AppendectomyEGASTANCT02983175
Ultrasound Assessment of Gastric Content Before Anesthesia for Appendectomy
A study testing ultrasound assessment of gastric content in people with Appendectomy, run by Central Hospital, Nancy, France.
Trial summary
Performing anesthetic induction for appendicectomy has two main risks : first aspiraion of gastric content causing pneumonia. Otherwise, anaphylactic risk to drugs used during anesthetic induction. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Appendectomy
- What is being tested?
- ultrasound assessment of gastric content
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Sep 2017
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient admitted to the operating room for appendectomy.
- Major or minor patient (higher than 16) affiliated to a social security scheme.
- Patient or parents of minor patient who received the full information relative to the organization of the study and who signed his/their informed consent(s).
Who cannot join
- Pregnant women.
- Childbearing age patient does not have effective contraception.
- Breastfeeding woman.
- Minor patient under 16.
- Major patient subject to a measure of legal protection or unable to consent.
- Persons deprived of liberty by a judicial or an administrative decision.
- Patient with gastric and/or esophagus surgery history.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Ultrasound Assessment of Gastric Content and Gastric Volume Before Crash Induction for Appendectomy
Performing anesthetic induction for appendicectomy has two main risks : first aspiraion of gastric content causing pneumonia. Otherwise, anaphylactic risk to drugs used during anesthetic induction. Indeed, the guidelines recommend an anesthetic induction protocol qualified "full stomach" whatever the patient and the preoperative fasting period are. This protocol provides the use of fast-acting neuromuscular blocking agents (succinylcholine or rocuronium). However, these neuromuscular blocking agents are ten times more at allergic risk than others. Ultrasound assessment of gastric content before rapid sequence induction of anesthesia is a reproducible, non-invasive, inexpensive and quickly achievable bedside technique. Furthermore, the correlations between gastric volume and risk of a full stomach and also between the cross-section antral area (CSA) and the risk of a full stomach have been validated on several patient cohorts. We formulate the hypothesis that the achievement of a gastric ultrasound before anesthetic induction for appendectomy could allow to identify "full stomach" patients who actually justify rapid sequence induction of anesthesia with exposure to fast-acting neuromuscular blocking agents that implies.
Primary endpoint is to determine te percentage of patients who have a gastric content before appendectomy. Secondary endpoint is to determine the incidenc of aspiration pneumonia and anaphylactic shock. Another secondary endpoint is to determine the percentage of patient with gastric content with the antral grading system (Perlas method) and to evaluate the concordance between this methode and the cross-section antral area.
- Conditions
- Appendectomy
- Being tested
- ultrasound assessment of gastric content
- Keywords
- ultrasonogaphy, full stomach, pulmonary aspiration, anaesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound assessment of gastric contentOther
Achievement of gastric ultrasound (specific procedure) :
Gastric ultrasound is performed specifically for the study by a senior anesthetist physician in a patient placed supine, semi-sitting by an angle of 45 ° relative to the horizontal.
Standardised achievement of the antral ultrasound by the following method:
- First, a qualitative assessment of antral contents in 3 grades according to the "Perlas" method [24].
- Second, performing a quantitative analysis of antral contents calculating the CSA.
- Then, volume of gastric contents calculation as from the CSA.
| Study group | Role | What they receive |
|---|---|---|
| ultrasound assessment of gastric content | Experimental | Not described Receives: Other: ultrasound assessment of gastric content |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cross-section antral area (CSA)
Ultrasonography exam of the stomach is used to evaluate the CSA. A CSA greater than 340mm² defines a full stomach. The calculation of the CSA is : CSA = AP x CC x π / 4 (in mm²). With AP - antero-posterior gastric antrum diameter and CC - cranio-caudal gastric antrum diameter
Measured: baseline J0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionAug 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AppendectomyStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02983175
- Sponsor's protocol ID
- 2016-A01501-50
- Acronym
- EGASTA
- Status last verified
- Dec 2016
- First submitted
- 2 Dec 2016
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bouvet L, Mazoit JX, Chassard D, Allaouchiche B, Boselli E, Benhamou D. Clinical assessment of the ultrasonographic measurement of antral area for estimating preoperative gastric content and volume. Anesthesiology. 2011 May;114(5):1086-92. doi: 10.1097/ALN.0b013e31820dee48.
PubMed 21364462Perlas A, Chan VW, Lupu CM, Mitsakakis N, Hanbidge A. Ultrasound assessment of gastric content and volume. Anesthesiology. 2009 Jul;111(1):82-9. doi: 10.1097/ALN.0b013e3181a97250.
PubMed 19512861Reddy JI, Cooke PJ, van Schalkwyk JM, Hannam JA, Fitzharris P, Mitchell SJ. Anaphylaxis is more common with rocuronium and succinylcholine than with atracurium. Anesthesiology. 2015 Jan;122(1):39-45. doi: 10.1097/ALN.0000000000000512.
