Werther Brunow de Carvalho, Paulo Sérgio Lucas da Silva, Chiu Seing Tsok Paulo, Marcelo Machado Cunio Fonseca, Luiz Antônio Belli
Comparison be twe e n the Comfort and Hartwig se dation scale s
in pe diatric patie nts unde rgoing me chanical lung ve ntilation
Pediatric Intensive Care Unit, Hospital do Servidor Público Municipal de São Paulo,
São Paulo, Brazil
INTRODUCTION
O ne o f the mo st impo rtant g o als in the treatment within pediatric intensive care units (PICUs) is the manag ement o f pain and distress in c hild re n re c e iving a rtific ia l ve ntila tio n. Co ntro lled studies have demo nstrated reduced mo rbidity and mo rtality rates in patients when adequate analg esia is pro vided.1 , 2 To maintain lo w levels o f stress, pain and fear, these patients require special attentio n fro m nursing staff and p a re nts, b ut a d d itio na l p ha rma c o lo g ic a l treatment is also necessary. Therefo re PICU staff ro utine ly a tte mp t to c o ntro l d istre ss b y administering sedatives and analg esics, and/ o r ma na g ing the so c ia l a nd p hy sic a l enviro nment. Ho wever, to determine the effect o f sedatio n, many sedatio n-sco re scales have been develo ped in o rder to reduce the subjective impressio ns, whic h lea d to wide individua l variatio n in evaluatio n amo ng the clinical staff. The Co mfo rt scale3 is based aro und eig ht b e ha vio ra l a nd p hysio lo g ic a l p a ra me te rs develo ped fro m literature reviews and surveys amo ng experienced PICU nurses. This empirical sc a le is a re lia b le a nd va lid me tho d fo r a sse ssing c hildre n’s distre ss a nd it is no n-intrusive , multid ime nsio na l, suita b le fo r
ABSTRACT
Contex t: A high number of hospitalizedchildren do not receive adequate sedation due to inadequate evaluation and use of such agents. W ith the increase in knowledge of sedation and analgesia in recent years, concern has also risen, such that it is now no t acceptable that incorrect evaluations of the state of children’s pain and anxiety are made.
O bjective: A co mpariso n between the Co mfo rt and Hartwig sedatio n scales in pediatric patients undergo ing mechanical lung ventilatio n.
Design: Pro spective co ho rt study.
Setting: A pediatric intensive care unit with three beds at an urban teaching ho spital.
Pa tients: Thirty simultaneous and independent observations were conducted by specialists on 1 8 patients studied.
Dia gnostic Test: Co mfo rt and Hartwig scales were applied, after 3 minutes o f o bservatio n.
M a in M ea surem ents: Agreement rate (kappa).
Results: O n the Comfort scale, the averages for adequately sedated, insufficiently sedated, and over-sedated were 2 0 .2 8 (SD 2 .7 8 ), 2 7 .5 (SD 0 .7 0 ), and 1 5 .1 (SD 1 .1 0 ), respectively, whereas on the Hartwig scale, the averages for adequately sedated, insufficiently sedated, and over-sedated were 1 6 .3 5 (SD 0 .7 7 ), 2 0 .8 5 (SD 1 .5 7 ), and 1 3 .0 (SD 0 .8 9 ), respectively. The observed agreement rate was 6 3 % (p = 0 .0 0 6 ) and the expected agreement rate was 4 4 % with a Kappa co efficient o f 0 .3 4 5 2 3 8 (z = 2 .4 9 ).
Conclusions: In o ur study there was no statistically significant difference whether the mo re co mplex Co mfo rt scale was applied (8 physio lo gical and behavio ral parameters) o r the less co mplex Hartwig scale (5
behavio ral parameters) was applied to assess the sedatio n o f mechanically ventilated pediatric patients.
Key -w ords: Sedatio n scale. Co mfo rt. Hartwig. Mechanical Lung Ventilatio n. Pediatric Intensive Care.
Figure 1 - The COMFORT scale3 - One point was given for the highest and 5 points for the lowest rate of sedation (range from 8 to 40 points). We considered sedation as excessive in the range 8 to 16, adequate (17 to 26) or insufficient (27 to 40).
co ntinuo us o b serva tio n, a nd it ma y include variables that remain variable in the face o f the co ntinuo usly cha ng ing sta te o f the pa tient’s disease.
The Ha rtwig sc a le4 is a le ss c o mple x sedatio n sco re based o n five behavio ral criteria. This is ano ther empirical scale develo ped fro m surveys amo ng experienced PICU nurses. It was devised to quantify the effect o f sedatio n during ro utine pro cedures such as tracheal aspiratio n and its validity and reliability in the clinical assessment o f the deg ree o f sedatio n in patient po pulatio ns has already been demo nstrated.
