Variation of the Antral Area After Cigarettes Smoking or NotNCT02080598
Cigarette and Gastric Contents
A study testing 2 cigarettes in 15 minutes in people with Variation of the Antral Area After Cigarettes Smoking or Not, run by Lionel Bouvet at 1 site in France.
Trial summary
The aims of this cross over prospective study are to demonstrate that smoking two cigarettes do not change the gastric contents and volume in fasting volunteers. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Variation of the Antral Area After Cigarettes Smoking or Not
- What is being tested?
- 2 cigarettes in 15 minutes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to Nov 2014
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA 1 or 2 Volunteers habitual smokers = 5 cigarettes / day during at least 1 year
Who cannot join
- Digestive Diseases, gastroparesis
- Non smokers
- pregnancy
- history of diabetes mellitus
- medication affecting gastric motility
- previous gastrointestinal surgery
Trial locations and contacts
1 site in 1 country.
About this study
The aims of this cross over prospective study are to demonstrate that smoking two cigarettes do not change the gastric contents and volume in fasting volunteers.
- Being tested
- 2 cigarettes in 15 minutes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 cigarettes in 15 minutesBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Controle | No intervention | The volunteer do not smoke any cigarette during the study period |
| smoking | Experimental | the volunteer smokes 2 cigarettes in 15 minutes Receives: Behavioral: 2 cigarettes in 15 minutes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of the ultrasonographically measured antral area afer smoking or non smoking cigarette
Measured: every 30 minutes during 2h30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionNov 2014
- Study completionNov 2014
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 Variation of the Antral Area After Cigarettes Smoking or NotStudies 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
- Crossover
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lionel Bouvet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lionel Bouvet, Hôpital Edouard Herriot
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080598
- Sponsor's protocol ID
- 2014-A00127-40
- Other IDs
- L14-12
- Status last verified
- Nov 2014
- First submitted
- 4 Mar 2014
- Last updated
- 19 Nov 2014
- Results posted
- No
Publications
Lazaar S, Boselli E, Chassard D, Allaouchiche B, Bouvet L. Effect of acute cigarette smoking on gastric contents in regular smoker volunteers. A prospective randomized cross-over study. Br J Anaesth. 2015 Oct;115(4):590-4. doi: 10.1093/bja/aev264. Epub 2015 Aug 30.
PubMed 26323291
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cigarette and Gastric Contents
- ClinicalTrials.gov ID
- NCT02080598
- Acronym / sponsor ID
- 2014-A00127-40
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Lionel BouvetUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 6 Mar 2014 (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.
The aims of this cross over prospective study are to demonstrate that smoking two cigarettes do not change the gastric contents and volume in fasting volunteers.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controle | No intervention | –The volunteer do not smoke any cigarette during the study period |
| smoking | Experimental | Behavioral: 2 cigarettes in 15 minutesthe volunteer smokes 2 cigarettes in 15 minutes |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA 1 or 2 Volunteers habitual smokers = 5 cigarettes / day during at least 1 year
Key exclusion criteria (6 listed)
- Digestive Diseases, gastroparesis
- Non smokers
- pregnancy
- history of diabetes mellitus
- medication affecting gastric motility
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 |
|---|---|---|
| 2 cigarettes in 15 minutes | Behavioural | smoking |
Primary outcome
Variation of the ultrasonographically measured antral area afer smoking or non smoking cigarette
Time frame: every 30 minutes during 2h30
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 19 Nov 2014.
- Derived from this study: PubMed 26323291Lazaar S, Boselli E, Chassard D, Allaouchiche B, Bouvet L. Effect of acute cigarette smoking on gastric contents in regular smoker volunteers. A prospective randomized cross-over study. Br J Anaesth. 2015 Oct;115(4):590-4. doi: 10.1093/bja/aev264. Epub 2015 Aug 30.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2 cigarettes in 15 minutes in people with Variation of the Antral Area After Cigarettes Smoking or Not, run by Lionel Bouvet at 1 site in 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 1 inclusion and 6 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 19 Nov 2014. 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 France. 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?
Variation of the ultrasonographically measured antral area afer smoking or non smoking cigarette (time frame: every 30 minutes during 2h30). 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 NCT02080598, 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 19 Nov 2014.