PregnancyNCT05946447
Intra- and Interrater Reliability of Quantitative Ultrasound Assessment of Gastric Content in Term Parturients Before Elective Caesarean Delivery
A study testing Ultrasound in people with Pregnancy and Respiratory Aspiration of Gastric Content, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial summary
The presence of solid food or fluid residue in the stomach is always a major concern when patients require medical procedures under sedation or general anesthesia, due to the high risk of pulmonary aspiration of the stomach contents. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Respiratory Aspiration of Gastric Content
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 20 Jul 2023to 30 Oct 2023
- Phase
- Interventional
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- non-laboring term pregnant women scheduled for cesarean delivery under neuraxial anesthesia
- ≥37 weeks gestational age
- ≥18 years of age
- ASA physical status II-III
- weight 50 to 120 kg
- height ≥150 cm
- ability to understand the rationale of the study evaluations.
Who cannot join
- multiple pregnancy
- known (reported by the study subject) anomalous anatomy of the upper gastrointestinal tract
- previous surgical procedures on the esophagus, stomach or upper abdomen
- patients not following our institutional fasting instructions (8 hours after a meal and 2 hours for clear liquids)
Trial locations and contacts
1 site in 1 country.
About this study
The presence of solid food or fluid residue in the stomach is always a major concern when patients require medical procedures under sedation or general anesthesia, due to the high risk of pulmonary aspiration of the stomach contents. This is especially important in emergency procedures, when a fasting period could not be observed. Pulmonary aspiration of gastric content is a serious perioperative complication of obstetric anesthesia, and it is associated with morbidity and mortality. Information from a bedside ultrasound assessment of the stomach may be a very useful resource to decide whether it's safe to proceed, cancel or delay a surgical procedure. The ultrasound assessment of the stomach content has shown to be very feasible and practical in non-pregnant patients. However, it has not been determined whether the competence reached by anesthesiologists in non-pregnant subjects can be transferred to the obstetric population, especially in term pregnant patients where it could be difficult to identify the stomach because of the presence of the gravid uterus. Although quantitative assessment of the gastric antrum cross-sectional area in terms of intra- and interrater reliability has been evaluated in non-pregnant adults, it remains to be evaluated in pregnant patients. Furthermore, it has not been determined whether the performance of novice operators is comparable to expert operators in the gastric quantitative assessment. This study aims to determine whether trained anesthesiologists can reliably assess the stomach content of pregnant patients by ultrasound, evaluating the inter- and intra-rater reliability of quantitative gastric ultrasound in term pregnant patients comparing anesthesiologists of different level of expertise. The investigators hypothesize a substantial to almost perfect agreement in the intra- and interrater reliability of the antral cross-sectional area among raters in term pregnant patients scheduled for elective cesarean delivery.
- Being tested
- Ultrasound
- Keywords
- Gastric Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
Also called Gastric Ultrasound
The gastric antrum will be scanned using ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| Gastric Ultrasound | Experimental | Ultrasound measurements of the antrum will be recorded. Receives: Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antral cross-sectional area (supine position)
The cross-sectional area (in centimeters squared) of the antrum will be measured with the patient in supine position, using the ultrasound machine. Measurements will be done 3 times, by 2 investigators.
Measured: 5 minutes
Antral cross-sectional area (right lateral decubitus)
The cross-sectional area (in centimeters squared) of the antrum will be measured with the patient in right lateral decubitus position, using the ultrasound machine. Measurements will be done 3 times, by 2 investigators.
Measured: 5 minutes
Secondary outcomes (5)
Intra-rater reliability calculation
Intra-rater reliability will be calculated using the 3 measurements, for each rater.
Measured: 5 minutes
Inter-rater reliability calculation
Inter-rater reliability will be calculated using the 3 measurements, between raters.
