Impact of Oximetry on Hospitalization in Acute Bronchiolitis
Impact of Oximetry on Hospitalization
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
-
-
Ontario
-
Toronto、Ontario、カナダ
- The Hospital for Sick Children
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：1
In this arm, patients are monitored with oximeters displaying true saturation values
|
Physicians will be presented with real saturations.
|
|
実験的：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Hospitalization for bronchiolitis
時間枠：72 hours from start of study
|
72 hours from start of study
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
The proportions of infants receiving supplemental oxygen in the ED
時間枠：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)
時間枠：Determined by outcome measure
|
Determined by outcome measure
|
|
Proportions of infants with unscheduled medical visits for bronchiolitis symptoms to any medical facility
時間枠：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
時間枠：0, 60, 120, 180, 240, 300, and 360 minutes
|
0, 60, 120, 180, 240, 300, and 360 minutes
|
協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。