Safety and Feasibility of a Novel Device for Assessing Respiratory Function in Children
Safety and Feasibility of Utilizing a Novel Wearable Device (Leo) for Assessing Respiratory Function in Children With Respiratory Condition - a Pilot Early Phase Clinical Study
This is an early phase pilot study designed to test the safety and feasibility of using a novel, wireless, wearable device (Leo) for assessing respiratory parameters (lung volume, respiration rate, heart rate and indices related to tidal breathing flow volume loop) in children with respiratory condition (such as asthma).
There is no product currently on the market that is comparable to this novel Leo device
The study consists of a single visit to evaluate the feasibility and safety of using the Leo device on 20 children with clinically stable asthma.
Stable asthmatic children between the age of 3 and 6, inclusive, will be recruited.
There will be no disease-specific intervention, nor changes to the participant's care management program for their asthma.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Colorado
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Aurora、Colorado、アメリカ、80045
- Children's Colorado Hospital
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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:
- Children aged ≥3 years old and ≤18 years old at time of consent
- Children with a legal guardian able to sign consent for study participation
- Children and caregivers able to read and understand English or Spanish
- Investigator confirmation for diagnosis of clinically stable respiratory condition, such as clinically diagnosed asthma
- Children who are able to follow instructions and complete oscillometry and tidal breathing tasks
Exclusion Criteria:
- - Children <3 and >18 years of age
- Adults (age ≥ 18 years)
- Children with complex medical conditions which may hinder their ability to complete protocol assessments
- Children who do not have a legal guardian to sign informed consent form
- Children with an active skin condition involving the area on the chest wall where the Leo device will be attached. E.g. inflamed and/or infected eczema or other skin conditions involving the anterior chest wall at the time of recruitment
- Child is determined not eligible by the assessment of the PI
- Fever within the 4 weeks prior to enrollment
- Children with any implanted medical devices, E.g. cardiac pacemaker
- Children with any history of known allergic reaction to adhesives or hydrogels, as the ones used with the Leo device
- Children who have taken a bronchodilator in the last 8-24 hours prior to study visit, depending on the type of medication.
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：デバイスの実現可能性
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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他の：Oscillometry + Pneumotach Procedure with Leo Device measurements
All patients will undergo oscillometry procedure, followed by pneumotach procedure to measure tidal volume in different sitting positions. The Leo device will be worn throughout both procedures to measure the chest electrical impedance and compare against pneumotach measurements. Oscillometry and pneumotach are part of standard of care. |
Children's respiratory flow and volume measurements will be continuously recorded using the Leo device during oscillometry and pneumotach procedures.
他の名前：
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Slow vital capacity from Leo device
時間枠：Baseline
|
Agreement and correlation in the lung function parameters derived using the respiratory impedance signals recorded from Leo device, compared to the pneumotachograph (PNT) device.
The PNT device readings will be considered the standard of care, and compared against the Leo device to evaluate for device feasibility.
This will be done before and after administration of bronchodilator.
|
Baseline
|
|
Slow vital capacity from PNT device
時間枠：Baseline
|
Agreement and correlation in the lung function parameters derived using the respiratory impedance signals recorded from Leo device, compared to the pneumotachograph (PNT) device.
The PNT device readings will be considered the standard of care, and compared against the Leo device to evaluate for device feasibility.
This will be done before and after administration of bronchodilator.
|
Baseline
|
|
Tidal breathing from Leo device
時間枠：Baseline
|
Agreement and correlation in tidal breathing parameters between Leo and the pneumotachograph (PNT) device.
The PNT device parameters are considered standard of care, and will be compared against Leo device to evaluate for device feasibility.
This will be done before and after administration of bronchodilator.
|
Baseline
|
|
Tidal breathing from PNT device
時間枠：Baseline
|
Agreement and correlation in tidal breathing parameters between Leo and the pneumotachograph (PNT) device.
The PNT device parameters are considered standard of care, and will be compared against Leo device to evaluate for device feasibility.
This will be done before and after administration of bronchodilator.
|
Baseline
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Usability
時間枠：Baseline
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Clinician, patient and caregiver usability feedback on the use of the Leo device through an IRB approved participant questionnaire.
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Baseline
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Andrew Liu、Children's Hospital Colorado
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
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