Measured: 5 minutes
Grading of stomach contents
Grading scale: grade 0 means no gastric contents are visualized in supine and the right lateral decubitus, grade 1 means gastric contents are visualized in right lateral decubitus but not in supine decubitus, and grade 2 means gastric contents are visualized in both positions
Measured: 5 minutes
Gastric volume (supine position)
Gastric volume (ml) will be estimated using the antral cross-sectional area obtained with the patient in supine position
Measured: 5 minutes
Gastric volume (right lateral decubitus)
Gastric volume (ml) will be estimated using the antral cross-sectional area obtained with the patient in right lateral decubitus.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start20 Jul 2023
- Primary completion30 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cristian Arzola, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05946447
- Sponsor's protocol ID
- 23-02
- Status last verified
- Feb 2024
- First submitted
- 27 Jun 2023
- Last updated
- 23 Feb 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 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra- and Interrater Reliability of Quantitative Ultrasound Assessment of Gastric Content in Term Parturients Before Elective Caesarean Delivery
- ClinicalTrials.gov ID
- NCT05946447
- Acronym / sponsor ID
- 23-02
- Keywords
- Gastric Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 14 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.
The presence of solid food or fluid residue in the stomach is always a major concern when patients require medical procedures under sedation or general anesthesia, due to the high risk of pulmonary aspiration of the stomach contents. This is especially important in emergency procedures, when a fasting period could not be observed. Pulmonary aspiration of gastric content is a serious perioperative complication of obstetric anesthesia, and it is associated with morbidity and mortality. Information from a bedside ultrasound assessment of the stomach may be a very useful resource to decide whether it's safe to proceed, cancel or delay a surgical procedure. The ultrasound assessment of the stomach content has shown to be very feasible and practical in non-pregnant patients. However, it has not been determined whether the competence reached by anesthesiologists in non-pregnant subjects can be transferred to the obstetric population, especially in term pregnant patients where it could be difficult to identify the stomach because of the presence of the gravid uterus. Although quantitative assessment of the gastric antrum cross-sectional area in terms of intra- and interrater reliability has been evaluated in non-pregnant adults, it remains to be evaluated in pregnant patients. Furthermore, it has not been determined whether the performance of novice operators is comparable to expert operators in the gastric quantitative assessment. This study aims to determine whether trained anesthesiologists can reliably assess the stomach content of pregnant patients by ultrasound, evaluating the inter- and intra-rater reliability of quantitative gastric ultrasound in term pregnant patients comparing anesthesiologists of different level of expertise. The investigators hypothesize a substantial to almost perfect agreement in the intra- and interrater reliability of the antral cross-sectional area among raters in term pregnant patients scheduled for elective cesarean delivery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gastric Ultrasound | Experimental | Device: UltrasoundUltrasound measurements of the antrum will be recorded. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- non-laboring term pregnant women scheduled for cesarean delivery under neuraxial anesthesia
- ≥37 weeks gestational age
- ≥18 years of age
- ASA physical status II-III
- weight 50 to 120 kg
Key exclusion criteria (4 listed)
- multiple pregnancy
- known (reported by the study subject) anomalous anatomy of the upper gastrointestinal tract
- previous surgical procedures on the esophagus, stomach or upper abdomen
- patients not following our institutional fasting instructions (8 hours after a meal and 2 hours for clear liquids)
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 |
|---|---|---|
| UltrasoundAlso: Gastric UltrasoundThe gastric antrum will be scanned using ultrasound. | Device | Gastric Ultrasound |
Primary outcome
Antral cross-sectional area (supine position)
Time frame: 5 minutes
The cross-sectional area (in centimeters squared) of the antrum will be measured with the patient in supine position, using the ultrasound machine. Measurements will be done 3 times, by 2 investigators.
Antral cross-sectional area (right lateral decubitus)
Time frame: 5 minutes
The cross-sectional area (in centimeters squared) of the antrum will be measured with the patient in right lateral decubitus position, using the ultrasound machine. Measurements will be done 3 times, by 2 investigators.
5 secondary outcomes
Intra-rater reliability calculation
Time frame: 5 minutes
Inter-rater reliability calculation
Time frame: 5 minutes
Grading of stomach contents
Time frame: 5 minutes
Gastric volume (supine position)
Time frame: 5 minutes
Gastric volume (right lateral decubitus)
Time frame: 5 minutes
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 23 Feb 2024.
Related trials for Pregnancy
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
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.
Cristian Arzola, MD principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound in people with Pregnancy and Respiratory Aspiration of Gastric Content, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
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 7 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: finished, as of the sponsor's last update on 23 Feb 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 Canada. 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 (supine position) (time frame: 5 minutes). The study lists 2 primary outcomes in all. 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 23 Feb 2024.