- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01276873
Clinical Variations and Pain Assessment in Newborns Submitted to Intratracheal Aspiration With Open and Closed System
2011년 1월 12일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
13
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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São Paulo, 브라질, 04024002
- Universidade Federal de Sao Paulo
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São Paulo, 브라질, 04024002
- Federtal university of São Paulo
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
1시간 (어린이)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pain response to tracheal suction
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Mavilde LG Pedreira, RN, PhD, Federal University of São Paulo
- 연구 의자: Jaqueline Cardoso, RN, Federal University of São Paulo
- 연구 의자: Ruth Guinsberg, MD, PhD, Federal University of São Paulo
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2010년 1월 1일
기본 완료 (실제)
2010년 7월 1일
연구 완료 (실제)
2010년 7월 1일
연구 등록 날짜
최초 제출
2011년 1월 11일
QC 기준을 충족하는 최초 제출
2011년 1월 12일
처음 게시됨 (추정)
2011년 1월 13일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2011년 1월 13일
QC 기준을 충족하는 마지막 업데이트 제출
2011년 1월 12일
마지막으로 확인됨
2010년 12월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 1094/09
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .