Respiratory AspirationNCT01980108
Quantitative Ultrasound Assessment of Gastric Volume in Pregnant Women at Term
A study testing water in people with Respiratory Aspiration and Pregnancy, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial summary
Solid food or fluid residue in the stomach is always a major concern when patients need 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 is not observed. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Respiratory Aspiration, Pregnancy
- What is being tested?
- water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2013to Feb 2016
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteer non-labouring pregnant women at term (≥ 36 weeks)-
- 18 years or older
- ASA Physical Status I-III
- 50-120 kg of weight
- 150 cm of height or taller
- Ability to understand the rationale of the study assessments and to provide signed informed consent
- Written informed consent
Who cannot join
- Known pre-existing abnormal anatomy of the upper gastrointestinal tract
- History of upper GI tract surgical procedure
Trial locations and contacts
1 site in 1 country.
About this study
Solid food or fluid residue in the stomach is always a major concern when patients need 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 is not observed. The aspiration of the stomach contents into one's lungs can lead to serious complications (such as severe respiratory failure). Information from a bedside ultrasound assessment of the stomach may be a very useful tool to decide whether or not it's safe to proceed, cancel or delay a surgical procedure.
The investigotrs hypothesize that a mathematical model can be constructed to predict clear fluid volume in the stomach of non-labouring pregnant patients, as it has been developed in healthy adult volunteers.
Read the detailed description
Food residue in the stomach of patients scheduled to have surgery is considered a major risk factor for pulmonary aspiration of gastric contents. The resulting respiratory compromise after aspiration is associated with significant morbidity and mortality. The risk of pulmonary aspiration is especially important in pregnant women, as they may often require surgery without having observed appropriate fasting. A bedside ultrasound assessment of the status of the gastric content would be of great value for the clinician. This technique has recently been shown very promising in non-pregnant patients and it is important to study its feasibility in the pregnant population.
In this study, patients fast overnight and are randomized to the following groups: empty, or various volumes of fluid (50, 100, 200, 300 or 400mL of apple juice before scanning). Their gastric contents are then assessed by an anesthesiologist, using ultrasound. The investigators aim to evaluate a standardized quantitative ultrasound assessment of gastric volume in non-labouring pregnant women.
- Conditions
- Respiratory Aspiration, Pregnancy
- Being tested
- water
- Keywords
- Pregnancy, Respiratory Aspiration, Gastric Contents, Ultrasound
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
waterOther
water
| Study group | Role | What they receive |
|---|---|---|
| empty stomach | No intervention | No fluid will be given to the patient prior to scanning. |
| 50mL | Experimental | 50mL of water will be given to the patient prior to scanning Receives: Other: water |
| 100mL | Experimental | 100mL of water will be given to the patient prior to scanning Receives: Other: water |
| 200mL | Experimental | 200mL of water will be given to the patient prior to scanning Receives: Other: water |
| 300mL | Experimental | 300mL of water will be given to the patient prior to scanning Receives: Other: water |
| 400mL | Experimental | 400mL of water will be given to the patient prior to scanning Receives: Other: water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between ingested volume and CSA in antrum
The patient will ingest 0, 50, 100, 200, 300 or 400mL of apple juice, and then the cross-sectional area (CSA) will be measured.
Measured: 5-10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory AspirationStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 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
- NCT01980108
- Sponsor's protocol ID
- 13-07
- Status last verified
- Apr 2016
- First submitted
- 4 Nov 2013
- Last updated
- 2 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Ultrasound Assessment of Gastric Volume in Pregnant Women at Term
- ClinicalTrials.gov ID
- NCT01980108
- Acronym / sponsor ID
- 13-07
- Conditions
- Respiratory Aspiration, Pregnancy
- Keywords
- Pregnancy, Respiratory Aspiration, Gastric Contents, Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 8 Nov 2013 (estimated)
- 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.
Solid food or fluid residue in the stomach is always a major concern when patients need 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 is not observed. The aspiration of the stomach contents into one's lungs can lead to serious complications (such as severe respiratory failure). Information from a bedside ultrasound assessment of the stomach may be a very useful tool to decide whether or not it's safe to proceed, cancel or delay a surgical procedure.
The investigotrs hypothesize that a mathematical model can be constructed to predict clear fluid volume in the stomach of non-labouring pregnant patients, as it has been developed in healthy adult volunteers.
Detailed description
Food residue in the stomach of patients scheduled to have surgery is considered a major risk factor for pulmonary aspiration of gastric contents. The resulting respiratory compromise after aspiration is associated with significant morbidity and mortality. The risk of pulmonary aspiration is especially important in pregnant women, as they may often require surgery without having observed appropriate fasting. A bedside ultrasound assessment of the status of the gastric content would be of great value for the clinician. This technique has recently been shown very promising in non-pregnant patients and it is important to study its feasibility in the pregnant population.
In this study, patients fast overnight and are randomized to the following groups: empty, or various volumes of fluid (50, 100, 200, 300 or 400mL of apple juice before scanning). Their gastric contents are then assessed by an anesthesiologist, using ultrasound. The investigators aim to evaluate a standardized quantitative ultrasound assessment of gastric volume in non-labouring pregnant women.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| empty stomach | No intervention | –No fluid will be given to the patient prior to scanning. |
| 50mL | Experimental | Other: water50mL of water will be given to the patient prior to scanning |
| 100mL | Experimental | Other: water100mL of water will be given to the patient prior to scanning |
| 200mL | Experimental | Other: water200mL of water will be given to the patient prior to scanning |
| 300mL | Experimental | Other: water300mL of water will be given to the patient prior to scanning |
| 400mL | Experimental | Other: water400mL of water will be given to the patient prior to scanning |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Volunteer non-labouring pregnant women at term (≥ 36 weeks)-
- 18 years or older
- ASA Physical Status I-III
- 50-120 kg of weight
- 150 cm of height or taller
Key exclusion criteria (2 listed)
- Known pre-existing abnormal anatomy of the upper gastrointestinal tract
- History of upper GI tract surgical procedure
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 |
|---|---|---|
| waterwater | Other | 100mL, 200mL, 300mL, 400mL, 50mL |
Primary outcome
Correlation between ingested volume and CSA in antrum
Time frame: 5-10 minutes
The patient will ingest 0, 50, 100, 200, 300 or 400mL of apple juice, and then the cross-sectional area (CSA) will be measured.
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 2 May 2016.
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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.
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 water in people with Respiratory Aspiration and Pregnancy, 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 2 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 2 May 2016. 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?
Correlation between ingested volume and CSA in antrum (time frame: 5-10 minutes). 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 2 May 2016.