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- Klinische proef NCT01276873
Clinical Variations and Pain Assessment in Newborns Submitted to Intratracheal Aspiration With Open and Closed System
12 januari 2011 bijgewerkt door: Federal University of São Paulo
Clinical Variations and Pain Assessment in Newborns Submitted to Intratracheal Aspiration With Open and Closed System.
To compare clinical effects identified in infants undergoing intratracheal aspiration with open and closed systems and verify the presence and intensity of pain in newborns during intratracheal suction, according to the system applied.Clinical, randomized, controlled, and crossover study, performed at two neonatal intensive care units after approval by the ethics committee.
The sample consisted of infants from zero to seven days of age, 26 weeks of gestational age, and the exclusion criteria were use of mechanical ventilation with high-frequency oscillatory, in use of inhaled nitric oxide, in the acute phase of circulatory failure, central nervous system disorders, without reactivity to stimulus, severe asphyxia, Apgar score less than three in the fifth minute, as well as, presence of chromosomal abnormalities and congenital malformations.
After obtaining the informed consent from the responsible, children were randomly allocated into the experimental (CS) and control (OS) groups.
The dependent variables of this study respiratory rate (RR), peripheral oxygen saturation (SatpO2), heart rate (HR), blood pressure (BP) and pain, as well as, of the complementary variables, were collected through observation, the Premature Infant Pain Profile (PIPP) scale application and medical records consultation.
During the data collection the period of variables observation were: T1 (immediately before suctioning), T2 (during suctioning), T3 (immediately after) and T4 (10 minutes after).
To the statistical analysis were applied Fisher exact test, McNemar, Binomial, Student t test, Wilcoxon and Mann Whitney, settling at 0.05 level of significance.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Background: Patients who underwent tracheal intubation require intratracheal tube secretions sucking, and open system (OS) or closed system (CS) can be used, in order to preserve the tracheal tube permeability and an adequate ventilation and blood oxygenation.
Respiratory and hemodynamic complications, as well as, presence of pain can be possibly experienced in newborns submitted to such procedure.
Objectives: To compare clinical effects identified in infants undergoing intratracheal aspiration with OS or CS and verify the presence and intensity of pain in newborns during intratracheal suction, according to the system applied.
Methods: Clinical, randomized, controlled, and crossover study, performed at two neonatal intensive care units after approval by the ethics committee.
The sample consisted of infants from zero to seven days of age, 26 weeks of gestational age, and the exclusion criteria were use of mechanical ventilation with high-frequency oscillatory, in use of inhaled nitric oxide, in the acute phase of circulatory failure, central nervous system disorders, without reactivity to stimulus, severe asphyxia, Apgar score less than three in the fifth minute, as well as, presence of chromosomal abnormalities and congenital malformations.
After obtaining the informed consent from the responsible, children were randomly allocated into the experimental (CS) and control (OS) gruops.
The dependent variables of this study respiratory rate (RR), peripheral oxygen saturation (SatpO2), heart rate (HR), blood pressure (BP) and pain, as well as, of the complementary variables, were collected through observation, the Premature Infant Pain Profile (PIPP) scale application and medical records consultation.
During the data collection the period of variables observation were: T1 (immediately before suctioning), T2 (during suctioning), T3 (immediately after) and T4 (10 minutes after).
To the statistical analysis were applied Fisher exact test, McNemar, Binomial, Student t test, Wilcoxon and Mann Whitney, settling at 0.05 level of significance.
Results: The studied groups did not show significant differences concerning the complementary variables.
There were no statistically significant influences regarding the use of OS and CS of intratracheal suction in any of the dependent variables studied.
Clinical consequences were observed with the use of both systems.
It was demonstrated that immediately after intratracheal aspiration, the newborns had higher RR average in OS (58,4±9,6) group when compared to CS (56,2±5,9).
Average values of SatpO2 were lower in OS (90,5±4,8) group compared to CS (91,6±4,6).
Bradycardia was not verified in any group, however, there was a trend toward higher mean values of HR immediately after intratracheal aspiration, especially with OS (149,5±17,4) compared with the values identified before the procedure (143,2±18,1).
There was low variation in the mean BP value in the two groups during the period of assessment, using both techniques.
Regarding pain it was found that, with OS the average score was 7,9±4,4 and 6,5±3,8 with CS, demonstrating presence of mild to moderate pain.
During the use of OS intratracheal aspiration higher pain scores (p=0,038) where verified in newborn females compared to males, this result was not observed when using CS.
Conclusion: There was no statistically significant difference regarding the clinical implications, the presence and intensity of pain observed in ventilated newborns, according to the use of OS or CS to intratracheal aspiration.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
13
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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São Paulo, Brazilië, 04024002
- Universidade Federal de Sao Paulo
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São Paulo, Brazilië, 04024002
- Federtal university of São Paulo
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
1 uur tot 4 weken (Kind)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- infants from zero to seven days of age.
- 26 weeks of gestational age.
- responsible concordance in participation
Exclusion Criteria:
- use of mechanical ventilation with high-frequency oscillatory.
- use of inhaled nitric oxide.
- acute phase of circulatory failure.
- central nervous system disorders.
- without reactivity to stimulus.
- severe asphyxia.
- Apgar score less than three in the fifth minute.
- Presence of chromosomal abnormalities and congenital malformations
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Closed System
Application of Tracheal aspiration closed system, controlled by the use of Open system to tracheal aspiraiton.
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use of closed system in comparision to open system to tracheal aspiration of nweborns, analyzing pain and climical variations associated.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Pain response to tracheal suction
Tijdsspanne: 48 hours
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There were no statistically significant influences regarding the use of open (OS) or close system (CS) to intratracheal suction in this dependent variable.
With OS the average score was 7,9±4,4 and 6,5±3,8 with CS, demonstrating presence of mild to moderate pain.
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48 hours
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Mavilde LG Pedreira, RN, PhD, Federal University of São Paulo
- Studie stoel: Jaqueline Cardoso, RN, Federal University of São Paulo
- Studie stoel: Ruth Guinsberg, MD, PhD, Federal University of São Paulo
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 januari 2010
Primaire voltooiing (Werkelijk)
1 juli 2010
Studie voltooiing (Werkelijk)
1 juli 2010
Studieregistratiedata
Eerst ingediend
11 januari 2011
Eerst ingediend dat voldeed aan de QC-criteria
12 januari 2011
Eerst geplaatst (Schatting)
13 januari 2011
Updates van studierecords
Laatste update geplaatst (Schatting)
13 januari 2011
Laatste update ingediend die voldeed aan QC-criteria
12 januari 2011
Laatst geverifieerd
1 december 2010
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- 1094/09
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