Comparing Use of Incentive Spirometry With and Without Reminder
Recruiting now
Conditions studied: Post Operative
In brief
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.
Key facts
- Study ID
- NCT06101030
- Run by
- Tidal Medical Technologies
- People needed
- 500
- Starts
- 2024-01-16
- Expected to finish
- 2025-09-07
- Last updated by the study team
- 2025-04-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Tidal Study Site — Rochester, Minnesota, United States (enrolling)
- Tidal Study Site — New Brunswick, New Jersey, United States (enrolling)
- Tidal Reseach Site — Silver Spring, Maryland, United States
Full record on ClinicalTrials.gov
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