NCT01063582

Brief Summary

Study of noise generated by military-type aircraft and equipment maintenance in relation to non-auditory effects that impact with the body of the crew and ground staff can cause cardiac pathologies Hypothesis of work: The pilots and the technical personnel of maintenance that work before the exhibition of noise generated by planes hunt F-16, or equipments of maintenance of the same ones, present major risk of a cardiac affectation, which demonstrates in changes in the normal pace of the heart, in his function of bomb or in hemodynamic conditions.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2005

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 5, 2010

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

February 5, 2010

Status Verified

January 1, 2007

Enrollment Period

7 months

First QC Date

February 4, 2010

Last Update Submit

February 4, 2010

Conditions

Keywords

echocardiogramelectrocardiographicrisk factorsnoise

Outcome Measures

Primary Outcomes (1)

  • left ventricular systolic function

    one year

Secondary Outcomes (7)

  • electrical disturbance of the heart

    15 days

  • study of the dimensions of cavities of the heart

    15 days

  • haemodynamic study of the conditions

    15 days

  • characterization of ambient sound military aero by Sound Level Meter

    15 days

  • sensitivity analysis of noise dosimetry

    15 days

  • +2 more secondary outcomes

Study Arms (2)

fighter pilots f-16

This group is made up of pilots from the F-16 Venezuelan military air force stationed in the Base Vicente Landaeta Gil de Barquisimeto, Lara State.

Other: exposure to occupational noiseProcedure: cardiovascular valuation

aircraft maintenance personnel f-16

Staff responsible for the preparation of aircraft for the flight and maintenance in the hangar at the airbase Vicente Landaeta Gil de Barquisimeto, Lara. Venezuela

Other: exposure to occupational noiseProcedure: cardiovascular valuation

Interventions

We performed the measurement of occupational noise exposure through sound level meter and Dosimeter during flight operations of F-16 fighter plane.

Also known as: occupational noise generated by aircraft miliary
aircraft maintenance personnel f-16fighter pilots f-16

Cardiovascular valuation was performed via electrocardiogram and echocardiographic techniques to correlate the changes observed during exposure to occupational noise

Also known as: cardiovascular study
aircraft maintenance personnel f-16fighter pilots f-16

Eligibility Criteria

Age26 Years - 37 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Group of subjects directly exposed to noise from military aircraft F-16 during its operation and maintenance at the airbase Vicente Landaeta Gil de Barquisimeto. Lara. Venezuela

You may qualify if:

  • exposure to noise from military aircraft

You may not qualify if:

  • inactive personal or vacation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Politécnica de Madrid

Madrid, Madrid, 28006, Spain

Location

Related Publications (7)

  • Jarup L, Babisch W, Houthuijs D, Pershagen G, Katsouyanni K, Cadum E, Dudley ML, Savigny P, Seiffert I, Swart W, Breugelmans O, Bluhm G, Selander J, Haralabidis A, Dimakopoulou K, Sourtzi P, Velonakis M, Vigna-Taglianti F; HYENA study team. Hypertension and exposure to noise near airports: the HYENA study. Environ Health Perspect. 2008 Mar;116(3):329-33. doi: 10.1289/ehp.10775.

    PMID: 18335099BACKGROUND
  • Andren L, Lindstedt G, Bjorkman M, Borg KO, Hansson L. Effect of noise on blood pressure and 'stress' hormones. Clin Sci (Lond). 1982 Feb;62(2):137-41. doi: 10.1042/cs0620137.

    PMID: 7053913BACKGROUND
  • ISO 1990 - International Organization for Standardization. Acoustics-Determination of occupational noise exposure and estimation of noise-induced hearing impairment. ISO 1999:1990 (E) Geneva ISO 1990

    BACKGROUND
  • ISO 1970 -International Organization for Standardization. Acoustics- Guide to international standards on the measurement of airborne acoustical noise and evaluation of its effects on human beings. ISO 2204-70 (E) Geneva ISO 1970.

    BACKGROUND
  • Rosenstock, L. Criteria for a recommended standard: occupational noise exposure. National Institute for Occupational Safety and Health. NIOSH, publication June 1998. 98-126.

    BACKGROUND
  • Tomei F, De Sio S, Tomao E, Anzelmo V, Baccolo TP, Ciarrocca M, Cherubini E, Valentini V, Capozzella A, Rosati MV. Occupational exposure to noise and hypertension in pilots. Int J Environ Health Res. 2005 Apr;15(2):99-106. doi: 10.1080/09603120500061534.

  • Tomei F, Papaleo B, Baccolo TP, Tomao E, Alfi P, Fantini S. [Chronic noise exposure and the cardiovascular system in aircraft pilots]. Med Lav. 1996 Sep-Oct;87(5):394-410. Italian.

MeSH Terms

Conditions

Pericarditis

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Fredesvinda M Méndez, MSc

    Universidad Politecnica de Madrid

    PRINCIPAL INVESTIGATOR
  • Manuel Recuero, PhD

    Universidad Politecnica de Madrid

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 4, 2010

First Posted

February 5, 2010

Study Start

February 1, 2005

Primary Completion

September 1, 2005

Study Completion

December 1, 2010

Last Updated

February 5, 2010

Record last verified: 2007-01

Locations