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Search / Trial NCT06101030

Comparing Use of Incentive Spirometry With and Without Reminder

Launched by TIDAL MEDICAL TECHNOLOGIES · Oct 23, 2023

Trial Information

Current as of July 09, 2025

Recruiting

Keywords

Incentive Spirometry Post Operative Compliance

ClinConnect Summary

This clinical trial is studying whether using an incentive spirometer, a device that helps patients take deep breaths after surgery, is more effective when it includes reminders through sounds and lights. The goal is to see if these reminders can help patients use the spirometer more often, which could help prevent lung problems after surgery.

To participate in this study, patients need to be at least 18 years old and have had a specific type of surgery where using an incentive spirometer is recommended. They should also be able to understand and follow the instructions for using the device. However, certain patients are not eligible, including those who are pregnant, minors, or have serious mental health issues that could affect their ability to follow the study rules. If you decide to join the study, you will be using the spirometer as directed, and you may receive reminders to help you remember to use it.

Gender

ALL

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.

About Tidal Medical Technologies

Tidal Medical Technologies is an innovative clinical trial sponsor dedicated to advancing medical breakthroughs through rigorous research and development. Specializing in the creation and evaluation of cutting-edge medical devices and therapeutics, Tidal Medical Technologies is committed to enhancing patient outcomes and driving efficiency in healthcare delivery. With a focus on collaboration and transparency, the organization partners with leading clinical research institutions to ensure the highest standards of safety and efficacy in its studies. Through its commitment to scientific excellence and ethical practices, Tidal Medical Technologies aims to contribute significantly to the future of medicine.

Locations

Silver Spring, Maryland, United States

Rochester, Minnesota, United States

New Brunswick, New Jersey, United States

Galveston, Texas, United States

Patients applied

0 patients applied

Trial Officials

Hassan Study Director, M.D.

Study Director

Tidal Medical Technologies

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported