Cesarean SectionNCT03842527
Gastric Voume Assessment for Aspiration Risk in OB ERAS Patients
A study testing Ultrasound in people with Cesarean Section, run by University of Calgary at 2 sites in Canada.
Trial summary
In recent years, human and animal studies have found that carbohydrate-loading prior to surgery leads to improved response to surgical stress and improved postoperative well-being when compared to traditional fasting guidelines. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesCanada
- Study dates
- 11 Feb 2019to 28 Feb 2020
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-laboring pregnant women
- ≥36 weeks gestational age
- scheduled elective cesarean delivery
- ≥18 years of age
- ASA physical status I to III
- weight 50 to 120 kg
- height ≥150 cm
- Ability to understand the rationale of the study assessments
Who cannot join
- multiple gestation
- abnormal anatomy of the upper gastrointestinal tract
- gestational diabetes or pre-existing diabetes mellitus
- previous surgical procedures on the esophagus, stomach, or upper abdomen
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Peter Lougheed Centre
Calgary, Alberta, T1Y 6J4
Foothills Medical Centre
Calgary, Alberta, T2N 2T9
About this study
Official title: Pre-Operative Gastric Volume Assessment Following Carbohydrate-Loading in Obstetrical Patients Undergoing Elective Cesarean Section: A Randomized Clinical Pilot Study
In recent years, human and animal studies have found that carbohydrate-loading prior to surgery leads to improved response to surgical stress and improved postoperative well-being when compared to traditional fasting guidelines. Such positive findings have lead to the increased use of preoperative intake of carbohydrate rich drinks prior to elective surgeries.
However, one of the biggest risks during surgery when a patient is asleep is having stomach contents come up into the lungs. For this reason, a stomach that is empty or has minimal amount of contents is safest. Historically, patients have been instructed not to eat or drink for 8 hours before surgery because it was thought to lower the risk of having fluid or contents in the stomach. This is the current practice patients are asked to follow before undergoing a C-section. However, non-pregnant patients undergoing other surgeries are instructed to have carbohydrate-rich drinks because of the potential benefits. Using ultrasound, the abdomen can be simply scanned to see if there are stomach contents present before surgery. This can allow for the potential determination of what the aspiration risk may be.
Read more
What the investigators want to do is look at the safety of using carbohydrate-loading in patients having a C-section. The investigators want to make sure that patients who follow carbohydrate-loading by having a clear, sugary drink 3 hours before a C-section are not at greater risk of having a large amount of stomach contents and be at higher risk of aspirating. This will be done by taking an ultrasound scan of the stomach that will tell the investigators if there are contents in the stomach and whether there is a risk of aspiration.
Patients having an elective C-section will be randomized into two groups. The first group will follow carbohydrate-loading by having a drink of apple juice or cranberry juice cocktail the night before (800mL) and 3 hours before (400mL) the C-section. The second group will follow standard practice of not eating or drinking less than 8 hours prior to surgery. An anesthesiologist will ultrasound the stomach 1 hour before the scheduled procedure time. The first ultrasound will be completed in the supine position (lying on back). The second will be done in the right lateral decubitus position (lying on right side). This should not take more than 5-10 minutes total.
- Conditions
- Cesarean Section
- Being tested
- Ultrasound
- Keywords
- Gastric Ultrasound, Carbohydrate Loading
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
Gastric ultrasound of the stomach antrum to assess contents 1 hour prior to C-section surgery. Scans will be completed in both supine (lying on back) and right lateral decubitus (positions) positions. The completion of both scans will take 5-10 minutes total
| Study group | Role | What they receive |
|---|---|---|
| Standard Fasting Group | Active comparator | Ultrasound scan of gastric antrum 1 hour prior to procedure. Patients assigned to this group will follow standard fasting procedures of no eating or drinking 8 hours prior to C-section. Receives: Device: Ultrasound |
| Carbohydrate Loading Group | Experimental | Ultrasound scan of gastric antrum 1 hour prior to procedure.
Patients assigned to this group must stop eating 8 hours prior to their scheduled C-section time.
The night before their C-section they must drink 800mL of 100% apple juice (not from concentrate) OR 800mL of cranberry juice cocktail, not both
The day of their C-section, starting 3 hours before surgery and to be finished 2 hours before surgery time, patients must drink 400mL of 100% apple juice OR 400mL of cranberry juice cocktail, not both
Please note:
* The apple juice must be 100% juice, not from concentrate
* The cranberry juice cocktail must not be plain cranberry juice Receives: Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Grade 2 antrum
Clear fluid is evident in antrum in both supine and right lateral decubitus scanning positions
Measured: 1 hour prior to C-section delivery
Secondary outcomes (3)
Incidence of Grade 0 antrum
Antrum appears empty in both supine and right lateral decubitus scanning positions
Measured: 1 hour prior to C-section
Incidence of Grade 1 antrum
Antrum appears empty in supine position, but clear fluid is visible in right lateral decubitus position
Measured: 1 hour prior to C-section
Cross-sectional antral area
Cross-sectional area measurement of the gastric antrum
Measured: 1 hour prior to C-section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start11 Feb 2019
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heather Hurdle, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03842527
- Sponsor's protocol ID
- REB17-2345
- Status last verified
- Jul 2020
- First submitted
- 13 Feb 2019
- Last updated
- 8 Jul 2020
- 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 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-Operative Gastric Volume Assessment Following Carbohydrate-Loading in Obstetrical Patients Undergoing Elective Cesarean Section: A Randomized Clinical Pilot Study
- ClinicalTrials.gov ID
- NCT03842527
- Acronym / sponsor ID
- REB17-2345
- Conditions
- Cesarean Section
- Keywords
- Gastric Ultrasound, Carbohydrate Loading
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 15 Feb 2019 (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.
