Intermittent Negative Pressure to Improve Blood Flow in Patients With Peripheral Artery Disease: Optimal Pulse Pressure Regime
Intermittent Negative Pressure to Improve Blood Flow in Patients With Peripheral Artery Disease. An Experimental Study to Investigate the Optimal Pulse Pressure Regime to Improve Blood Flow.
연구 개요
상세 설명
Cross sectional study design. The equipment for physiological measurements will be attached to the patient, and the foot will then be placed in the pressure chamber. The device induces pulses of 10 sec negative pressure, and 7 sec of atmospheric pressure. Pressure levels of 0 mmHg, -10mmHg, -20 mmHg, -40 mmHg and -60 mmHg will be tested.
Patients will be recruited from the out-patient clinic at Department of Vascular Surgery, Oslo University Hospital, Aker.
Inclusion criteria:
Diagnosed peripheral artery disease (PAD), Ankle-Brachial Index <0.9 Outcome measures:
Arterial blood flow: Ultrasound Doppler from peripheral arteries in the foot.
Skin blood flow: Laser Doppler to measure acral skin blood perfusion.
Skin temperature
Systemic blood pressure: Finger arterial pressure will continuously be acquired by a photoplethysmographic pressure recording device (Finometer).
Ankle brachial index
Pressure recordings inside the pressure chamber: Continuously monitoring of pressure within the pressure chamber using a digital differential manometer.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Oslo, 노르웨이, 0586
- Department of Vascular diseases, Oslo University Hosptital, Aker
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Diagnosed peripheral artery disease
- Ankle-Brachial Index <0.9
Exclusion Criteria:
- Incapable to make an informed consent
- Diagnosis of severe psychiatric disease
- Severe heart disease such as unstable angina pectoris, severe heart failure (NYHA IV), severe valve failure
- Systemic infection
- Use of vasoactive substances
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Optimal negative pulse pressure regime
The equipment for physiological measurements will be attached to the patient, and the foot will then be placed in the pressure chamber of the intermittent negative pressure device.
The device induces pulses of 10 sec negative pressure, and 7 sec of atmospheric pressure.
Pressure levels of 0 mmHg, -10 mmHg, -20 mmHg, -40 mmHg and -60 mmHg will be tested, with washout periods of 5 minutes between the different pressure levels.
The order of the different negative pressure levels will be randomized to avoid causal interference.
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Pressure levels of 0 mmHg, -10 mmHg, -20 mmHg, -40 mmHg and -60 mmHg will be tested, with washout periods of 5 minutes between the different pressure levels
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Arterial blood flow
기간: At time of intervention
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Continuously Ultrasound Doppler measurements of the dorsalis pedis artery or tibialis posterior artery to monitor changes in arterial blood flow during 5 min sequences of intermittent negative pressure treatment.
Pressure levels of 0, -10 mmHg, -20 mmHg, -40 mmHg and -60 mmHg will be tested.
Systolic pressures in the arm and the ankle will be assessed before the intervention to describe the patients severity of disease.
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At time of intervention
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Skin blood flow
기간: At time of intervention
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Continuously Laser Doppler measurements from the pulp of the first toe to monitor changes in acral skin perfusion during 5 min sequences of intermittent negative pressure treatment.
Pressure levels of 0, -10 mmHg, -20 mmHg, -40 mmHg and -60 mmHg will be tested.
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At time of intervention
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Jonny Hisdal, PhD, Department of Vascular diseases, Oslo University Hospital, Aker
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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