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Noise, a Risk for Heart in Airplane Pilots

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2007 by Universidad Politecnica de Madrid.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01063582
First Posted: February 5, 2010
Last Update Posted: February 5, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Universidad Politecnica de Madrid
  Purpose

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.


Condition Intervention
Pericarditis Other: exposure to occupational noise Procedure: cardiovascular valuation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Noise of Airplanes a Factor of Risk for the Health of the Heart in Pilots and Crew in Operations of the F16 Airplane

Resource links provided by NLM:


Further study details as provided by Universidad Politecnica de Madrid:

Primary Outcome Measures:
  • left ventricular systolic function [ Time Frame: one year ]

Secondary Outcome Measures:
  • electrical disturbance of the heart [ Time Frame: 15 days ]
  • study of the dimensions of cavities of the heart [ Time Frame: 15 days ]
  • haemodynamic study of the conditions [ Time Frame: 15 days ]
  • characterization of ambient sound military aero by Sound Level Meter [ Time Frame: 15 days ]
  • sensitivity analysis of noise dosimetry [ Time Frame: 15 days ]
  • subjective perception of noise [ Time Frame: 15 days ]
  • analysis of clinical background for selection of sample subjects [ Time Frame: 3 months ]

Enrollment: 16
Study Start Date: February 2005
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 noise
We performed the measurement of occupational noise exposure through sound level meter and Dosimeter during flight operations of F-16 fighter plane.
Other Name: occupational noise generated by aircraft miliary
Procedure: cardiovascular valuation
Cardiovascular valuation was performed via electrocardiogram and echocardiographic techniques to correlate the changes observed during exposure to occupational noise
Other Name: cardiovascular study
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 noise
We performed the measurement of occupational noise exposure through sound level meter and Dosimeter during flight operations of F-16 fighter plane.
Other Name: occupational noise generated by aircraft miliary
Procedure: cardiovascular valuation
Cardiovascular valuation was performed via electrocardiogram and echocardiographic techniques to correlate the changes observed during exposure to occupational noise
Other Name: cardiovascular study

Detailed Description:

The work area military airport is characterized by low frequency noise in sound pressure levels exceeding 100 dB, smashing into the body of pilots and ground staff.

It found variations in the thickness of the pericardium and deviation measures ejection fraction

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   26 Years to 37 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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
Criteria

Inclusion Criteria:

  • exposure to noise from military aircraft

Exclusion Criteria:

  • inactive personal or vacation
  Contacts and Locations
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): NCT01063582


Locations
Spain
Universidad Politécnica de Madrid
Madrid, Spain, 28006
Sponsors and Collaborators
Universidad Politecnica de Madrid
Investigators
Principal Investigator: Fredesvinda M Méndez, MSc Universidad Politecnica de Madrid
Study Director: Manuel Recuero, PhD Universidad Politecnica de Madrid
  More Information

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

Responsible Party: Fredesvinda Mendez, Universidad Politecnica de Madrid
ClinicalTrials.gov Identifier: NCT01063582     History of Changes
Other Study ID Numbers: FMendezV001
First Submitted: February 4, 2010
First Posted: February 5, 2010
Last Update Posted: February 5, 2010
Last Verified: January 2007

Keywords provided by Universidad Politecnica de Madrid:
echocardiogram
electrocardiographic
risk factors
noise

Additional relevant MeSH terms:
Pericarditis
Heart Diseases
Cardiovascular Diseases