W e p e rfo rme d a p ro sp e c tive tria l co mparing these two sedatio n scales in pediatric patients underg o ing mechanical ventilatio n.
METHODS
Stud y p o p ula tio n. The stud y w a s co nducted during an 1 1 -mo nth perio d fro m March 1 9 9 5 to January 1 9 9 6 in the PICU at Ho spital do Servido r Público Municipal (HSPM) in São Paulo , Brazil. To evaluate ag reement b e tw e e n the se tw o se d a tio n sc a le s w e p e rfo rme d simulta ne o us a nd ind e p e nd e nt ra ting s c o nd uc te d b y sp e c ia list p e d ia tric intensive care physicians using the American Co mfo rt scale (Fig 1 ) and the Euro pean Hartwig scale (Fig 2 ) in pediatric patients underg o ing mechanical ventilatio n.
Inclusio n criteria. a) ag e < 1 8 years; b) me c ha nic a lly ve ntila te d p a tie nts re c e iving intermittent mandato ry ventilatio n o r co ntinuo us p o sitive a irw a y p re ssure ; c ) p a tie nts w ith endo tracheal intubatio n o r with a tracheo sto my in pla c e. Ea c h pa tient wa s seda ted b y the ma na g ing p hy sic ia n using o p ia te s, b e nz o d ia z e p ine s, b a rb itura te s, o r a co mbinatio n o f these medicatio ns. All patients had co ntinuo us cardio respirato ry mo nito ring , and blo o d pressure mo nito ring via an inserted arterial catheter.
Exc lusio n c rite ria . a ) he a d injury; b ) ischemic encephalo pathy; c) stro ke; d) mental dysfunctio n; e) multiple trauma within 7 2 ho urs o f the study; f) abno rmalities o f muscle functio n;
g ) neuro muscular blo ckag e; h) chro nic co ug h. The exclusio n criteria were selected to ensure that no rmal neuro lo g ic respo nses were being assessed, thus avo iding misunderstanding o f items assessed by these two sedatio n scales (suc h a s musc le to ne o r re sp o nse to the ventila to r), a nd to reduc e the likeliho o d o f distress due to unco ntro lled pain.
Data co llectio n and definitio ns. Each study c o nsisted o f a 3 -minute perio d o f intensive o bservatio n o f the patient in his o r her pediatric ICU bed. After each o bservatio n, evaluatio ns using Co mfo rt sco ring (rang ing fro m 8 to 4 0 ) and Hartwig sco ring (rang ing fro m 8 to 2 5 ) were do ne by the specialist. W e g raded the sedatio n g iven by Co mfo rt sco res as fo llo ws: adequate (1 7 to 2 6 po ints), excessive (8 to 1 6 po ints) and insufficient (2 7 to 4 0 po ints). Using the Hartwig sco res, the co rrespo nding sedatio n g ra de s we re : a de q ua te (1 5 to 1 8 po ints), excessive (8 to 1 4 po ints) and insufficient (1 9 to 2 5 po ints).
Sta tistic a l me tho d s. W e use d the a g re e me nt ra te (ka p p a ) w ith unitiz e d distrib utio n, a nd p < 0 .0 1 wa s c o nsidered sig nificant.5
RESULTS
This study co mprised 3 0 o bservatio ns in
1 8 mechanically ventilated pediatric patients ag ed 1 6 days to 5 years (mean: 1 6 .4 5 mo nths, SD 1 7 .2 7 ; see Table 1 ) and the reaso n fo r PICU a dmissio n we re : c a rdia c dise a se - 1 c a se (5 .5 %); neuro lo g ic disease - 1 case (5 .5 %); infectio us disease - 7 cases (3 9 %); respirato ry disease - 9 cases (5 0 %).
The analysis o f the deg ree o f sedatio n in o ur patients o btained by applying the Co mfo rt and Hartwig scales sho wed almo st the same results amo ng tho se with adequate sedatio n (Table 2 ).
O n the Co mfo rt scale, the mean sco res fo r adequate, insufficient and excessive sedatio n were: 2 0 .2 8 (SD 2 .7 8 ), 2 7 .5 (SD 0 .7 0 ), and 1 5 .1 (SD 1 .1 0 ), respectively. O n the Hartwig sc a le , the a ve ra g e sc o re s fo r a d e q ua te , insufficient and excessive sedatio n were: 1 6 .3 5 (SD 0 .7 7 ), 2 0 .8 5 (SD 1 .5 7 ), and 1 3 (SD 0 .8 9 ), respectively. The analysis o f agreement between Co mfo rt and Hartwig sco res is presented in the table 2 .