PubMed 25405395
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Assessment of Gastric Content and Gastric Volume Before Crash Induction for Appendectomy
- ClinicalTrials.gov ID
- NCT02983175
- Acronym / sponsor ID
- EGASTA / 2016-A01501-50
- Conditions
- Appendectomy
- Keywords
- ultrasonogaphy, full stomach, pulmonary aspiration, anaesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 6 Dec 2016 (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.
Performing anesthetic induction for appendicectomy has two main risks : first aspiraion of gastric content causing pneumonia. Otherwise, anaphylactic risk to drugs used during anesthetic induction. Indeed, the guidelines recommend an anesthetic induction protocol qualified "full stomach" whatever the patient and the preoperative fasting period are. This protocol provides the use of fast-acting neuromuscular blocking agents (succinylcholine or rocuronium). However, these neuromuscular blocking agents are ten times more at allergic risk than others. Ultrasound assessment of gastric content before rapid sequence induction of anesthesia is a reproducible, non-invasive, inexpensive and quickly achievable bedside technique. Furthermore, the correlations between gastric volume and risk of a full stomach and also between the cross-section antral area (CSA) and the risk of a full stomach have been validated on several patient cohorts. We formulate the hypothesis that the achievement of a gastric ultrasound before anesthetic induction for appendectomy could allow to identify "full stomach" patients who actually justify rapid sequence induction of anesthesia with exposure to fast-acting neuromuscular blocking agents that implies.
Primary endpoint is to determine te percentage of patients who have a gastric content before appendectomy. Secondary endpoint is to determine the incidenc of aspiration pneumonia and anaphylactic shock. Another secondary endpoint is to determine the percentage of patient with gastric content with the antral grading system (Perlas method) and to evaluate the concordance between this methode and the cross-section antral area.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ultrasound assessment of gastric content | Experimental | Other: ultrasound assessment of gastric content |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patient admitted to the operating room for appendectomy.
- Major or minor patient (higher than 16) affiliated to a social security scheme.
- Patient or parents of minor patient who received the full information relative to the organization of the study and who signed his/their informed consent(s).
Key exclusion criteria (7 listed)
- Pregnant women.
- Childbearing age patient does not have effective contraception.
- Breastfeeding woman.
- Minor patient under 16.
- Major patient subject to a measure of legal protection or unable to consent.
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 |
|---|---|---|
| ultrasound assessment of gastric contentAchievement of gastric ultrasound (specific procedure) : Gastric ultrasound is performed specifically for the study by a senior anesthetist physician in a patient placed supine, semi-sitting by an angle of 45 ° relative to the horizontal. Standardised achievement of the antral ultrasound by the following method: * First, a qualitative assessment of antral contents in 3 grades according to the "Perlas" method [24]. * Second, performing a quantitative analysis of antral contents calculating the CSA. * Then, volume of gastric contents calculation as from the CSA. | Other | ultrasound assessment of gastric content |
Primary outcome
Cross-section antral area (CSA)
Time frame: baseline J0
Ultrasonography exam of the stomach is used to evaluate the CSA. A CSA greater than 340mm² defines a full stomach. The calculation of the CSA is : CSA = AP x CC x π / 4 (in mm²). With AP - antero-posterior gastric antrum diameter and CC - cranio-caudal gastric antrum diameter
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2016.
- Results publication: PubMed 21364462Bouvet L, Mazoit JX, Chassard D, Allaouchiche B, Boselli E, Benhamou D. Clinical assessment of the ultrasonographic measurement of antral area for estimating preoperative gastric content and volume. Anesthesiology. 2011 May;114(5):1086-92. doi: 10.1097/ALN.0b013e31820dee48.
- Results publication: PubMed 19512861Perlas A, Chan VW, Lupu CM, Mitsakakis N, Hanbidge A. Ultrasound assessment of gastric content and volume. Anesthesiology. 2009 Jul;111(1):82-9. doi: 10.1097/ALN.0b013e3181a97250.
- Results publication: PubMed 25405395Reddy JI, Cooke PJ, van Schalkwyk JM, Hannam JA, Fitzharris P, Mitchell SJ. Anaphylaxis is more common with rocuronium and succinylcholine than with atracurium. Anesthesiology. 2015 Jan;122(1):39-45. doi: 10.1097/ALN.0000000000000512.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound assessment of gastric content in people with Appendectomy, run by Central Hospital, Nancy, France.
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 3 inclusion and 7 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 6 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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 Marie-Alix REGNIER-KIMMOUN, PH (03.83.85.14.03 ext. +33, ma.regnier@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cross-section antral area (CSA) (time frame: baseline J0). 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 NCT02983175, which also lists 3 linked publications.
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 6 Dec 2016.