Clinical trial NCT06621706: Ultrasound Assessment of Gastric Volume in Diabetic Versus Non-Diabetic Term Pregnant Women Undergoing Cesarean Section
Official title: Ultrasound Assessment of Gastric Volume in Diabetic Versus Non-Diabetic Term Pregnant Women Undergoing Elective Cesarean Section: A Prospective Randomized Clinical Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Aspiration
Gastric Content Aspiration
Keywords: Diabetic
Gastric ultrasonography
Pregnant
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: mean antral cross-sectional area of stomach
timeFrame: 8 hours of fasting
Secondary outcomes:
measure: the mean antral cross-sectional area of stomach
timeFrame: 6 hours of fasting
measure: gastric antral grade
timeFrame: 6 and 8 hours of fasting
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni-Suef University hospital
state: Beni Suef
Study officials:
affiliation: Beni-Suef University
name: Dina M Fakhry, MD
role: PRINCIPAL_INVESTIGATOR
References: