- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01306201
Novel Non-Invasive Monitoring Parameter in a Hospital Setting
A Novel Cardio-Respiratory Parameter in a Hospital Setting
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Colorado
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Denver, Colorado, Forenede Stater, 80262
- The University of Colorado Health Sciences Center (UCHSC)
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Ohio
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Columbus, Ohio, Forenede Stater, 43210
- The Ohio State University Medical Center (OSUMC)
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Subjects 18 years old or older
- Written informed consent from the patient or their legally authorized representative before initiation of any study-related procedures
- Subjects on general care floor
Exclusion Criteria:
- Severe contact allergies to standard adhesive materials
- Abnormalities that may prevent proper application of the device
- Women who are pregnant or lactating
- Subjects with significant arrhythmia
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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In-patient Volunteers
In-patients from the hospital who choose to participate in the study
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
The Covidien Nellcor Respiration Rate Software Shall Determine Respiration Rate Measured as Mean and Standard Deviation With Accuracy That is Non-inferior to Predicate Device.
Tidsramme: Participants were monitored for average of 30 minutes
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Mean and standard deviations of respiration rates collected from patients in the hospital settings were compared between Covidien Respiration Rate Software, Transthoracic Impedance and End-Tidal Carbon Dioxide Waveforms.
Each patient served as its own control.
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Participants were monitored for average of 30 minutes
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
The Covidien Nellcor Respiration Rate Software Shall Calculate Respiration Rate With a Root Mean Square Difference (RMSD) of < 3 Breaths Per Minute Compared With a End-Tidal Carbon Dioxide Waveforms, With 95% Confidence.
Tidsramme: Participants were monitored on average for 30 minutes
|
The data used for analysis consisted of multiple simultaneous measures of RR_TTI, RR_V1.0 and RR_EtCO2 for each subject. Given N sets of simultaneous RR values for each of P patients, the simultaneous RR values were used to calculate a pair of RMSD values for each subject. The two RMSD values, RMSDRR_V1.0_vs_EtCO2, and RMSDTTI_vs_EtCO2, quantify the mean absolute difference in simultaneous estimates of respiratory rate between RR_V1.0 compared with RR_EtCO2 and RR_TTI compared with RR_EtCO2, respectively for the subjects with 95% confidence of mean ± 3.38 BrPM. The Measure type is Number and represents the RMSD of Covidien Nellcor Respiration Rate Software |
Participants were monitored on average for 30 minutes
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Sergio Bergese, MD, The Ohio State Medical Center, Dept of Anesthesia
- Ledende efterforsker: Robert McIntyre, MD, University of Colorado Denver, School of Medicine dept of Surgery Division of GI, Tumor and Endocrine Surgery
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- COVMOPR0131
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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