Gastric UltrasonographyNCT05959135
Gastric Ultrasound in Diabetic and Non-Diabetic Pregnant Women
An observational study of Gastric Ultrasonography and Gastric Volume, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gastric Ultrasonography, Gastric Volume, Pulmonary Aspiration
- What is being tested?
- Gastric ultrasonography
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Jul 2023to 25 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sisli Hamidiye Etfal Training and Research Hospital
Sarıyer, Istanbul, 34396
About this study
Official title: Ultrasound Evaluation of Gastric Content in Diabetic and Non-Diabetic Term Pregnant Women: An Observational Study
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.
Read the detailed description
Perioperative aspiration of stomach contents is rare but is a serious complication of anesthesia and is associated with high morbidity and mortality. In pregnant women, it is known that the risk of aspiration is high even after standard preoperative fasting, due to anatomical changes such as the displacement of the stomach by pressure from the uterus, the sliding of the lower segment of the esophagus into the thorax, the relaxation of the lower esophageal sphincter, and the smooth muscle relaxation induced by progesterone.
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
- Gastric Ultrasonography, Gastric Volume, Pulmonary Aspiration, Diabetic Pregnancy, Fasting
- Being tested
- Gastric ultrasonography
- Keywords
- Diabetic Pregnant Women, Gastric ultrasonography, Gastric Contents, Gastric volume, Antral sectional area, Pregnant women
- Medical subject headings
- Diabetes, Gestational, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric ultrasonographyDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Gastric ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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).
Measured: 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
Measured: 2 month
Secondary outcomes (1)
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start26 Jul 2023
- Primary completion10 Dec 2023
- Study completion25 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Gastric UltrasonographyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KAIRATBEK MIIZAMOV, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- Sevgi Kesici, Assoc. Prof., Principal investigator, Sisli Etfal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05959135
- Sponsor's protocol ID
- 709654
- Status last verified
- Dec 2023
- First submitted
- 7 Jul 2023
- Last updated
- 29 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20993766Smith 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.
PubMed 21712716Practice 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.
PubMed 28045707El-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.
PubMed 33456894Van 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.
PubMed 24893784Van 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.
PubMed 30579409Arzola 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.
PubMed 26097988Perlas 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.
PubMed 19512861Perlas 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.
PubMed 25951832Perlas 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.
PubMed 23302981Arzola 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.
PubMed 29265187Roukhomovsky 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.
PubMed 29210844Jellish 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.
PubMed 15851875Garg 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.
PubMed 32724247Sharma 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.
PubMed 30443057
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Evaluation of Gastric Content in Diabetic and Non-Diabetic Term Pregnant Women: An Observational Study
- ClinicalTrials.gov ID
- NCT05959135
- Acronym / sponsor ID
- 709654
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 26 Jul 2023 (actual)
- Primary completion
- 10 Dec 2023 (actual)
- Study completion
- 25 Dec 2023 (actual)
- First posted
- 25 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Perioperative aspiration of stomach contents is rare but is a serious complication of anesthesia and is associated with high morbidity and mortality. In pregnant women, it is known that the risk of aspiration is high even after standard preoperative fasting, due to anatomical changes such as the displacement of the stomach by pressure from the uterus, the sliding of the lower segment of the esophagus into the thorax, the relaxation of the lower esophageal sphincter, and the smooth muscle relaxation induced by progesterone.
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."
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic term pregnant patients | – | Device: Gastric ultrasonographyCompare the antral cross-sectional area (CSA) with gastric ultrasonography and estimated gastric volumes calculated with Perlas and Roukhomovsky mathematical models |
| Non-Diabetic term pregnant patients | – | Device: Gastric ultrasonographyCompare the antral cross-sectional area (CSA) with gastric ultrasonography and estimated gastric volumes calculated with Perlas and Roukhomovsky mathematical models |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastric ultrasonographyIt 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 | Device | Diabetic term pregnant patients, Non-Diabetic term pregnant patients |
Primary outcome
Antral cross-sectional area (in square centimeters)
Time frame: 2 months
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)
Perlas equation for gastric volume (mL)
Time frame: 2 months
Perlas Gastric residual volume (mL) = 27.0 + 14.6 x right lateral CSA (cm2) - 1.28 x age (years).
Roukhomovsky equation for gastric volume (mL)
Time frame: 2 month
Roukhomovsky Gastric residual volume (mL) = 0.18 x right lateral CSA (mm2) + 0.11 x semi-recumbent CSA (mm2) - 62.4
1 secondary outcome
Relationship between demographic/clinical features and CSA (cm2) / Perlas GV (mL/kg) / Roukhomovsky GV (mL/kg) values.
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
- Results publication: PubMed 20993766MENDELSON 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.
- Results publication: PubMed 21712716Smith 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.
- Results publication: PubMed 28045707Practice 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.
- Results publication: PubMed 33456894El-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.
- Results publication: PubMed 24893784Van 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.
- Results publication: PubMed 30579409Van 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.
- Results publication: PubMed 26097988Arzola 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.
- Results publication: PubMed 19512861Perlas 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.
- Results publication: PubMed 25951832Perlas 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.
- Results publication: PubMed 23302981Perlas 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.
- Results publication: PubMed 29265187Arzola 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.
- Results publication: PubMed 29210844Roukhomovsky 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.
- Individual participant dataSharing planned: No
Related trials for Gastric Ultrasonography
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Anaesthetic Management in Patients Undergoing Coronary Artery Bypass Grafting
Preoperative Fasting, Pulmonary Aspiration During Anesthetic Induction
Not yet recruitingObservational study
Serum Estradiol and Endometrial Thickness After Bariatric Surgery in Postmenopausal Women With Obesity
Obesity, Morbid, Postmenopause
Not yet recruitingObservational study
Preoperative Gastric Volume and PONV in Pediatric Appendectomy Cases
Postoperative Nausea and Vomiting
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sevgi Kesici, Assoc. Prof. principal investigator
Sisli Etfal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Ultrasonography and Gastric Volume, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antral cross-sectional area (in square centimeters) (time frame: 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05959135, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2023.