NCT03594643

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 28, 2017

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2017

Completed
7 months until next milestone

First Posted

Study publicly available on registry

July 20, 2018

Completed
Last Updated

July 8, 2019

Status Verified

July 1, 2019

Enrollment Period

1.6 years

First QC Date

December 28, 2017

Last Update Submit

July 4, 2019

Conditions

Smoke Inhalation

Keywords

electronicsurgeryoutcomeanesthesiacigarette

Outcome Measures

Primary Outcomes (1)

  • electronic cigarette

    incidence of electronic cigarette that are used by patients

    1 day

Study Arms (2)

electronic cigarette

patient using electronic device, electronic cigarette

control

patient not smoking nor using electronic cigarette

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

\- This study include patients scheduled for elective surgery

You may qualify if:

  • protocol approval
  • patients scheduled for elective surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cuvillon

Nîmes, Gard, 30000, France

Location

MeSH Terms

Conditions

Smoke Inhalation Injury

Condition Hierarchy (Ancestors)

Burns, InhalationBurnsWounds and Injuries

Study Officials

  • jean.yves. Lefrant, MD,PhD

    Centre Hospitalier Universitaire de Nīmes

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,PhD

Study Record Dates

First Submitted

December 28, 2017

First Posted

July 20, 2018

Study Start

June 1, 2016

Primary Completion

December 30, 2017

Study Completion

December 30, 2017

Last Updated

July 8, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)