Respiratory AspirationNCT01564030
Gastric Ultrasound in Pregnant Women at Term
A study testing Empty, Fluid and Solid 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 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Respiratory Aspiration, Pregnancy
- What is being tested?
- Empty, Fluid and Solid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2012to Jun 2012
- 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
- Volunteer non-laboring pregnant women >32 weeks gestation
- 18 years or older
- ASA status I-III
- Weigh between 50 and 120kg
- Height at least 150cm or taller
- Written informed consent
Who cannot join
- Known pre-existing abnormal anatomy of the upper GI tract
- Protocol violation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Qualitative Ultrasound Assessment of the Gastric Content of Pregnant Women at Term
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.
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 fo 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, fluid (250 mL of apple juice before scanning) or solid (full breakfast). Their gastric contents are then assessed by 3 different anesthesiologists, using ultrasound. At the end of the scanning, the true stomach contents are revealed. The ability of the assessors to accurately predict stomach contents, as well as the inter-observer agreement, will be examined.
- Conditions
- Respiratory Aspiration, Pregnancy
- Being tested
- Empty, Fluid, Solid
- 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.
EmptyOther
overnight fast
FluidOther
250mL apple juice
SolidOther
breakfast
| Study group | Role | What they receive |
|---|---|---|
| Empty stomach | Other | Patients have fasted for 8 hours. Receives: Other: Empty |
| Fluid | Other | Patients have fasted for 8 hours, followed by the consumption of 250mL of apple juice. Receives: Other: Fluid |
| Solid | Other | Patients have fasted for 8 hours, followed by the consumption of their breakfast. Receives: Other: Solid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability of the ultrasonographic diagnosis of the gastric status
Three physicians trained in gastric ultrasound will be blinded to the treatment group the patient was in, perform an ultrasound, and try to guess whether the patient has an empty stomach, consumed fluids only, or consumed a full meal.
Measured: 30 minutes
Secondary outcomes (1)
Inter-observer agreement of gastric content diagnosis
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose CA Carvalho, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01564030
- Sponsor's protocol ID
- 12-01
- Status last verified
- Nov 2012
- First submitted
- 23 Mar 2012
- Last updated
- 12 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Arzola C, Cubillos J, Perlas A, Downey K, Carvalho JC. Interrater reliability of qualitative ultrasound assessment of gastric content in the third trimester of pregnancy. Br J Anaesth. 2014 Dec;113(6):1018-23. doi: 10.1093/bja/aeu257. Epub 2014 Jul 30.
PubMed 25080428
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative Ultrasound Assessment of the Gastric Content of Pregnant Women at Term
- ClinicalTrials.gov ID
- NCT01564030
- Acronym / sponsor ID
- 12-01
- Conditions
- Respiratory Aspiration, Pregnancy
- Keywords
- Pregnancy, Respiratory aspiration, Gastric contents, Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 27 Mar 2012 (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.
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 fo 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, fluid (250 mL of apple juice before scanning) or solid (full breakfast). Their gastric contents are then assessed by 3 different anesthesiologists, using ultrasound. At the end of the scanning, the true stomach contents are revealed. The ability of the assessors to accurately predict stomach contents, as well as the inter-observer agreement, will be examined.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Empty stomach | Other | Other: EmptyPatients have fasted for 8 hours. |
| Fluid | Other | Other: FluidPatients have fasted for 8 hours, followed by the consumption of 250mL of apple juice. |
| Solid | Other | Other: SolidPatients have fasted for 8 hours, followed by the consumption of their breakfast. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Volunteer non-laboring pregnant women >32 weeks gestation
- 18 years or older
- ASA status I-III
- Weigh between 50 and 120kg
- Height at least 150cm or taller
Key exclusion criteria (2 listed)
- Known pre-existing abnormal anatomy of the upper GI tract
- Protocol violation
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 |
|---|---|---|
| Emptyovernight fast | Other | Empty stomach |
| Fluid250mL apple juice | Other | Fluid |
| Solidbreakfast | Other | Solid |
Primary outcome
Reliability of the ultrasonographic diagnosis of the gastric status
Time frame: 30 minutes
Three physicians trained in gastric ultrasound will be blinded to the treatment group the patient was in, perform an ultrasound, and try to guess whether the patient has an empty stomach, consumed fluids only, or consumed a full meal.
1 secondary outcome
Inter-observer agreement of gastric content diagnosis
Time frame: 30 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 12 Nov 2012.
- Derived from this study: PubMed 25080428Arzola C, Cubillos J, Perlas A, Downey K, Carvalho JC. Interrater reliability of qualitative ultrasound assessment of gastric content in the third trimester of pregnancy. Br J Anaesth. 2014 Dec;113(6):1018-23. doi: 10.1093/bja/aeu257. Epub 2014 Jul 30.
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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.
Jose CA Carvalho, 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 Empty, Fluid and Solid 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 6 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 12 Nov 2012. 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?
Reliability of the ultrasonographic diagnosis of the gastric status (time frame: 30 minutes). 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 NCT01564030, which also lists 1 linked publication.
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 12 Nov 2012.