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OpenTrials
Completed

NCT Number: NCT00673946

Impact of Oximetry on Hospitalization in Acute Bronchiolitis

To determine, in previously healthy infants 6 weeks to 12 months of age, diagnosed with acute bronchiolitis and monitored by hourly oximetry, if the probability of hospitalization within 72 hours of arrival in those whose oxygen saturation display is manipulated 3 percentage points above the true measurements is significantly lower in comparison to those whose monitors display true saturations.

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Key information

Age range

6 week–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Hospital for Sick Children

Toronto, Ontario, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

True saturation values displayed

Other

Physicians will be presented with real saturations.

Altered saturation values displayed.

Other

Physicians will be presented with saturation measurements three percentage points above the true values.

Primary outcomes

  1. Hospitalization for bronchiolitis

    Time frame: 72 hours from start of study

Secondary outcomes

  1. The proportions of infants receiving supplemental oxygen in the ED

    Time frame: 72 hours from start the study

  2. Length of stay in the ED (from the time of arrival to the disposition decision)

    Time frame: Determined by outcome measure

  3. Proportions of infants with unscheduled medical visits for bronchiolitis symptoms to any medical facility

    Time frame: 72 hours from start of study.

  4. Proportion of the ED staff/fellows in "strong agreement" or "agreement" with discharge

    Time frame: 0, 60, 120, 180, 240, 300, and 360 minutes

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

Impact of Oximetry on Hospitalization

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
May 7, 2008
Registry last updated
Dec 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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