Intermittent Negative Pressure to Improve Blood Flow in Patients With Peripheral Artery Disease: Optimal Pulse Pressure Regime
3. december 2019 opdateret af: Jonny Hisdal, Oslo University Hospital
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.
Recent studies have shown that applying intermittent negative pressure (INP) with short negative pressure (-40 mmHg) pulses to the lower extremities increase arterial blood flow velocity and skin blood flow.
However, the optimal magnitude of negative pressure to improve blood flow is not known, and needs further investigation.
Peripheral arterial blood flow velocity, skin blood flow and skin temperature in the foot will be recorded at different levels of oscillating negative pressure to identify a pressure range which is practically, while at the same time induce clinically relevant changes in blood flow parameters.
Heart rate and blood pressure will be recorded to monitor the effects on the central circulation.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
16
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
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Oslo, Norge, 0586
- Department of Vascular diseases, Oslo University Hosptital, Aker
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 96 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Arterial blood flow
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Skin blood flow
Tidsramme: At time of intervention
|
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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Jonny Hisdal, PhD, Department of Vascular diseases, Oslo University Hospital, Aker
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
15. maj 2018
Primær færdiggørelse (Faktiske)
30. september 2018
Studieafslutning (Faktiske)
31. januar 2019
Datoer for studieregistrering
Først indsendt
22. maj 2018
Først indsendt, der opfyldte QC-kriterier
5. juni 2018
Først opslået (Faktiske)
6. juni 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. december 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. december 2019
Sidst verificeret
1. december 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SD0321063
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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