Gastric Ultrasound in Diabetic and Non-Diabetic Pregnant Women

NCT05959135 | Completed

• 1 other identifier: 709654
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastric Ultrasonography; Gastric Volume; Pulmonary Aspiration; Diabetic Pregnancy; Fasting

Keywords

Diabetic Pregnant Women; Gastric ultrasonography; Gastric Contents; Gastric volume; Antral sectional area; Pregnant women

Outcome Measures

Primary Outcomes (3)

• Antral cross-sectional area (in square centimeters)

  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)

  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)

  Roukhomovsky Gastric residual volume (mL) = 0.18 x right lateral CSA (mm2) + 0.11 x semi-recumbent CSA (mm2) - 62.4

  2 month

Secondary Outcomes (1)

• Relationship between demographic/clinical features and CSA (cm2) / Perlas GV (mL/kg) / Roukhomovsky GV (mL/kg) values.

  2 months

Study Arms (2)

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

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

Interventions

Gastric ultrasonography DEVICE

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

Diabetic term pregnant patients; Non-Diabetic term pregnant patients

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Term pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

Study Sites (1)

Sisli Hamidiye Etfal Training and Research Hospital

Sarıyer, Istanbul, 34396, Turkey (Türkiye)

Location

Related Publications (15)

• MENDELSON CL. The aspiration of stomach contents into the lungs during obstetric anesthesia. Am J Obstet Gynecol. 1946 Aug;52:191-205. doi: 10.1016/s0002-9378(16)39829-5. No abstract available.

  PMID: 20993766 RESULT

• Smith I, Kranke P, Murat I, Smith A, O'Sullivan G, Soreide E, Spies C, in't Veld B; European Society of Anaesthesiology. Perioperative fasting in adults and children: guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2011 Aug;28(8):556-69. doi: 10.1097/EJA.0b013e3283495ba1.

  PMID: 21712716 RESULT

• Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures: An Updated Report by the American Society of Anesthesiologists Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology. 2017 Mar;126(3):376-393. doi: 10.1097/ALN.0000000000001452. No abstract available.

  PMID: 28045707 RESULT

• El-Boghdadly K, Wojcikiewicz T, Perlas A. Perioperative point-of-care gastric ultrasound. BJA Educ. 2019 Jul;19(7):219-226. doi: 10.1016/j.bjae.2019.03.003. Epub 2019 Apr 24. No abstract available.

  PMID: 33456894 RESULT

• Van de Putte P, Perlas A. Ultrasound assessment of gastric content and volume. Br J Anaesth. 2014 Jul;113(1):12-22. doi: 10.1093/bja/aeu151. Epub 2014 Jun 3.

  PMID: 24893784 RESULT

• Van de Putte P, Vernieuwe L, Perlas A. Term pregnant patients have similar gastric volume to non-pregnant females: a single-centre cohort study. Br J Anaesth. 2019 Jan;122(1):79-85. doi: 10.1016/j.bja.2018.07.025. Epub 2018 Aug 29.

  PMID: 30579409 RESULT

• Arzola C, Perlas A, Siddiqui NT, Carvalho JCA. Bedside Gastric Ultrasonography in Term Pregnant Women Before Elective Cesarean Delivery: A Prospective Cohort Study. Anesth Analg. 2015 Sep;121(3):752-758. doi: 10.1213/ANE.0000000000000818.

  PMID: 26097988 RESULT

• Perlas A, Chan VW, Lupu CM, Mitsakakis N, Hanbidge A. Ultrasound assessment of gastric content and volume. Anesthesiology. 2009 Jul;111(1):82-9. doi: 10.1097/ALN.0b013e3181a97250.

  PMID: 19512861 RESULT

• Perlas A, Van de Putte P, Van Houwe P, Chan VW. I-AIM framework for point-of-care gastric ultrasound. Br J Anaesth. 2016 Jan;116(1):7-11. doi: 10.1093/bja/aev113. Epub 2015 May 7. No abstract available.

  PMID: 25951832 RESULT

• Perlas A, Mitsakakis N, Liu L, Cino M, Haldipur N, Davis L, Cubillos J, Chan V. Validation of a mathematical model for ultrasound assessment of gastric volume by gastroscopic examination. Anesth Analg. 2013 Feb;116(2):357-63. doi: 10.1213/ANE.0b013e318274fc19. Epub 2013 Jan 9.

  PMID: 23302981 RESULT

• Arzola C, Perlas A, Siddiqui NT, Downey K, Ye XY, Carvalho JCA. Gastric ultrasound in the third trimester of pregnancy: a randomised controlled trial to develop a predictive model of volume assessment. Anaesthesia. 2018 Mar;73(3):295-303. doi: 10.1111/anae.14131. Epub 2017 Dec 19.

  PMID: 29265187 RESULT

• Roukhomovsky M, Zieleskiewicz L, Diaz A, Guibaud L, Chaumoitre K, Desgranges FP, Leone M, Chassard D, Bouvet L; AzuRea, CAR'Echo Collaborative Networks. Ultrasound examination of the antrum to predict gastric content volume in the third trimester of pregnancy as assessed by MRI: A prospective cohort study. Eur J Anaesthesiol. 2018 May;35(5):379-389. doi: 10.1097/EJA.0000000000000749.

  PMID: 29210844 RESULT

• Jellish WS, Kartha V, Fluder E, Slogoff S. Effect of metoclopramide on gastric fluid volumes in diabetic patients who have fasted before elective surgery. Anesthesiology. 2005 May;102(5):904-9. doi: 10.1097/00000542-200505000-00007.

  PMID: 15851875 RESULT

• Garg H, Podder S, Bala I, Gulati A. Comparison of fasting gastric volume using ultrasound in diabetic and non-diabetic patients in elective surgery: An observational study. Indian J Anaesth. 2020 May;64(5):391-396. doi: 10.4103/ija.IJA_796_19. Epub 2020 May 1.

  PMID: 32724247 RESULT

• Sharma G, Jacob R, Mahankali S, Ravindra MN. Preoperative assessment of gastric contents and volume using bedside ultrasound in adult patients: A prospective, observational, correlation study. Indian J Anaesth. 2018 Oct;62(10):753-758. doi: 10.4103/ija.IJA_147_18.

  PMID: 30443057 RESULT

MeSH Terms

Conditions

Diabetes, Gestational; Fasting

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Feeding Behavior; Behavior

Study Officials

• Sevgi Kesici, Assoc. Prof.

  Sisli Etfal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: July 25, 2023
• Study Start: July 26, 2023
• Primary Completion: December 10, 2023
• Study Completion: December 25, 2023
• Last Updated: December 29, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)