The Digital Incentive Spirometer (DIS): Improving Adherence to Incentive Spirometry (DIS)
A Behavioral Study of Digital Technology for Improving Post-Operative Incentive Spirometer Adherence
調査の概要
詳細な説明
This study is a prospective, randomized, participant blinded, single center, clinical trial to ascertain whether a smartphone connected digital incentive spirometer, the Smartpeakflow™, can improve participant adherence to prescribed incentive spirometer exercises. A control group will be given the Beth Israel Deaconess Medical Center (BIDMC) standard Voldyne Incentive Spirometer with an attached microcontroller that will record use of the spirometer. The study group will be given the Smartpeakflow ™ connected to an android motherboard (microcomputer, aka smartphone) running Android OS, that will then record use and store this data on the smartphone itself. Participants will then use an app on the BIDMC provided smartphone to view their usage and receive encouragement to continue using their device. All data on use will be recorded locally and there will be no internet connection or communication with participant through this device at any time.
The study is designed as a technology evaluation to assess feasibility, usability and assess for early impact on our outcome measures. The investigators plan to enroll up to 50 participants to participate in this study.
At the time of enrollment, participants who meet the inclusion criteria, and none of the exclusion criteria, will be asked to opt in to the study. Participants will read information about the study and research staff will explain what it means to "opt in". Prospective participants will be given ample time to read the informed consent form and ask any questions.
Once enrolled, participants will be randomized electronically to either the study group or control group. Participants that are randomized to the control group will have no further training or instructions at the Pre-Anesthesia Testing Clinic. Participants that are in the study group will be instructed on how to use the smartphone application and device which will then be provided to them in the Post Anesthesia Care Unit after their surgery. Both groups will retain and utilize the spirometers throughout their hospital stay, and the devices will be collected by the investigators when the participant is discharged from the hospital.
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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Massachusetts
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Boston、Massachusetts、アメリカ、02215
- BIDMC
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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:
- American Society of Anesthesiologists Physical Class (ASA) 1-3 patients undergoing elective Surgery at BIDMC requiring Incentive Spirometer use in the post-op period
- Greater than 18 years of age.
- Required to have a Pre-Anesthesia Testing Clinic Appointment
- Able to understand and sign a study consent form
- Able to understand and utilize a smartphone application
Exclusion Criteria:
- Diagnosis of Obstructive Sleep Apnea (OSA), treatment with CPAP or BIPAP for OSA
- Lack of regular smartphone use, or visual, mental or motor impairment that impedes use of smartphone
- Upper extremity surgery resulting in temporary or permanent inability to use two hands with spirometer device
- ASA 4 or greater, any ASA-E status (emergency surgical procedure)
- Suspected or established respiratory infection
- Previous spontaneous pneumothorax
- Severe pulmonary disease, or use of home O2
- Does not speak or understand English
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：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：Passive Arm
This arm uses a passive tracking device to assess the number of times a patient uses their prescribed incentive spirometer.
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実験的：Smartphone Arm
This arm uses a smartphone connected device and smartphone application to remind and encourage patients to use the spirometer as well as track the number of times they utilize the spirometer.
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The smartphone arm will have an associated smartphone application, available in kiosk mode, that will remind and encourage patient to utilize the spirometer and provide a "gamified" application for that patient to do so.
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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 |
|---|---|---|
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Adherence to prescribed post-operative incentive spirometer exercises
時間枠：Enrollment after patient finishes their surgery and data collection continues until patient is discharged home, or up to 2 weeks, whichever is sooner.
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The primary outcome of the study will be a measure of how adherent the participant has been to the prescribed post-operative incentive spirometer exercises.
Participants are prescribed ten breathing exercises per hour using the spirometer and the electronic devices in both arms will record how often the participant utilizes the device, measured on an hourly basis.
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Enrollment after patient finishes their surgery and data collection continues until patient is discharged home, or up to 2 weeks, whichever is sooner.
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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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Incidence of Post-Operative Pulmonary Complications
時間枠：Enrollment after patient finishes their surgery and data collection continues until patient is discharged home, or up to 2 weeks, whichever is sooner.
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Pulmonary related complications and events such as radiographic exams, increased utilization of oxygen therapy, use of accessory breathing devices (BiPAP, CPAP).
The measure will be dichotomous outcome based on whether event took place or not.
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Enrollment after patient finishes their surgery and data collection continues until patient is discharged home, or up to 2 weeks, whichever is sooner.
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Incidence of post-operative respiratory infection
時間枠：Enrollment after patient finishes their surgery and data collection continues until patient is discharged home, or up to 2 weeks, whichever is sooner.
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Diagnosis of respiratory infection, such as pneumonia, in the post-operative period.
The measure will be dichotomous outcome based on whether event took place or not.
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Enrollment after patient finishes their surgery and data collection continues until patient is discharged home, or up to 2 weeks, whichever is sooner.
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Incidence of clinically relevant complications
時間枠：Enrollment after patient finishes their surgery and data collection continues until patient is discharged home, or up to 2 weeks, whichever is sooner.
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Diagnosis of clinically relevant complications such as surgical site infection, falls, delerium, or any other non-pulmonary event in the post-operative period.
The measure will be dichotomous outcome based on whether event took place or not.
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Enrollment after patient finishes their surgery and data collection continues until patient is discharged home, or up to 2 weeks, whichever is sooner.
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協力者と研究者
捜査官
- 主任研究者：Charlie Safran, MD MS、Beth Israel Deaconess Medical Center
出版物と役立つリンク
一般刊行物
- do Nascimento Junior P, Modolo NS, Andrade S, Guimaraes MM, Braz LG, El Dib R. Incentive spirometry for prevention of postoperative pulmonary complications in upper abdominal surgery. Cochrane Database Syst Rev. 2014 Feb 8;2014(2):CD006058. doi: 10.1002/14651858.CD006058.pub3.
- Branson RD. The scientific basis for postoperative respiratory care. Respir Care. 2013 Nov;58(11):1974-84. doi: 10.4187/respcare.02832.
- Warner DO. Preventing postoperative pulmonary complications: the role of the anesthesiologist. Anesthesiology. 2000 May;92(5):1467-72. doi: 10.1097/00000542-200005000-00037. No abstract available.
- THOREN L. Post-operative pulmonary complications: observations on their prevention by means of physiotherapy. Acta Chir Scand. 1954 May 5;107(2-3):193-205. No abstract available.
- Bartlett RH, Gazzaniga AB, Geraghty TR. Respiratory maneuvers to prevent postoperative pulmonary complications. A critical review. JAMA. 1973 May 14;224(7):1017-21. No abstract available.
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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