Cigarette and Gastric Contents

November 18, 2014 updated by: Lionel Bouvet
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69003
        • Hôpital Edouard Herriot

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA 1 or 2 Volunteers habitual smokers = 5 cigarettes / day during at least 1 year

Exclusion Criteria:

  • Digestive Diseases, gastroparesis
  • Non smokers
  • pregnancy
  • history of diabetes mellitus
  • medication affecting gastric motility
  • previous gastrointestinal surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Controle
The volunteer do not smoke any cigarette during the study period
Experimental: smoking
the volunteer smokes 2 cigarettes in 15 minutes
Behavioral: 2 cigarettes in 15 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Variation of the ultrasonographically measured antral area afer smoking or non smoking cigarette
Time Frame: every 30 minutes during 2h30
every 30 minutes during 2h30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lionel Bouvet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

March 4, 2014

First Submitted That Met QC Criteria

March 4, 2014

First Posted (Estimate)

March 6, 2014

Study Record Updates

Last Update Posted (Estimate)

November 19, 2014

Last Update Submitted That Met QC Criteria

November 18, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 2014-A00127-40
  • L14-12 (Other Identifier: Comité de Protection des Personnes Sud Est IV)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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