Fasting Clinical Trial
Official title:
Ultrasound Evaluation of Gastric Content in Diabetic and Non-Diabetic Term Pregnant Women: An Observational Study
NCT number | NCT05959135 |
Other study ID # | 709654 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 26, 2023 |
Est. completion date | December 25, 2023 |
Verified date | December 2023 |
Source | Sisli Hamidiye Etfal Training and Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | December 25, 2023 |
Est. primary completion date | December 10, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Sisli Hamidiye Etfal Training and Research Hospital | Sariyer | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Sisli Hamidiye Etfal Training and Research Hospital |
Turkey,
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. — View Citation
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/ana — View Citation
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. — View Citation
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 M — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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.0b013e318274 — View Citation
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. — View Citation
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 Tas — View Citation
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 pregn — View Citation
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.IJ — View Citation
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 — View Citation
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. — View Citation
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. — View Citation
* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Antral cross-sectional area (in square centimeters) | Ultrasonographic gastric antral cross-sectional area in square centimeters=(D1 × D2 × p)/4. Anteroposterior diameter of the antrum from serosa to serosa: D1 (centimeters), craniocaudal diameter: D2 (centimeters) | 2 months | |
Primary | 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 | |
Primary | 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 | Relationship between demographic/clinical features and CSA (cm2) / Perlas GV (mL/kg) / Roukhomovsky GV (mL/kg) values. | 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 |
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