Pulmonary AspirationNCT06621706
Ultrasound Assessment of Gastric Volume in Diabetic Versus Non-Diabetic Term Pregnant Women Undergoing Cesarean Section
An observational study of Pulmonary Aspiration and Gastric Content Aspiration, run by Beni-Suef University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Pulmonary Aspiration, Gastric Content Aspiration
- What is being tested?
- Gastric ultrasonography
- Type of treatment
- Medical device
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Sep 2024to 25 Sep 2025
- 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
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Beni-Suef University hospital
Banī Suwayf, Beni Suweif Governorate, 62814
Dina M Fakhry, MD, +201289998680, dina_fakhry_91@yahoo.com
Dina Fakhry, MD, +201289998680, dina_fakhry_91@yahoo.com
About this study
Official title: Ultrasound Assessment of Gastric Volume in Diabetic Versus Non-Diabetic Term Pregnant Women Undergoing Elective Cesarean Section: A Prospective Randomized Clinical Trial
The aim of the work to compare estimated gastric volumes through ultrasound in fasting diabetic and non-diabetic pregnant women scheduled for caesarean section.
Read the 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.
- Conditions
- Pulmonary Aspiration, Gastric Content Aspiration
- Being tested
- Gastric ultrasonography
- Keywords
- Diabetic, Gastric ultrasonography, Pregnant
- Medical subject headings
- Respiratory Aspiration of Gastric Contents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric ultrasonographyDevice
Women will be requested to fast 2 hours for clear drinks, 6 hours for a light meal, and 8 hours for a meal high in fried or fatty content prior to their next antenatal clinic visit.
On the day of assessment, fasting and dietary compliance will be confirmed individually with each woman and Gastric ultrasonography will be performed after sex and eight hours of fasting food.
Women will be first scanned in a semi-recumbent (45 degrees head up) supine position, followed by a semi-recumbent (45 degrees head up) right lateral position (RLP). In both positions the gastric antrum will be identified in the sagittal plane with its internal anatomical landmarks identified, i.e. the left lobe of the liver anteriorly and the abdominal aorta posteriorly.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic term pregnant group | Compare the antral cross-sectional area (CSA) with gastric ultrasonography and estimated gastric volumes Receives: Device: Gastric ultrasonography | |
| Non-diabetic term pregnant group | Compare the antral cross-sectional area (CSA) with gastric ultrasonography and estimated gastric volumes Receives: Device: Gastric ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean antral cross-sectional area of stomach
mean antral cross-sectional area of stomach after 8 h of fasting in term pregnant diabetic and non-diabetic women undergoing elective caesarean section.
Measured: 8 hours of fasting
Secondary outcomes (2)
the mean antral cross-sectional area of stomach
mean antral cross-sectional area of stomach after 6 h of fasting presence of solid food contents in the gastric antrum,
Measured: 6 hours of fasting
gastric antral grade
The qualitative assessment of the gastric contents will be also done for presence of any clear fluid or solid food particles and a gastric antral grade, as described by Perlas et al. was designated based on the presence of fluid as follows: Grade 0 = absence of fluid in both supine and RLP; Grade 1 = fluid in RLP only; Grade 2 = fluid in both supine and RLPs
Measured: 6 and 8 hours of fasting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start25 Sep 2024
- Primary completion25 Sep 2025 (estimated)
- Study completion25 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary AspirationStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- 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
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Mahmoud Fakhry, Beni-Suef University
- Investigators
- Dina M Fakhry, MD, Principal investigator, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06621706
- Sponsor's protocol ID
- FMBSUREC/01092024/Fakhry
- Status last verified
- Sep 2024
- First submitted
- 29 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Assessment of Gastric Volume in Diabetic Versus Non-Diabetic Term Pregnant Women Undergoing Elective Cesarean Section: A Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06621706
- Acronym / sponsor ID
- FMBSUREC/01092024/Fakhry
- Conditions
- Pulmonary Aspiration, Gastric Content Aspiration
- Keywords
- Diabetic, Gastric ultrasonography, Pregnant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 25 Sep 2024 (actual)
- Primary completion
- 25 Sep 2025 (estimated)
- Study completion
- 25 Sep 2025 (estimated)
- First posted
- 1 Oct 2024 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic term pregnant group | – | Device: Gastric ultrasonographyCompare the antral cross-sectional area (CSA) with gastric ultrasonography and estimated gastric volumes |
| Non-diabetic term pregnant group | – | Device: Gastric ultrasonographyCompare the antral cross-sectional area (CSA) with gastric ultrasonography and estimated gastric volumes |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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 ultrasonographyWomen will be requested to fast 2 hours for clear drinks, 6 hours for a light meal, and 8 hours for a meal high in fried or fatty content prior to their next antenatal clinic visit. On the day of assessment, fasting and dietary compliance will be confirmed individually with each woman and Gastric ultrasonography will be performed after sex and eight hours of fasting food. Women will be first scanned in a semi-recumbent (45 degrees head up) supine position, followed by a semi-recumbent (45 degrees head up) right lateral position (RLP). In both positions the gastric antrum will be identified in the sagittal plane with its internal anatomical landmarks identified, i.e. the left lobe of the liver anteriorly and the abdominal aorta posteriorly. | Device | Diabetic term pregnant group, Non-diabetic term pregnant group |
Primary outcome
mean antral cross-sectional area of stomach
Time frame: 8 hours of fasting
mean antral cross-sectional area of stomach after 8 h of fasting in term pregnant diabetic and non-diabetic women undergoing elective caesarean section.
2 secondary outcomes
the mean antral cross-sectional area of stomach
Time frame: 6 hours of fasting
gastric antral grade
Time frame: 6 and 8 hours of fasting
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
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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.
Dina M Fakhry, MD principal investigator
Beni-Suef University
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 Pulmonary Aspiration and Gastric Content Aspiration, run by Beni-Suef University at 1 site in Egypt.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 1 Oct 2024. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dina M Fakhry, MD (+201289998680, dina_fakhry_91@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean antral cross-sectional area of stomach (time frame: 8 hours of fasting). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2024.