N/A
Completed N=1,898
Aligning Pulse Oximetry With Guidelines
Source: ClinicalTrials.gov NCT04178941 ↗Enrolled (actual)
1,898
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcomePrimary: Audit & Feedback Feasibility Using Adapted Item From Feasibility of Intervention Measure (FIM) — 222; 331; 86; 20 Participants
Summary
The primary objective is to measure the feasibility, acceptability, and appropriateness of audit and feedback with educational outreach as a strategy to align continuous pulse oximetry use in stable bronchiolitis patients with evidence and guideline recommendations.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Audit & Feedback Feasibility Using Adapted Item From Feasibility of Intervention Measure (FIM) |
222; 331; 86; 20; 0 | — |
| PRIMARY Audit & Feedback Acceptability Using Adapted Item From Acceptability of Intervention Measure (FIM) |
305; 305; 46; 2; 1 | — |
| PRIMARY Audit & Feedback Appropriateness Using Adapted Item From Intervention Appropriateness Measure (IAM) |
280; 337; 37; 4; 1 | — |
| SECONDARY Hospital-level Percentage of Patients Continuously Monitored When Not Receiving Supplemental Oxygen |
236 | — |
| SECONDARY Sensitivity of the Presence of Electronic Health Record (EHR) Data From the Medical Monitoring Device for Actual Monitoring at the Bedside in Bronchiolitis. Sensitivity is Also Referred to as the "True Positive Rate." |
92 | — |
| SECONDARY Specificity of the Absence of Electronic Health Record Data From the Medical Monitoring Device for Absence of Monitoring at the Bedside in Bronchiolitis. Specificity is Also Referred to as the "True Negative Rate." |
554 | — |
| SECONDARY Positive Predictive Value (PPV) of the Presence of Electronic Health Record Data From the Medical Monitoring Device for Actual Monitoring at the Bedside in Bronchiolitis. |
92 | — |
| SECONDARY Negative Predictive Value of the Absence of Electronic Health Record Data From the Medical Monitoring Device for Absence of Monitoring at the Bedside in Bronchiolitis. |
554 | — |
Eligibility Criteria
Inclusion Criteria
- Primary subjects - Hospital staff
- Nurses, physicians, physician assistants, nursing assistants, or respiratory therapists
- Providing care to patients on units included in the study.
- Secondary subjects - Patients
- Males or females 8 weeks through 23 months old hospitalized on non-Intensive Care Unit (ICU) wards
- Cared for by generalist inpatient services (e.g. general pediatrics, hospital medicine)
- Primary diagnosis of acute bronchiolitis according to hospital chart
- Not currently requiring supplemental oxygen therapy or nasal cannula flow at an fraction of inspired oxygen in the air (FiO2) of 21% (room air flow)
Exclusion Criteria
- Primary subjects - Hospital staff
- None. Staff may self-exclude by choosing not to interact with the electronic communications and may choose to not attend meetings where the intervention is discussed.
- Secondary subjects - Patients
- Premature birth: <28 weeks completed gestation
- Cyanotic congenital heart disease
- Pulmonary hypertension
- Home oxygen or positive pressure ventilation requirement
- Tracheostomy
- Neuromuscular disease
- Immunodeficiency
- Cancer
- Historical, current, or suspected diagnosis of heart failure, myocarditis, or arrhythmia
- Historical, current, or suspected diagnosis of Coronavirus disease 2019 (COVID-19)
Data sourced from ClinicalTrials.gov (NCT04178941). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.