Comparing Use of Incentive Spirometry With and Without Reminder
NCT ID: NCT06101030
Last Updated: 2025-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2024-01-16
2025-09-07
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Signal On
Patient Signals ON
Signal On
InSee monitor patient signals are on.
Signal Off
Patient Signals Off
No interventions assigned to this group
Interventions
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Signal On
InSee monitor patient signals are on.
Eligibility Criteria
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Inclusion Criteria
* Patient is aged 18 years or over.
* Patient has incentive spirometry ordered or incentive spirometry must be part of the study site's standard of care which is implemented by hospital staff.
* Patient is able to comply with all study required incentive spirometry instructions.
* Patient is without severe hearing or impaired visual acuity deficiency such that they cannot hear or see the audible and visual signal for the InSee monitor.
Exclusion Criteria
* Patients where incentive spirometry is inappropriate (patients with Tractotomy, patients who are hemodynamically unstable, patients in reverse isolation due to infection).
* Patients with a history of prior non-compliance or the presence or history of psychiatric condition (including drug or alcohol addiction), or cognitive issue which would in the opinion of the investigator, make it difficult for the patient to comply with the study procedures or follow the investigators instructions.
* Any medical condition that, in the opinion of the investigator, would place the patient at increased risk if they participated.
* Any Physician determination that the patient should not participate.
18 Years
ALL
No
Sponsors
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Tidal Medical Technologies
INDUSTRY
Responsible Party
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Principal Investigators
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Hassan Study Director, M.D.
Role: STUDY_DIRECTOR
Tidal Medical Technologies
Locations
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Tidal Reseach Site
Silver Spring, Maryland, United States
Tidal Study Site
Rochester, Minnesota, United States
Tidal Study Site
New Brunswick, New Jersey, United States
Countries
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Central Contacts
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Facility Contacts
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William LeTourneau
Role: primary
Brian Raffel, DO
Role: primary
References
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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.
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.
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.
Other Identifiers
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InSee 202301
Identifier Type: -
Identifier Source: org_study_id
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