatory requirement prior to elective anesthesia and is intended to reduce gastric fluid volume and the risk of aspiration of gastric contents and subsequent organ injury. Aspiration of gastric contents during perioperative period is a grave complication with significant morbidity and mortality and its severity depends upon the gastric volume and nature of the aspirate.

A high-risk stomach refers to a gastric volume associated with an increased risk of pulmonary aspiration and is defined in most published literature as the presence of any solid or liquid content >1.5 mL/kg Pregnant women have been considered to be at particular risk of aspiration syndromes as a consequence of physiological changes during pregnancy which lead to relaxation of lower oesophageal sphincter and mechanical upward displacement of the stomach by the enlarged uterus.

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. In contrast, the American Society of Anesthesiology guidelines specifically exclude pregnant women and the Society for Obstetric Anesthesia and Perinatology taskforce recommended a fasting period of 6-8 hours, depending on the nature of food ingested.

Diabetic patients can present with diabetic gastropathy, an autonomic neuropathy associated with delayed gastric emptying in the absence of gastric outlet obstruction tend, predisposing them to increased risk of aspiration as compared to non-diabetic patients.

To date, standard fasting guidelines for people with diabetes are still up for debate.. European Society of Anaesthesiology (ESA) 2011 Fasting guidelines state that diabetic patients can follow the same guidelines as healthy adults, While American Society of Anesthesiologists (ASA) in 2017 fasting guidelines mentioned that the standard eight hours fasting may not apply or may need to be modified for patients with coexisting diseases or conditions that can affect gastric emptying or fluid volume.

With the advent of portable ultrasound machines, performing point-of-care ultrasound has become relatively easy and feasible. Gastric ultrasound examination is finding a place as a point-of-care tool for aspiration risk assessment. It can identify the nature and the volume of the gastric content, i.e., empty, clear fluid and solid and when clear fluid is present, its volume can be quantified.

In this study, we will analyse the stomach contents of Non-labouring term pregnant women after six and eight hours of fasting, using previously described qualitative and quantitative ultrasonographic assessments.

• Study Type: Observational
• Enrollment (Estimated): 140

Contacts and Locations

• Study Contact: Name: Dina M Fakhry, MD; Phone Number: +201289998680; Email: dina_fakhry_91@yahoo.com

Study Locations

• Egypt
  • Beni Suef
    • Banī Suwayf, Beni Suef, Egypt, 62814
      • Recruiting
      • Beni-suef university Hospital
      • Contact: Dina M Fakhry, MD; Phone Number: +201289998680; Email: dina_fakhry_91@yahoo.com
      • Contact: Dina Fakhry, MD; Phone Number: +201289998680; Email: dina_fakhry_91@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Eligible 140 patients are aged from 18-40 years, with an American Society of Anaesthesiologists (ASA) physical status of II-III, and are scheduled to undergo elective caesarean section.

Description

Inclusion Criteria:

• pregnant women undergoing elective caesarean section
• aged between 18-40 years
• belonging to ASA II-III
• gestational age greater than 37 weeks
• BMI< 35 kg/m2

Exclusion Criteria:

• patients who refuse to give consent
• patients taken to surgery on an emergency basis, -pregnant patients with upper gastrointestinal (GI) diseases and pathologies
• patients with a history of using medications that affect gastrointestinal motility (e.g., opioids), severe organ dysfunction
• pre-existing neurological deficits, intellectual disabilities and anatomical deformities.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Diabetic term pregnant group; Compare the antral cross-sectional area (CSA) with gastric ultrasonography and estimated gastric volumes	Device: Gastric ultrasonography; Women will be requested to fast 2 hours for clear drinks, 6 hours for a light meal, and 8 hours for a meal high in fried or fatty content prior to their next antenatal clinic visit. On the day of assessment, fasting and dietary compliance will be confirmed individually with each woman and Gastric ultrasonography will be performed after sex and eight hours of fasting food. Women will be first scanned in a semi-recumbent (45 degrees head up) supine position, followed by a semi-recumbent (45 degrees head up) right lateral position (RLP). In both positions the gastric antrum will be identified in the sagittal plane with its internal anatomical landmarks identified, i.e. the left lobe of the liver anteriorly and the abdominal aorta posteriorly.
Non-diabetic term pregnant group; Compare the antral cross-sectional area (CSA) with gastric ultrasonography and estimated gastric volumes	Device: Gastric ultrasonography; Women will be requested to fast 2 hours for clear drinks, 6 hours for a light meal, and 8 hours for a meal high in fried or fatty content prior to their next antenatal clinic visit. On the day of assessment, fasting and dietary compliance will be confirmed individually with each woman and Gastric ultrasonography will be performed after sex and eight hours of fasting food. Women will be first scanned in a semi-recumbent (45 degrees head up) supine position, followed by a semi-recumbent (45 degrees head up) right lateral position (RLP). In both positions the gastric antrum will be identified in the sagittal plane with its internal anatomical landmarks identified, i.e. the left lobe of the liver anteriorly and the abdominal aorta posteriorly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean antral cross-sectional area of stomach	mean antral cross-sectional area of stomach after 8 h of fasting in term pregnant diabetic and non-diabetic women undergoing elective caesarean section.	8 hours of fasting

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the mean antral cross-sectional area of stomach	mean antral cross-sectional area of stomach after 6 h of fasting presence of solid food contents in the gastric antrum,	6 hours of fasting
gastric antral grade	The qualitative assessment of the gastric contents will be also done for presence of any clear fluid or solid food particles and a gastric antral grade, as described by Perlas et al. was designated based on the presence of fluid as follows: Grade 0 = absence of fluid in both supine and RLP; Grade 1 = fluid in RLP only; Grade 2 = fluid in both supine and RLPs	6 and 8 hours of fasting

Collaborators and Investigators

• Sponsor: Beni-Suef University
• Investigators: Principal Investigator: Dina M Fakhry, MD, Beni-Suef University

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2024
• Primary Completion (Estimated): September 25, 2025
• Study Completion (Estimated): September 25, 2025

Study Registration Dates

• First Submitted: September 29, 2024
• First Submitted That Met QC Criteria: September 29, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 29, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Diabetic; Pregnant; Gastric ultrasonography
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux; Laryngopharyngeal Reflux; Respiratory Aspiration; Respiratory Aspiration of Gastric Contents
• Other Study ID Numbers: FMBSUREC/01092024/Fakhry

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No