- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02403791
Point-of-Care Bedside Lung Ultrasound Examination Advanced Trial Protocol (PoCBLUEPlus)
A Prospective, Multi-center, Open-label and Double-blind, Standard-controlled, Non-inferiority, Diagnostic Study of Lung Ultrasound for Management of Mechanical Ventilation in Neonatal Acute Respiratory Distress Syndrome
연구 개요
상세 설명
Neonatal acute respiratory distress syndrome (ARDS) is a critical condition requiring dynamic evaluation and interventions. Point-of-care bedside lung ultrasound examination (PoC-BLUE) is a noninvasive, readily available imaging modality that can complement physical and clinical evaluation.
At any time, most neonates and infants with ARDS in medical intensive care units (ICUs) require mechanical ventilation, making it one of the most frequently used critical care technologies. However, difficulties with regard to the accurate diagnosis of ARDS before administration of mechanical ventilation, dynamic monitoring of treatment effects during administration of mechanical ventilation, and decision-making of timing in weaning from mechanical ventilation, are often encountered in the majority neonates and infants who require mechanical ventilation.
Hence, techniques that expedite and advance the knowledge of the administration of mechanical ventilation should have an important clinical significance in the diagnosis, treatment and prognosis of ARDS.
Preliminary researches have suggested that BLUE has a high diagnostic accuracy in patients with acute respiratory failure, and has the potential to quantify the rate and degree of diaphragm thinning during mechanical ventilation, which may be useful to predict extubation success or failure during either spontaneous breathing (SB) or pressure support (PS) trials.
Unfortunately, few studies focus on the availability of PoC-BLUE in management of mechanical ventilation in neonatal acute respiratory distress syndrome. Also, they call into question the possible association of the demographic and clinical confounders with the diagnostic accuracy of PoC-BLUE for diagnosis, monitoring and prognosis of ARDS in the whole process of mechanical ventilation.
Given that a considerable need for a timely and dynamic diagnosis of severe condition and therapy evaluation during mechanical ventilation has been triggered to integrate the currently available bulk of knowledge and information, the objective of this study is to investigate the availability and diagnostic accuracy of PoC-BLUE Plus protocol in management of mechanical ventilation in ARDS.
연구 유형
등록 (실제)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- All infants who present to the ICU with respiratory symptoms suspicious for ARDS, according to Pediatric Acute Respiratory Distress Syndrome: Consensus Recommendations From the Pediatric Acute Lung Injury Consensus Conference, which is proposed by The Pediatric Acute Lung Injury Consensus Conference Group.
- In whom the treating Collaborative Review Groups of Poc-BLUE-Plus protocol believe would benefit from diagnostic imaging.
Exclusion Criteria:
- Infants who arrive at the ICU with a previously performed chest radiography
- Unstable infants with life-threatening injuries who require ongoing resuscitation
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Lung Ultrasound
In infants allocated to this arm Lung ultrasound for detection of ARDS will be performed before chest radiography.
|
Lung ultrasound evaluation is performed after clinical assessment and before chest radiography
다른 이름들:
|
|
활성 비교기: Chest Radiography
In infants allocated to this arm chest radiography will be performed for the detection of indirect signs of ARDS without ultrasound evaluation.
|
Chest Radiography is performed after clinical evaluation without using ultrasound assessment.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Accuracy of Lung Ultrasound in Neonatal ARDS
기간: Accuracy will be measured at the end of clinical evaluation in the ICU, an expected average of 4 days
|
Accuracy of lung ultrasound and chest radiography will be measured using as gold standard the independent evaluation of the entire medical records by two expert emergency physicians blinded to the lung ultrasound results and radiographic reports (digitalized chest radiography images will be available).
|
Accuracy will be measured at the end of clinical evaluation in the ICU, an expected average of 4 days
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Accuracy of Lung Ultrasound in the Ventilator-Associated Pneumonia
기간: Accuracy will be measured at the end of clinical evaluation in the ICU, an expected average of 4 days
|
Accuracy of lung ultrasound and chest radiography will be measured using as gold standard the independent evaluation of the entire medical records by two expert emergency physicians blinded to the lung ultrasound results and radiographic reports (digitalized chest radiography images will be available).
|
Accuracy will be measured at the end of clinical evaluation in the ICU, an expected average of 4 days
|
|
Accuracy of Lung Ultrasound in the Weaning of Ventilatory Support
기간: Accuracy will be measured at the end of clinical evaluation in the ICU, an expected average of 4 days
|
Accuracy of lung ultrasound and chest radiography will be measured using as gold standard the independent evaluation of the entire medical records by two expert emergency physicians blinded to the lung ultrasound results and radiographic reports (digitalized chest radiography images will be available).
|
Accuracy will be measured at the end of clinical evaluation in the ICU, an expected average of 4 days
|
공동 작업자 및 조사자
협력자
수사관
- 연구 책임자: Jie Zhou, MD, The First Affiliated Hospital with Nanjing Medical University
간행물 및 유용한 링크
일반 간행물
- Pediatric Acute Lung Injury Consensus Conference Group. Pediatric acute respiratory distress syndrome: consensus recommendations from the Pediatric Acute Lung Injury Consensus Conference. Pediatr Crit Care Med. 2015 Jun;16(5):428-39. doi: 10.1097/PCC.0000000000000350.
- Muscedere J, Dodek P, Keenan S, Fowler R, Cook D, Heyland D; VAP Guidelines Committee and the Canadian Critical Care Trials Group. Comprehensive evidence-based clinical practice guidelines for ventilator-associated pneumonia: diagnosis and treatment. J Crit Care. 2008 Mar;23(1):138-47. doi: 10.1016/j.jcrc.2007.12.008.
- ARDS Definition Task Force, Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.
- MacIntyre NR, Cook DJ, Ely EW Jr, Epstein SK, Fink JB, Heffner JE, Hess D, Hubmayer RD, Scheinhorn DJ; American College of Chest Physicians; American Association for Respiratory Care; American College of Critical Care Medicine. Evidence-based guidelines for weaning and discontinuing ventilatory support: a collective task force facilitated by the American College of Chest Physicians; the American Association for Respiratory Care; and the American College of Critical Care Medicine. Chest. 2001 Dec;120(6 Suppl):375S-95S. doi: 10.1378/chest.120.6_suppl.375s. No abstract available.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- PoC-BLUE-Plus One
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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. .
Linear Ultrasonic Sounder에 대한 임상 시험
-
University of WashingtonNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Indiana University 그리고 다른 협력자들모병
-
University of Texas Southwestern Medical Center모병경피증, 국소화 | 모르피아 | Frontal Linear Scleroderma en Coup de Sabre | 경피증, 폐쇄 | 경피증, 선형미국
-
Petrov, Andrey종료됨건강한 자원봉사자 | 약물 전달 시스템 | 액체 공기 흡입 | 관리 현장 부상스위스