Ignite Creation Date:
2024-05-05 @ 11:10 PM
Last Modification Date:
2024-10-26 @ 10:30 AM
Study NCT ID:
NCT01276873
Status:
COMPLETED
Last Update Posted:
2011-01-13
First Post:
2011-01-11
Brief Title:
Clinical Variations and Pain Assessment in Newborns Submitted to Intratracheal Aspiration With Open and Closed System
Sponsor:
Federal University of São Paulo
Organization:
Federal University of São Paulo
Study Overview
Official Title:
Clinical Variations and Pain Assessment in Newborns Submitted to Intratracheal Aspiration With Open and Closed System
Status:
COMPLETED
Status Verified Date:
2010-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 appliedClinical 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 005 level of significance
Detailed Description:
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 005 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 58496 group when compared to CS 56259 Average values of SatpO2 were lower in OS 90548 group compared to CS 91646 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 1495174 compared with the values identified before the procedure 1432181 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 7944 and 6538 with CS demonstrating presence of mild to moderate pain During the use of OS intratracheal aspiration higher pain scores p0038 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None