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Electronic Cigarette and Surgery (ECigarSurg) (ECigarSurg)

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ClinicalTrials.gov Identifier: NCT03594643
Recruitment Status : Completed
First Posted : July 20, 2018
Last Update Posted : July 20, 2018
Sponsor:
Collaborator:
Institut du Cancer de Montpellier - Val d'Aurelle
Information provided by (Responsible Party):
Philippe Cuvillon, Centre Hospitalier Universitaire de Nīmes

Brief Summary:

Since decades, literature has shown that smoking has negative effect on postoperative outcome. Recent systematic review and meta-analysis on clinical impact of smoking and smoking cessation showed that postoperative healing complications occur more often in smokers compared with nonsmokers.

The use of electronic cigarette (e-cigarette) is spreading through the world. Despite this fact, the health risk assessment studies on e-cigarette are limited and scientific evidences are inconsistent.

This prospective multicenter study aimed at assessing the use of e-cigarette whether patient undergoing elective surgery. The main objective of this study was to evaluate the prevalence of e-cigarette consumer in perioperative period. Secondary objectives were to analyze when patients consume e-cigarette in regard of surgery, how many dose they consume and if they also consume nicotine cigarette.


Condition or disease
Smoke Inhalation

Detailed Description:
this study used a standardized questionnaire that was filled in preoperative period

Study Type : Observational
Actual Enrollment : 1700 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Electronic Cigarette and Perianesthesia : a Prospective Multicentric Survey
Actual Study Start Date : June 1, 2016
Actual Primary Completion Date : December 30, 2017
Actual Study Completion Date : December 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes

Group/Cohort
electronic cigarette
patient using electronic device, electronic cigarette
control
patient not smoking nor using electronic cigarette



Primary Outcome Measures :
  1. electronic cigarette [ Time Frame: 1 day ]
    incidence of electronic cigarette that are used by patients



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
- This study include patients scheduled for elective surgery
Criteria

Inclusion Criteria:

  • protocol approval
  • patients scheduled for elective surgery

Exclusion Criteria:

  • < 18 ans
  • refusal
  • not speaking
  • emergency surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03594643


Locations
France
Cuvillon
Nîmes, Gard, France, 30000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Institut du Cancer de Montpellier - Val d'Aurelle
Investigators
Study Chair: jean.yves. Lefrant, MD,PhD Centre Hospitalier Universitaire de Nīmes

Responsible Party: Philippe Cuvillon, MD,PhD, Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT03594643     History of Changes
Other Study ID Numbers: 2017-Ecig-Nimes
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Philippe Cuvillon, Centre Hospitalier Universitaire de Nīmes:
electronic cigarette
surgery
outcome
anesthesia

Additional relevant MeSH terms:
Smoke Inhalation Injury
Burns, Inhalation
Burns
Wounds and Injuries