Patient-ventilator Asynchrony During Mechanical Invasive Assisted-ventilation in Pediatric Patients (NavPed-Inv)
The purpose of this study is to document the prevalence and type of asynchronies incidence during invasive mechanical ventilation in pediatric patients breathing under pressure support.
And to observe the impact of adjusting the expiratory trigger setting on asynchronies, and compare these incidences with asynchronies measured in pediatric patient breathing under NAVA system (Neurally Adjusted Ventilatory Assist).
연구 개요
상세 설명
Two sessions will be recorded, one in PSV, one with NAVA, delivered in a random order after being sure the infant is calm and comfortable, according to his parents and/or the nurse in charge.
Criteria for initiating invasive ventilation and to start PSV will follow the usual practice guidelines of the unit.
Ventilation parameters in PS will be adjusted by the clinician in charge of the patient, as usual based on clinical observation. Investigators will not interfere with ventilator settings. Ventilation will be applied via an endotracheal tube, uncuffed for the majority (if infant < 5 years), according to commonly applied guidelines in this unit.
One 15 minutes session will be recorded, after being sure the infant is calm and comfortable according to the parents and/or the nurse in charge. Then the clinician in charge of the patient will modify the ETS, first decreasing it of 10% below the initial set value, and will be recorded the following 5 minutes after stabilization and secondly increasing it of 10% above the initial set value, and will be recorded the following 5 minutes after stabilization.
NAVA will be set to deliver initially the same peak pressure (comparable level of assist) than during the initial PS period. Same PEEP will be delivered in both modes. This is possible with a pre-visualization window, allowing adjustments before switching to the NAVA mode. Nava ventilation will be recorded during 20 minutes.
The 2 sessions, Pressure support and Nava, will be recorded consecutively.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Laurence Vignaux
- 전화번호: 0041223727448
- 이메일: laurence.vignaux@hcuge.ch
연구 연락처 백업
- 이름: Peter Rimensberger
- 전화번호: Tél: + 41-22 37 24 730
- 이메일: peter.rimensberger@hcuge.ch
연구 장소
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Geneva, 스위스, 1211
- 모병
- University Hospital of Geneva
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연락하다:
- Laurence Vignaux
- 전화번호: 0041223727448
- 이메일: laurence.vignaux@hcuge.ch
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연락하다:
- Peter Rimenberger
- 전화번호: 00412237 24 730
- 이메일: peter.rimensberger@hcuge.ch
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수석 연구원:
- Peter Rimensberger, MD
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부수사관:
- Laurence Vignaux
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부수사관:
- Thomas Jaecklin, MD
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부수사관:
- Serge Grazioli, MD
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부수사관:
- Lise Piquilloud
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부수사관:
- Philippe Jolliet, Pr
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부수사관:
- Didier Tassaux, MD
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- all consecutive patients from 4 weeks to 12 years (post natal interm infants) admitted to the pediatric intensive care unit (PICU) and receiving mechanical ventilation in pressure support ventilation
Exclusion Criteria:
- Non treated pneumothorax
- Hemodynamic instability
- At least 2 hours following the admission in the PICU in post cardiac surgery
- FiO2 > 0.6
- Poor short term prognosis (defined as a high risk of death in the next seven days)
- contraindication for gastric tube or obtention of a reliable EMGdi signal
- Known esophageal problem (hiatal hernia, esophageal varicosities)
- Active upper gastro-intestinal bleeding or any other contraindication to the insertion of a naso-gastric tube
- Neuromuscular disease
- Patients with a pacemaker
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Pressure support
in this arm, pressure support will be recorded under 3 conditions:
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Ventilation under pressure support
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실험적: NAVA
Neurally Adjusted ventilatory Assist is a ventilation mode where the ventilator is piloted by the electrical activity of the diaphragm Ventilation is triggered and cycled off by the electrical activity of the diaphragm, the pressure delivered being proportional to this activity.
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Ventilation under NAVA
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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asynchronies
기간: 12 months
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Asynchronies during mechanical ventilation are the following: Auto triggering, double triggering, late cycling, premature cycling and ineffective effort. all ventilatory parameters are recorded under Pressure support (3 phases: 3 levels of expiratory trigger setting, initial, +10% and -10%, 15 min, 5 min and 5 min respectively) and NAVA (1 phase, 20 min). Asynchronies will be determined by measuring each ventilatory cycle of all recordings. |
12 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Peter Rimensberger, MD, University Hospital of Geneva
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
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
기타 연구 ID 번호
- HUG-matped 09-253
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. .
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