- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00673946
Impact of Oximetry on Hospitalization in Acute Bronchiolitis
Impact of Oximetry on Hospitalization
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This is the first bronchiolitis study to examine the clinical and economic impact of making disposition decision on primarily clinical grounds, while blinding the physicians to oxygen saturations by providing them with either true saturation measurements or those which are 3 percentage points above the true values. Although physiologically insignificant and within the measurement error of the instrument, this difference has been shown to be perceived as clinically relevant and to have a major hypothetical impact on disposition, without any evidence to support this belief.
We hope to find out if children with oxygen saturations above or in the vicinity of the threshold recommended for initiation of oxygen therapy by the AAP can be safely discharged based on their clinical appearance rather than to have their hospitalization dictated by a locally defined number. This study will hopefully provide much needed evidence necessary to help us interpret the oximetry results more meaningful which may in turn lead to fewer hospitalizations, shorter length of hospital stay and lower health care costs.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
-
-
Ontario
-
Toronto, Ontario, Canada
- The Hospital for Sick Children
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Acute bronchiolitis
- Age 4 weeks to 12 months
- Baseline Respiratory Disease Assessment Instrument (RDAI) ≥ 3 points
- Informed consent
- Availability of a telephone
Exclusion Criteria:
- Pre-existing pulmonary or cardiac distress, neuromuscular disease, congenital or acquired airway anomalies, hemoglobinopathies, or chronic hypoxia
- Severe respiratory distress, defined as the retraction component on the RDAI as 8 out of possible 9 points
- True baseline oxygen saturation less than 88% in room air
- Transfers from other institutions
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: 1
In this arm, patients are monitored with oximeters displaying true saturation values
|
Physicians will be presented with real saturations.
|
Eksperimentel: 2
In this arm, patients are monitored with oximeters with displayed saturations 3 percentage points above true values
|
Physicians will be presented with saturation measurements three percentage points above the true values.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Hospitalization for bronchiolitis
Tidsramme: 72 hours from start of study
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72 hours from start of study
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
The proportions of infants receiving supplemental oxygen in the ED
Tidsramme: 72 hours from start the study
|
72 hours from start the study
|
Length of stay in the ED (from the time of arrival to the disposition decision)
Tidsramme: Determined by outcome measure
|
Determined by outcome measure
|
Proportions of infants with unscheduled medical visits for bronchiolitis symptoms to any medical facility
Tidsramme: 72 hours from start of study.
|
72 hours from start of study.
|
Proportion of the ED staff/fellows in "strong agreement" or "agreement" with discharge
Tidsramme: 0, 60, 120, 180, 240, 300, and 360 minutes
|
0, 60, 120, 180, 240, 300, and 360 minutes
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
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
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1000011675
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