Status:
RECRUITING
Comparing Use of Incentive Spirometry With and Without Reminder
Lead Sponsor:
Tidal Medical Technologies
Conditions:
Post Operative
Eligibility:
All Genders
18+ years
Brief Summary
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.
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Patients must meet all the following Inclusion criteria to be eligible for participation in the study:
- Patient has undergone a qualifying surgical procedure.
- 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
- Patients meeting any of the following exclusion criteria at baseline will be excluded from study participation:
- Vulnerable Populations (Pregnant, minors, prisoners, those with significantly reduced mental acuity).
- 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.
Key Trial Info
Start Date :
January 16 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 7 2025
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06101030
Start Date
January 16 2024
End Date
September 7 2025
Last Update
April 10 2025
Active Locations (3)
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1
Tidal Reseach Site
Silver Spring, Maryland, United States, 20904
2
Tidal Study Site
Rochester, Minnesota, United States, 55905
3
Tidal Study Site
New Brunswick, New Jersey, United States, 08901