NCT06101030 Comparing Use of Incentive Spirometry With and Without Reminder
| NCT ID | NCT06101030 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tidal Medical Technologies |
| Condition | Post Operative |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2024-01-16 |
| Primary Completion | 2025-09-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2024-01-16 with a primary completion date of 2025-09-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 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 Criteria: * 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.
Contact & Investigator
Hassan Study Director, M.D.
STUDY DIRECTOR
Tidal Medical Technologies
Frequently Asked Questions
Who can join the NCT06101030 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Post Operative. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06101030 currently recruiting?
Yes, NCT06101030 is actively recruiting participants. Contact the research team at michael@tidalmed.tech for enrollment information.
Where is the NCT06101030 trial being conducted?
This trial is being conducted at Silver Spring, United States, Rochester, United States, New Brunswick, United States.
Who is sponsoring the NCT06101030 clinical trial?
NCT06101030 is sponsored by Tidal Medical Technologies. The principal investigator is Hassan Study Director, M.D. at Tidal Medical Technologies. The trial plans to enroll 500 participants.