Download - 10.5 Methodology 2
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8/13/2019 10.5 Methodology 2
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4.4 STUDY PERIOD
Preparatory Phase – ( 3 ) months
Data collection – ( 1 ) year and ( 6 ) months
Data analysis and report writing – ( 6 ) months
Year 2009 2010 2011
Month
c t o ! e r
" o # e m ! e r
D e c e m ! e r
$ a n % a r y
& e ! r % a r y
M a r c h
' p r i l
M a y
$ % n e
$ % l y
' % g % s t
( e p t e m ! e r
c t o ! e r
" o # e m ! e r
D e c e m ! e r
$ a n % a r y
& e ! r % a r y
M a r c h
' p r i l
M a y
$ % n e
$ % l y
Preparatory
Phase
Data
ollection
Data
'nalysis*
+eport
,riting
2-
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4.5 SAMPLE SIZE
Sample size = minimum 60
. /y %sing sample sie determination in health st%dies , ene#a 19914
&or 95 on7idence inter#al
n 8 2 p
d2
n 8 ( 1496 )2 ( 0465 ) ( 0435 ) * ( 041)2
8 6043
,here
n8 minim%m re%ired sample sie 7or 95 con7idence le#el
8 1496
p 8 pre#alence o7 cardiac a%tonomic ne%ropathy in
type 2 dia!etes mellit%s
8 6043
8 pre#alence o7 cardiac a%tonomic ne%ropathy in
type 2 dia!etes mellit%s
8 1.p 8 0435
D 8 margin o7 error 8 041
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4.6 MATERIALS AD MET!ODS
4.6." I#LUSIO #RITERIA
". 'll type 2 dia!etic patients who meet 'D' 2010 criteria
$. 'ge -0 year to :0 years
%. /oth se;es
4.6.$ ELUSIO #RITERIA
Patients with
". 'ny pre;isting heart diseases
$. P%lmonary disease
%. istory o7 recent (preceding two wee
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4.' RESEAR#! PRO#EDURE
• >ype 2 dia!etes mellit%s patients who 7%l7illed the incl%sion criteria were
recr%ited at dia!etic clinic clinic o7 "o (2) D (1000./edded) and "o (2)
M (500./edded)4
• 'mong them the patients who meet the e;cl%sion criteria (i4e4 patients not
s%ita!le 7or cardio#asc%lar response tests (7or e;ample – ischaemic heart disease
and myocardial in7arct) were r%led o%t 7rom this st%dy4
• 'ccording ?wing=s criteria 7ollowing 7i#e cardio#asc%lar a%tonomic 7%nction
tests will !e per7ormed as 7ollowing4 'nd the res%lts o7 these 7i#e tests will !e will
!e noted down and interpreted with ?wing=s classi7ication4
4.'." !ea() (a)e (esp*nse )* +eep ,(ea)-in / i.e ,ea) )* ,ea) a(ia)i*n 1R2R
a(ia)i*n3
>he patient lies %ietly and !reathes deeply at a rate o7 si; !reaths per min%te
(7i#e seconds in and 7i#e seconds o%t a rate that prod%ces ma;im%m #ariation in heart
rate ) while a heart monitor records the di77erence !etween the ma;im%m and minim%m
heart rates with a marhe ma;im%m and minim%m +.+ inter#als d%ring each !reathing cycle were meas%red
with @ernier caliper and con#ered to !eats*min the res%lts were then e;pressed as the
mean o7 the di77erence !etween ma;im%m and minim%m heart rate 7or the si; meas%red
cycles in !eats per min%te4
4.'.% !ea() (a)e (esp*nse )* s)an+in
>he patient is connected an electrocardiogram (?) monitor while lying down
and then stands to a 7%ll %pright position4 ? tracings are %sed to determine the 30A15
ratios calc%lated as the ratio o7 the longest +.+ inter#al ( 7o%nded at a!o%t !eat 30 ) to
the shortest +.+ inter#als may not always occ%r at e;actly the 15th or 30th !eats a7ter
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standing4 >he ma;im%m Bminim%m 30A15 ratio as the longest +.+ inter#al d%ring !eats
