- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01501643
Non Invasive Positive Pressure Ventilation for Prevention of Acute Chest Syndrome in Sickle Cell Disease (VPACS)
Non Invasive Positive Pressure Ventilation for Prevention of Acute Chest Syndrome in Sickle Cell Disease With Vaso-occlusive Crisis and Morphinic Treatment
Acute chest syndrome is a severe respiratory complication of sickle cell disease.
The standard prevention of this dangerous complication is spirometry in wich patient is required to take deep breaths trough a little device several times a day. This treatment is compromised when pain in important or when the patient is asleep and cannot participate.
The investigators hypothesised that non invasive ventilation in wich patient have no effort to take might be a better prevention than spirometry and may improve pain and quality of sleep.
Children with vaso-occlusive crisis necessitating morphinic treatment will be randomly assigned with either spirometry or ventilation and the investigators will monitor for occurrence of acute chest syndrome, pain and quality of sleep.
연구 개요
상태
상세 설명
Acute chest syndrome is a severe complication of sickle cell disease. Several factors can contribute to this complication including infections, vaso-occlusive crisis, important pain that may give shortness of breath and morphinic treatments as they may cause hypoventilation.
The standard prevention of this dangerous complication is incentive spirometry in wich patient is required to take deep breaths trough a little device several times a day. This treatment is compromised when pain in important or when the patient is asleep and cannot participate.
In patients who have had surgery who have also pain and morphinic treatments, non invasive ventilation have proven a good option for preventing pulmonary complications.
Besides, our experience in non invasive ventilation for treatment of acute chest syndrome show a good tolerance and efficiency. It also seems to help with pain management.
The investigators hypothesised that non invasive ventilation in wich patient have no effort to take might be a better prevention than incentive spirometry and may improve pain and quality of sleep.
After informed consent, patients aged from 6 to 20 years old with SS or S-Beta sickle cell disease with vaso-occlusive crisis necessitating morphinic treatment hospitalised in intensive care unit in Necker Hospital for Sick Children (Paris) will be randomly assigned with either spirometry or ventilation. It is a monocentric study.
Patients with acute chest syndrome, oxygen needs, pneumonia or other condition requiring ventilation at presentation will not be included.
Spirometry will be realised through volumetric devices, every two hours during the day with 10 maximum inspirations and at night if the patient is awake.
Non invasive ventilation will be applied through a nasal mask with VS III machines from Resmed®, at least one hour every four hour but may be maintained more if the patient chooses to or is asleep with the machine on.
The investigators will monitor for occurrence of acute chest syndrome, pain, morphinic requirements, length of hospital stay, comfort, quality of sleep The treatment will be continued until morphinic treatment is stopped. The investigators intend to include 60 patients in each arm to show a difference of 25% in the occurrence of acute chest syndrome (primary judgement criteria).
Acute chest syndrome will be defined according to the criteria used by Vichinsky (Vichinsky, E. P. et al. Acute chest syndrome in sickle cell disease: clinical presentation and course. Cooperative Study of Sickle Cell Disease. Blood 89, 1787-1792 (1997) The investigators will aslo compare morphinic requirements, length of hospital stay and quality of sleep as secondary judgment criteria.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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-
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Paris, 프랑스, 75015
- Hôpital Necker - Enfants Malades Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patient with SS or S-Beta sickle cell disease aged more than 6 years old and less then 20 years old
- Hospitalised since less then 24 hours for severe vaso-occlusive crisis (either peripheric localisation or thoracic crisis) with morphinic requirements according to local pain management protocol
- With a signed informed consent from the patient or his legal representative if the patient is under 18 years old
- Benefiting of the French social security system
Exclusion Criteria:
- Patient that has already participated in the study
- Oxygen requirements, pneumonia, acute chest syndrome or other condition necessitating non invasive ventilation on admission
- No understanding of spirometry or ventilation techniques
- Other condition that forbid the use of non invasive ventilation or spirometry as defined by french consensus conference (2006) on non invasive ventilation
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: Spirometry
|
Every two hours during the day with 10 maximum inspirations and at night if the patient is awake
|
실험적: Non invasive positive pressure ventilation
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At least one hour every four hour but may be maintained more if the patient chooses to or is asleep with the machine on.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Occurence of acute chest syndrome
기간: up to 2 months at maximum (duration of hospitalization)
|
up to 2 months at maximum (duration of hospitalization)
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2차 결과 측정
결과 측정 |
기간 |
---|---|
Pain
기간: up to 2 months at maximum (duration of hospitalization)
|
up to 2 months at maximum (duration of hospitalization)
|
Morphinic requirements
기간: up to 2 months at maximum (duration of hospitalization)
|
up to 2 months at maximum (duration of hospitalization)
|
Length of hospital stay
기간: up to 2 months at maximum (duration of hospitalization)
|
up to 2 months at maximum (duration of hospitalization)
|
Comfort
기간: up to 2 months at maximum (duration of hospitalization)
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up to 2 months at maximum (duration of hospitalization)
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Quality of sleep
기간: up to 2 months at maximum (duration of hospitalization)
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up to 2 months at maximum (duration of hospitalization)
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Claire Heilbronner, MD, PhD, Necker - Enfants Malades Hospital
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 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. .
혈관 폐쇄 위기에 대한 임상 시험
-
Centre Hospitalier Intercommunal Creteil모병
Spirometry에 대한 임상 시험
-
Pneumacare LtdCambridge University Hospitals NHS Foundation Trust; University of Cambridge완전한
-
Seattle Children's HospitalBoston University; University of Washington완전한
-
Wake Forest University Health Sciences완전한
-
Fundacio d'Investigacio en Atencio Primaria Jordi...Catalan Institute of Health완전한