- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04031768
Best Rest: Rest Time Before Blood Pressure Measurement Trial
Rest Time Before Blood Pressure Measurement Trial
The objectives of this study are to:
- Determine the impact of wait time before initiating BP measurement on BP variability
- Determine the difference in BP variability between measurements by amount of initial rest.
The investigators also aim to:
1. To determine the total time required to obtain a BP measurement.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Maryland
-
Baltimore, Maryland, Forente stater, 21287
- Johns Hopkins School of Medicine Division of Pediatric Nephrology
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Age 18-80 years
Exclusion Criteria:
- Presence of the following on both arms: rashes, gauze dressings, casts, edema, paralysis, tubes, open sores or wounds, withered arms, A-V shunts, or if blood has been drawn from arm within last week.
- Being mentally impaired, pregnant.
- Arm circumference exceeding 50 cm.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Screening
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Annen: 0-2-5-5 minutes rest group
The order of rest periods for participants randomized to this arm will be: 0 minutes 2 minutes 5 minutes 5 minutes |
Each participant will have 4 sets of 3 blood pressure measurements taken.
The participants will be randomized to the order in which they rest prior to each set of measurements.
|
Annen: 0-5-2-5 minutes rest group
The order of rest periods for participants randomized to this arm will be: 0 minutes 5 minutes 2 minutes 5 minutes |
Each participant will have 4 sets of 3 blood pressure measurements taken.
The participants will be randomized to the order in which they rest prior to each set of measurements.
|
Annen: 2-0-5-5 minutes rest group
The order of rest periods for participants randomized to this arm will be: 2 minutes 0 minutes 5 minutes 5 minutes |
Each participant will have 4 sets of 3 blood pressure measurements taken.
The participants will be randomized to the order in which they rest prior to each set of measurements.
|
Annen: 5-0-2-5 minutes rest group
The order of rest periods for participants randomized to this arm will be: 5 minutes 0 minutes 2 minutes 5 minutes |
Each participant will have 4 sets of 3 blood pressure measurements taken.
The participants will be randomized to the order in which they rest prior to each set of measurements.
|
Annen: 2-5-0-5 minutes rest group
The order of rest periods for participants randomized to this arm will be: 2 minutes 5 minutes 0 minutes 5 minutes |
Each participant will have 4 sets of 3 blood pressure measurements taken.
The participants will be randomized to the order in which they rest prior to each set of measurements.
|
Annen: 5-2-0-5 minutes rest group
The order of rest periods for participants randomized to this arm will be: 5 minutes 2 minutes 0 minutes 5 minutes |
Each participant will have 4 sets of 3 blood pressure measurements taken.
The participants will be randomized to the order in which they rest prior to each set of measurements.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Difference in Systolic Blood Pressure (mmHg)
Tidsramme: 90 minutes
|
Comparison of the average of 3 systolic BP measurements (mmHg) measured after 5 minutes rest with the average of 3 systolic blood pressure (SBP) measured after the other periods of rest (0 minutes, 2 minutes, second 5 minutes of rest)
|
90 minutes
|
Difference in Diastolic Blood Pressure (mmHg)
Tidsramme: 90 minutes
|
Comparison of the average of 3 diastolic BP measurements (mmHg) measured after 5 minutes rest with the average of 3 diastolic blood pressure (DBP) measured after the other periods of rest (0 minutes, 2 minutes, second 5 minutes of rest)
|
90 minutes
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Blood Pressure Variability (mmHg)
Tidsramme: 90 minutes
|
Difference between individual systolic and diastolic BP measurements (BP reading 1 - BP reading 2; BP reading 2 - BP reading 3) obtained per each rest period
|
90 minutes
|
Standard Deviation of Blood Pressures (mmHg)
Tidsramme: 90 minutes
|
Difference in standard deviation of the mean of 3 systolic and diastolic BPs obtained at each rest period
|
90 minutes
|
Coefficient of Variation of Blood Pressures
Tidsramme: 90 minutes
|
Difference in coefficient of variation (SD/mean) of 3 systolic and diastolic BPs obtained at each rest period
|
90 minutes
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Total time required to obtain a BP measurement (seconds)
Tidsramme: 90 minutes
|
For each rest time assignment, mean time from:
|
90 minutes
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Tammy Brady, MD, PhD, Johns Hopkins University
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IRB00214827
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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