In recent years, human and animal studies have found that carbohydrate-loading prior to surgery leads to improved response to surgical stress and improved postoperative well-being when compared to traditional fasting guidelines. Such positive findings have lead to the increased use of preoperative intake of carbohydrate rich drinks prior to elective surgeries.
However, one of the biggest risks during surgery when a patient is asleep is having stomach contents come up into the lungs. For this reason, a stomach that is empty or has minimal amount of contents is safest. Historically, patients have been instructed not to eat or drink for 8 hours before surgery because it was thought to lower the risk of having fluid or contents in the stomach. This is the current practice patients are asked to follow before undergoing a C-section. However, non-pregnant patients undergoing other surgeries are instructed to have carbohydrate-rich drinks because of the potential benefits. Using ultrasound, the abdomen can be simply scanned to see if there are stomach contents present before surgery. This can allow for the potential determination of what the aspiration risk may be.
What the investigators want to do is look at the safety of using carbohydrate-loading in patients having a C-section. The investigators want to make sure that patients who follow carbohydrate-loading by having a clear, sugary drink 3 hours before a C-section are not at greater risk of having a large amount of stomach contents and be at higher risk of aspirating. This will be done by taking an ultrasound scan of the stomach that will tell the investigators if there are contents in the stomach and whether there is a risk of aspiration.
Patients having an elective C-section will be randomized into two groups. The first group will follow carbohydrate-loading by having a drink of apple juice or cranberry juice cocktail the night before (800mL) and 3 hours before (400mL) the C-section. The second group will follow standard practice of not eating or drinking less than 8 hours prior to surgery. An anesthesiologist will ultrasound the stomach 1 hour before the scheduled procedure time. The first ultrasound will be completed in the supine position (lying on back). The second will be done in the right lateral decubitus position (lying on right side). This should not take more than 5-10 minutes total.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Fasting Group | Active comparator | Device: UltrasoundUltrasound scan of gastric antrum 1 hour prior to procedure. Patients assigned to this group will follow standard fasting procedures of no eating or drinking 8 hours prior to C-section. |
| Carbohydrate Loading Group | Experimental | Device: UltrasoundUltrasound scan of gastric antrum 1 hour prior to procedure. Patients assigned to this group must stop eating 8 hours prior to their scheduled C-section time. The night before their C-section they must drink 800mL of 100% apple juice (not from concentrate) OR 800mL of cranberry juice cocktail, not both The day of their C-section, starting 3 hours before surgery and to be finished 2 hours before surgery time, patients must drink 400mL of 100% apple juice OR 400mL of cranberry juice cocktail, not both Please note: * The apple juice must be 100% juice, not from concentrate * The cranberry juice cocktail must not be plain cranberry juice |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Non-laboring pregnant women
- ≥36 weeks gestational age
- scheduled elective cesarean delivery
- ≥18 years of age
- ASA physical status I to III
Key exclusion criteria (4 listed)
- multiple gestation
- abnormal anatomy of the upper gastrointestinal tract
- gestational diabetes or pre-existing diabetes mellitus
- previous surgical procedures on the esophagus, stomach, or upper abdomen
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 |
|---|---|---|
| UltrasoundGastric ultrasound of the stomach antrum to assess contents 1 hour prior to C-section surgery. Scans will be completed in both supine (lying on back) and right lateral decubitus (positions) positions. The completion of both scans will take 5-10 minutes total | Device | Carbohydrate Loading Group, Standard Fasting Group |
Primary outcome
Incidence of Grade 2 antrum
Time frame: 1 hour prior to C-section delivery
Clear fluid is evident in antrum in both supine and right lateral decubitus scanning positions
3 secondary outcomes
Incidence of Grade 0 antrum
Time frame: 1 hour prior to C-section
Incidence of Grade 1 antrum
Time frame: 1 hour prior to C-section
Cross-sectional antral area
Time frame: 1 hour prior to C-section
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 8 Jul 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 Cesarean Section, run by University of Calgary at 2 sites 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 8 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 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Incidence of Grade 2 antrum (time frame: 1 hour prior to C-section delivery). 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 8 Jul 2020.