NCT06550492

Brief Summary

This study was conducted to determine and compare the effectiveness of the smoke filtering electrocautery device used to reduce the negative effects of surgical smoke and the use of a double layer mask.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

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

November 1, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 13, 2024

Completed
Last Updated

August 13, 2024

Status Verified

August 1, 2024

Enrollment Period

Same day

First QC Date

August 5, 2024

Last Update Submit

August 9, 2024

Conditions

Keywords

surgical smoke

Outcome Measures

Primary Outcomes (2)

  • Application Registration Form

    This form includes laboratory findings such as COHb, MetHb, PaO2, PaCO2, pH, HCO3, SpO2, Hg that may be affected in the person exposed to surgical smoke. In the study, it was examined whether exposure to surgical smoke affected these values.

    1 day

  • Questionnaire on Reported Health Problems

    The questionnaire form, which was created by the researcher by reviewing the literature on the subject, includes 45 health problems that may occur in the short term as a result of exposure to surgical smoke and a scale related to the frequency of experiencing these problems. in the questionnaire, the every day option shows the maximum value, the never option shows the minimum value

    1-2 day

Study Arms (3)

experimental group using smoke filtering electrocautery device

EXPERIMENTAL

experimental group using smoke filtering electrocautery device

Device: smoke filtering electrocautery device

experimental group using double mask

EXPERIMENTAL

experimental group using double mask

Other: double mask

control group

NO INTERVENTION

group using standard methods

Interventions

A smoke-filtering electrocautery device was used during surgery.

experimental group using smoke filtering electrocautery device

A double-layer mask was used during the operation.

experimental group using double mask

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • people over the age of 18.
  • People who agreed to participate in the study,
  • who have been working in the operating theatre for at least one year.
  • people who do not have chronic diseases Voluntary personnel who volunteered to co-operate were included in the study.

You may not qualify if:

  • People who did not agree to participate in the study,
  • persons who have been working in the operating theatre for less than one year
  • people with chronic diseases,
  • people who withdrew from the study before all data were collected
  • Personnel whose laboratory results could not be analysed were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atatürk University Health Application and Research Centre

Erzurum, Yakutiye, 25200, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Interventions

Double-Blind Method

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethodsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Zeynep Karaman Özlü, Professor

    zkaraman@atauni.edu.tr

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: experimental group using smoke filtering electrocautery device, experimental group using double mask and control group using single mask
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Researcher

Study Record Dates

First Submitted

August 5, 2024

First Posted

August 13, 2024

Study Start

November 1, 2023

Primary Completion

November 1, 2023

Study Completion

February 28, 2024

Last Updated

August 13, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations