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This study is designed to determine if patients using an incentive spirometer with visual and auditory signals will increase their use of the incentive spirometer and prevent lung complications.
The purpose of this study is to determine if the frequency of patients' use of physician ordered incentive spirometry increases with visual and auditory electronic encouragement (signals) compared to the no signal cohort.
Secondarily this study will correlate short term outcomes of study patients to known short term outcome data from the study site and published data to determine if there is a relationship between frequency of use and positive or outcomes or complications, as cited by peer reviewed literature.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Signal On | Patient Signals ON |
| |
| Signal Off | Patient Signals Off |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Signal On | Device | InSee monitor patient signals are on. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of successful inspiratory breaths attempts per day. | successful inspiratory breaths is defined as achieving the goal tidal volume | through hospitalization an average of 5 days |
| Total number of inspiratory breaths achieved per day. | Inspiratory breaths while using the incentive spirometer | throughout hospitalization an average of 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to achieve goal tidal volume. | Time in to achieve prescribed goal inspiratory tidal volume. | throughout hospitalization an average of 5 days |
| Post operative length of O2 use. | Length of time from surgery until 02 is discontinued. |
| Measure | Description | Time Frame |
|---|---|---|
| Intubation due to a respiratory diagnosis | Postoperative Intubation due to a respiratory diagnosis during hospitalization | throughout hospitalization an average of 5 days |
| Reintubation due to a respiratory diagnosis |
Inclusion Criteria:
Patients must meet all the following Inclusion criteria to be eligible for participation in the study:
Exclusion Criteria:
Patients meeting any of the following exclusion criteria at baseline will be excluded from study participation:
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Post Operative Inpatients prescribed incentive spirometry.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Martin, RN | Contact | 18582121728 | michael@tidalmed.tech | |
| Mehdi Arani | Contact | mehdi@tidalmed.tech |
| Name | Affiliation | Role |
|---|---|---|
| Hassan Study Director, M.D. | Tidal Medical Technologies | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tidal Reseach Site | Terminated | Silver Spring | Maryland | 20904 | United States | |
| Tidal Study Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29362219 | Background | Eltorai AEM, Baird GL, Eltorai AS, Pangborn J, Antoci V Jr, Cullen HA, Paquette K, Connors K, Barbaria J, Smeals KJ, Agarwal S, Healey TT, Ventetuolo CE, Sellke FW, Daniels AH. Incentive Spirometry Adherence: A National Survey of Provider Perspectives. Respir Care. 2018 May;63(5):532-537. doi: 10.4187/respcare.05882. Epub 2018 Jan 23. | |
| 34429138 |
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| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| throughout hospitalization an average of 5 days |
| Change in 02 flow rate. | Change in 02 flow rate delivered to the patient. | throughout hospitalization an average of 5 days |
| inpatient Pulmonary complication rates. | Pulmonary complications during hospitalization | throughout hospitalization an average of 5 days |
| Hospital discharge on O2. | If a study patient is discharged on 02. | throughout hospitalization an average of 5 days |
| Changes in Inspiratory volume. | Changes (- or +) in the inspiratory volume a patient is able to achieve. | throughout hospitalization an average of 5 days |
| Change in Inspiratory volume. | Postoperative change in inspiratory volume | throughout hospitalization an average of 5 days |
| Readmission for pulmonary complication | Readmission for pulmonary complication up to 30 days after hospital discharge | 30 days after discharge |
Reintubation due to a respiratory diagnosis during hospitalization
| throughout hospitalization an average of 5 days |
| ICU length of stay | Postoperative length of stay in ICU | throughout hospitalization an average of 5 days |
| Inpatient hospital length of stay | Postoperative length of stay in hospital | throughout hospitalization an average of 5 days |
| Change in SP02 | Postoperative Change in SP02 | throughout hospitalization an average of 5 days |
| Recruiting |
| Rochester |
| Minnesota |
| 55905 |
| United States |
|
| Tidal Study Site | Recruiting | New Brunswick | New Jersey | 08901 | United States |
|
| Sweity EM, Alkaissi AA, Othman W, Salahat A. Preoperative incentive spirometry for preventing postoperative pulmonary complications in patients undergoing coronary artery bypass graft surgery: a prospective, randomized controlled trial. J Cardiothorac Surg. 2021 Aug 24;16(1):241. doi: 10.1186/s13019-021-01628-2. |
| 34676618 | Background | Alwekhyan SA, Alshraideh JA, Yousef KM, Hayajneh F. Nurse-guided incentive spirometry use and postoperative pulmonary complications among cardiac surgery patients: A randomized controlled trial. Int J Nurs Pract. 2022 Apr;28(2):e13023. doi: 10.1111/ijn.13023. Epub 2021 Oct 22. |