- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00702169
Continuous Monitoring of the Lungs Ventilation Dynamics During Mechanical Ventilation
Continuous Monitoring of the Lungs Ventilation Dynamics During Mechanical Ventilation by Small Surface Patches That Include Safe Motion Sensors
Background: Patients that suffer from respiratory failure and need mechanical ventilation are at risk of further deterioration due to complications induced by progression of lung disease or the mechanical ventilation. The complications usually develop in a progressive manner, but are currently detected relatively late, when there is already severe and life threatening deterioration in patient oxygenation and sometimes irreversible damages.
Objective:To measure chest wall dynamics, derived from sensors placed on the chest and abdomen.
Methods: The system comprises of patches attached to the chest wall and upper abdomen that include mechanical sensors that measure the mechanics of lung inflation and deflation.
연구 개요
상태
정황
상세 설명
Patients that suffer from respiratory failure and need mechanical ventilation are at risk of further life threatening deterioration following the development of mechanical problems related to airway management, development of lung barotrauma or displacement of the endotracheal tube.
Neonates especially need tight and sensitive monitoring of lung ventilation, because of the high prevalence of lung disease and need for ventilatory support in this population.
Methods:
The system comprises of patches attached to the chest wall and to the epigastrium. The patches include sensors that measure the mechanics of the lung inflation and deflation.
Study protocol
Following parental informed consent, three patches will be placed on both sides of the chest and over the epigastric area in infants that require tight respiratory monitoring.
The patches will be placed just beside the ECG patches. The placement of the patches will be performed by a physician. The monitoring can be preformed as long as the baby needs a tight respiratory monitoring. The patches will be replaced according to routine replacement policy of patches in the neonatal intensive care units, and at the regular time defined by the attending staff, and no longer than 24 hours. At the end of the data acquisition, the patches will be removed.
No additional intervention is required. The patient will be inspected by the supervising physician involve in the research.
It will not provide any data that may alter the treatment and will not interfere or influence the other monitoring devices that are used to evaluate the clinical status of the patient.
The other parameters that are regularly monitored, that are displayed on the bedside monitor and respirator will be recorded by the research assistant. The ventilated baby will be identified by a study number. There will be a separate database for the measurements and the demographic and clinical data. There will be no disclosure of the patient's identity along with the data analysis and publication of the results or communication to authorities or other medical practitioners.
Equipment safety:
The system is safe for the use in human subjects. The whole system is approved for safety according to the acquired standard ICE-60601
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Haifa, 이스라엘, 32985
- Department of Neonatology, Carmel Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Babies receiving respiratory support
Exclusion Criteria:
- Parental refusal to be included in the study
- Premature babies under 700 grams birth weight
- Prematurity below 26 weeks gestation
- Severe edematous babies (Hydrops fetalis)
- Severe Hypoxic Ischemic Encephalopathy, initial brain injury or severe intracranial bleeding or major congenital anomalies
- Skin reactions to the adhesive patches
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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1
Premature and term newborn infants (male/female)
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
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A data-bank of measured changes in lung dynamics at various clinical settings acquired by the chest sensors.
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2차 결과 측정
결과 측정 |
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Detection of changes in lung ventilation by the novel system. Feasibility study. Comparison of the detection made by the novel system to the conventional monitoring methods in use.
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공동 작업자 및 조사자
수사관
- 수석 연구원: Dan Waisman, MD, Department of Neonatology Carmel Medical Center
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 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
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