DISCUSSION
In re c e nt ye a rs the a d ministra tio n o f sedative and analg esic ag ents has been widely studied and such ag ents have been applied in the co ntro l o f stress in critically ill patients, especially children. Sedatio n and analgesia are kno wn to be po werful instruments pro viding c o mfo rt a nd re d uc ing c o mp lic a tio ns.6 The utilizatio n o f these drug s has been frequently based o n subjective perso nal evaluatio n witho ut a va lid o b jec tive metho d o f mea suring the distress.
Altho ug h a number o f reliable and valid
Ta ble 1 - Age of PICU pa tient a t the time of observa tion
Infants (newborn to 1 2 months) 1 (5 .5 %)
Toddler (from 1 3 to 2 3 months) 1 2 (6 6 .7 %)
Preschool (from 2 4 to7 1 months) 5 (2 7 .8 %)
Ta ble 2 - Qua lity of seda tinon a nd a na lysis of a greement betw een Comfort a nd Ha rtw ig scores
Comfort grade
Hartwig grade O ver-sedated Adequately sedated Insufficiently sedated Tota l
O ver-sedated 5 3 0 8 (2 6 .6 %)
Adequately sedated 5 12 0 1 7 (5 6 .7 %)
Insufficiently sedated 0 3 2 5 (1 6 .7 %)
tota l 1 0 (3 3 .4 %) 1 8 (6 0 .9 %) 2 (6 .6 %) 3 0 (1 0 0 %)
me tho d s ha ve b e e n d e ve lo p e d to p ro vid e o b se rve rs with a ra ting o f b e ha vio ra l a nd physio lo g ic a l indic es fo r c hildren’s distress during ho spitalizatio n in PICUs, these scales ha ve sp e c ific c ha ra c te ristic s tha t ma y b e questio ned. So me scales have been develo ped fro m the o bservatio n o f reactio ns during painful pro cedures.7 These scales appear inadequate fo r co ntinuo us o bservatio n because o f the stress fa c to r d uring the no c ic e p tive stimula tio n pro cedure. In additio n, o ther o bjective scales are inapplicable in pediatric intensive care units b e c a use the y do no t e va lua te ne o na ta l o r critically ill patients.8
In o rder to g et mo re experience in the applicatio n o f o bjective sedatio n scales and to try to validate a less co mplex scale with fewer variables, we made a co mpariso n between two distinct metho ds.
The Co mfo rt scale has previo usly been sho wn to be reliable and has been validated as a descripto r o f behavio ral and physio lo g ical d istre ss w ith g o o d re sults. Ho w e ve r, its applicatio n is no t easy because o f the g reat number o f variables (eight), thus rendering it no t very practical. In additio n to this, its applicability is questio nable when used in a ro utine manner. The Ha rtw ig sc a le me a sure s o nly b eha vio ra l va ria b les, a nd therefo re ha s a n advantag e because o f its facility o f applicatio n. The ne e d fo r e nd o tra c he a l a sp ira tio n is q ue stio na b le due to the pa infulne ss o f this pro cedure, thus affecting the g o al o f o ur study o n sedatio n. N evertheless, this fact is minimized as it is a ro utine pro cedure do ne in artificially ventilated patients. Bo th scales were desig ned to be ag e-independent and used at any time to assess the adequacy o f sedatio n at that po int in time. Fo r this reaso n repeated o bservatio ns o f the same patient were no t excluded.
W e no ted that there was a lo w standard desviatio n fo r the means co nsidered fo r the degrees o f sedatio n o n bo th sedatio n scales. W hen the results were analyzed, the agreement rate o bserved was 6 3 %, and it was statistically sig nificant because there was little difference
between the sco res in spite o f the fact that we had a lo w n in o ur sample.
CONCLUSION
There was no statistical difference when the Co mfo rt and Hartwig scales were applied in mechanically ventilated children, therefo re allo wing their use in daily clinical practice.
REFERENCES
1. Anand KJS, Hansen DD, Hickey PR. Ho rmo nal-metabo lic stress respo nses in neo nates undergo ing cardiac surgery. Anesthesio lo gy 1990;73:661-70.
2. Anand KJS, Hickey PR. Halo thane-mo rphine co mpared with high-do se sulfentanyl fo r anesthesia and po sto perative analgesia in neo natal cardiac surgery. N Engl J Med 1992;326:1-9.
