Clinical Variations and Pain Assessment in Newborns Submitted to Intratracheal Aspiration With Open and Closed System

January 12, 2011 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 04024002
        • Universidade Federal de Sao Paulo
      • São Paulo, Brazil, 04024002
        • Federtal university of São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 hour to 4 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Closed System
Application of Tracheal aspiration closed system, controlled by the use of Open system to tracheal aspiraiton.
Device: Tracheal aspiration close system
use of closed system in comparision to open system to tracheal aspiration of nweborns, analyzing pain and climical variations associated.
Other Names:
  • aspiration system
  • suctioning system
  • tracheal suctioning system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain response to tracheal suction
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Investigators

  • Principal Investigator: Mavilde LG Pedreira, RN, PhD, Federal University of São Paulo
  • Study Chair: Jaqueline Cardoso, RN, Federal University of São Paulo
  • Study Chair: Ruth Guinsberg, MD, PhD, Federal University of São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

January 11, 2011

First Submitted That Met QC Criteria

January 12, 2011

First Posted (Estimate)

January 13, 2011

Study Record Updates

Last Update Posted (Estimate)

January 13, 2011

Last Update Submitted That Met QC Criteria

January 12, 2011

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1094/09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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