Clinical Variations and Pain Assessment in Newborns Submitted to Intratracheal Aspiration With Open and Closed System
Condition: Adverse Reaction to Systemic Agents
Study type: Interventional

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 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.
    

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 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.
    

Intervention name(s): Tracheal aspiration close system
Intervention type(s): Device
Intervention description(s): use of closed system in comparision to open system to tracheal aspiration of nweborns, analyzing pain and climical variations associated.
Other intervention name(s): aspiration system; suctioning system; tracheal suctioning system
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Artificial Respiration; Suction; Pain; Nursing; Neonatology