Clinical trial NCT01063582: Noise, a Risk for Heart in Airplane Pilots
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pericarditis
Keywords: echocardiogram
electrocardiographic
risk factors
noise
Lead sponsor: Universidad Politecnica de Madrid
Sponsor class: OTHER
First posted: 2010-02-05
Enrollment: 16
Sex: MALE
Minimum age (years): 26
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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

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.

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 criteria: Inclusion Criteria:

* exposure to noise from military aircraft

Exclusion Criteria:

* inactive personal or vacation

Primary outcomes:
measure: left ventricular systolic function
timeFrame: one year
Secondary outcomes:
measure: electrical disturbance of the heart
timeFrame: 15 days
measure: study of the dimensions of cavities of the heart
timeFrame: 15 days
measure: haemodynamic study of the conditions
timeFrame: 15 days
measure: characterization of ambient sound military aero by Sound Level Meter
timeFrame: 15 days
measure: sensitivity analysis of noise dosimetry
timeFrame: 15 days
measure: subjective perception of noise
timeFrame: 15 days
measure: analysis of clinical background for selection of sample subjects
timeFrame: 3 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Politécnica de Madrid
Study officials:
affiliation: Universidad Politecnica de Madrid
name: Fredesvinda M Méndez, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Politecnica de Madrid
name: Manuel Recuero, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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
citation: 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.
citation: Rosenstock, L. Criteria for a recommended standard: occupational noise exposure. National Institute for Occupational Safety and Health. NIOSH, publication June 1998. 98-126.
citation: 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.
citation: 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.