20.-0 di#ided !y the shortest +.+ inter#al d%ring !eats 5.254
4.'.4 !ea() (a)e (esp*nse )* alsala maneue(
>he test was per7ormed !y the patient !lowing into the mo%th piece connected to
the modi7ied sphygmomanometer and maintained it at a press%re o7 -0 mmg 7or 15
seconds while contin%o%s ? was !eing recorded in lead CC4 are was tahe
mane%#er was per7ormed three times with one min%te inter#al !etween4 >he @alsal#a
ratio is determined 7rom ? tracings !y calc%lating the ratio o7 the longest +.+ inter#al
a7ter the mane%#er (re7lecting the !radycardic response to !lood press%re o#ershoot) the
shortest +.+ inter#al d%ring or shortly a7ter the mane%#er (re7lecting tachycardia as a
res%lt o7 strain)4
4.'.5 Ss)*li ,l**+ p(essu(e (esp*nse )* s)an+in
>he systolic !lood press%re di77erences !etween the lying and standing were ta
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-44241 aemoglo!in '1E 6454 >he test sho%ld !e per7ormed in a
la!oratory %sing a method that is "P certi7ied and
standardied to the D> assay4F +
-44242 &asting Plasma l%cose E 126mg*dl (:40 mmol*l) 4&asting is
de7ined as no caloric intawo.ho%r plasma gl%coseE 200mg*dl(1141mmol*l) d%ring an
>>4 >he test sho%ld !e per7ormed as descri!ed !y the ,
%sing a gl%cose load containing the e%i#alent o7 :5g anhydro%s
gl%cose dissol#ed in water4 +
-4424- Cn a patient with classic symptoms o7 hyperglycemia or
hyperglycemic crisis a random plasma gl%coseE200 mg*dl (1141
mmol*l)4
Cn the a!sence o7 %ne%i#ocal hyperglycemia criteria 1.3 sho%ld !e con7irmed !y
repeat testing4
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4.7.$ Ta,le /"3 Ein>s (i)e(ia an+ in)e(p(e)a)i*n *? a(+i*asula( (e?le@es )es)s
*? au)*n*mi neu(*pa)- /Ein DB "C'%3
?#al%ation o7 the res%lts
>he res%lts were then categoried into 7o%r gro%ps4
14 "ormal (grade C)4
24 ?arly parasympathetic damage with the res%lts o7 one o7 the three tests o7
parasympathetic 7%nction a!normal (grade CC)4
34 De7ined parasympathetic damage with the res%lts o7 at least two o7 the tests o7
parasympathetic 7%nction a!normal (grade CCC)4
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"ormal /orderline a!normal
Tes) (e?le)in )-e a(+i*asula( ?un)i*n
@alsal#a ratioG1421
1411.1420 H1410
eart rate (+.+)inter#al #ariation
d%ring deep !reathing
(!eat*min)
G15 11.1- H10
Cmmediate response to
standing4 G140-
1401. 1403 H1400
Tes) (e?le)in smpa)-e)i ?un)i*n
/lood press%reresponse to standing
(mmg)
H10 11.29 G30
/lood press%reresponse s%stained
handgrip (mmg)
G16 11.15 H10
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-4 om!ined parasympathetic and sympathetic damage where in addition to
a!normal parasympathetic res%lt 7indings in one or !oth o7 the sympathetic tests
are a!normal (grade C@)4
>hese grading can !e categoried into three gro%p as (1) "ormal 7or grade C (2) ?arly
'" 7or grade CC and (3) De7ined '" 7or grade CCC and C@4
4.C Da)a Analsis
't the end o7 the st%dy data was calc%lated with P so7tware #ersion 1640 and
analyed with Pearson correlation coe77icient and > test whene#er appropriate4 P #al%e
I0405 were considered signi7icant4 >a!le and diagrams were %sed as necessary4
4."0. E)-ial *nsi+e(a)i*ns
Cn7ormed consent was o!tained 7rom all patients4
?thical clearance was re%ested 7rom the M Med c4 (Cnt4Med4) post grad%ate
!oard o7 st%dies De7ence er#ices Medical 'cademy4
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