- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01276873
Clinical Variations and Pain Assessment in Newborns Submitted to Intratracheal Aspiration With Open and Closed System
12. januar 2011 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
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
Intervensjonell
Registrering (Faktiske)
13
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
São Paulo, Brasil, 04024002
- Universidade Federal de Sao Paulo
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São Paulo, Brasil, 04024002
- Federtal university of São Paulo
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
1 time til 4 uker (Barn)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain response to tracheal suction
Tidsramme: 48 hours
|
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.
|
48 hours
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Mavilde LG Pedreira, RN, PhD, Federal University of São Paulo
- Studiestol: Jaqueline Cardoso, RN, Federal University of São Paulo
- Studiestol: Ruth Guinsberg, MD, PhD, Federal University of São Paulo
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2010
Primær fullføring (Faktiske)
1. juli 2010
Studiet fullført (Faktiske)
1. juli 2010
Datoer for studieregistrering
Først innsendt
11. januar 2011
Først innsendt som oppfylte QC-kriteriene
12. januar 2011
Først lagt ut (Anslag)
13. januar 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
13. januar 2011
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. januar 2011
Sist bekreftet
1. desember 2010
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 1094/09
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