Gastric Ultrasound in Diabetic and Non-Diabetic Pregnant Women
NCT ID: NCT05959135
Last Updated: 2023-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
80 participants
OBSERVATIONAL
2023-07-26
2023-12-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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."
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
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
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Aged between 18 and 40 years.
* Gestational age greater than 37 weeks.
* BMI\< 35 kg/m2
Exclusion Criteria
* 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.
18 Years
40 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sisli Hamidiye Etfal Training and Research Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
KAIRATBEK MIIZAMOV
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sevgi Kesici, Assoc. Prof.
Role: PRINCIPAL_INVESTIGATOR
Sisli Etfal
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sisli Hamidiye Etfal Training and Research Hospital
Sarıyer, Istanbul, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
709654
Identifier Type: -
Identifier Source: org_study_id