3. Ambuel B, Hamlett KW, Marx CM, et al. Assessing distress in pediatric intensive care enviro nments: the COMFORT scale. J Pediatric Psycho 1992;17:95-109.
4. Hartwig S, Ro th B, Theiso n M. Clinical experience with co ntinuo us intraveno us sedatio n using midazo lam and fentanyl in the pediatric intensive care unit. Eur J Pediatric 1991;150:784-8.
5. Marx CM, Sm ith PG, Lo wrie LH, e t al. Op tim al se d atio n o f mechanically ventilated pediatric critical care patients. Crit Care Med 1994;22:163-70.
6. Fleiss JL. Statistical metho ds fo r rates and pro po rtio ns. 2nd ed. Jo hn Wiley & So ns; 1981:212-25.
7. Jay SM, Ozo lins M, Ellio t CH. Behavio ral management o f children’s distress during painful pro cedures. Behav Res Ther; 1985;23(5):513-20. 8. McGrath PJ, Jo hnso n G, Go o dman JT, et al. CHEOPS: a behavio ral scale fo r rating po sto perative pain in children. In: HL Fields, et al. edito rs. Advances in pain research and therapy. Vo l. 9, 1985;305-402.
Ack now ledgm ents: Dr. Ediso n Cunha fo r the help g iven in the review o f the article.
W erther Brunow de Ca rva lho - Pro fesso r and Directo r o f the Pediatric Intensive Care Unit, Pediatric Department, Universidade Federal de São Paulo / Esco la Paulista de Medicina.
Pa ulo Sér gio Luca s da Silva - Assistant Physicians, Pediatric Intensive Care Unit o f Ho spital do Servido r Público Municipal de São Paulo .
Chiu Seing Tsok Pa ulo - Assistant Physicians, Pediatric Intensive Care Unit o f Ho spital do Servido r Público Municipal de São Paulo .
M a rcelo M a cha do Cunio Fonseca - Assistant Physicians, Pediatric Intensive Care Unit, Pediatric Department, Universidade Federal de São Paulo / Esco la Paulista de Medicina.
RESUMO
Contex to: É elevado o número de crianças ho spitalizadasque não recebem uma sedação adequada, devido a avaliação e ao uso inadequado desses agentes. No s último s ano s aumento u a preo cupação e o s co nhecimento s a respeito da sedação e analgesia, de tal mo do que é inaceitável ho je em dia termo s uma criança sem co rreta avaliação de seu estado de do r e ansiedade. O bjetivo: Co mparar o uso de duas escalas de sedação (CO MFO RT e HARTW IG ) em pacientes pediátrico s em ventilação pulmo nar mecânica. Tipo de estudo: Estudo pro spectivo . Loca l: Unidade de cuidado s intensivo s pediátrico s de ho spital terciário . Pa rticipa ntes: Realizadas 3 0 o bservaçõ es, simultâneas e independentes, em 1 8 pacientes, po r médico s especializado s. Teste dia gnóstico: Apó s o bservação de três minuto s, aplico u-se critério s o bjetivo s (escalas de CO MFO RT e HARTW IG ) para avaliar a sedação . Va riá vel estuda da : Taxa de co nco rdância (Co eficiente Kappa) o nde p < 0 ,0 1 fo i co nsiderado significante. Resulta dos: Escala CO MFO RT (média e desvio padrão ) para adequadamente sedado ,
inadequadamente sedado e muito sedado fo i 2 0 ,2 8 ± 2 ,7 8 , 2 7 ,5 ± 0 ,7 0 e 1 5 ,1 ± 1 ,1 0 respectivamente. Para a escala de HARTW IG : 1 6 ,3 5 ± 0 ,7 7 , 2 0 ,8 5 ± 1 ,5 7 e 1 3 ,0 ± 0 ,8 9 . Taxa de co nco rdância o bservada 6 3 % (p = 0 ,0 0 6 ), esperada de 4 4 % co m o co eficiente kappa = 0 ,3 4 5 2 3 8 (z = 2 ,4 9 ). Conclusões: Em no sso estudo , não ho uve diferença significativa na aplicabilidade entre as escalas de CO MFO RT e HARTW IG em assegurar o nível de sedação em crianças submetidas a ventilação pulmo nar mecânica.
Pa la vra s-cha ve: Escala de sedação . Co nfo rt. Hartwig. Ventilação pulmo nar mecânica. Cuidado s intensivo s pediátrico s.
Sourcesof funding: N o t declared
Conflict of interest: N o t declared
La st received: 1 2 February 1 9 9 9
Accepted: 3 0 April 1 9 9 9
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