Comparing Use of Incentive Spirometry With and Without Reminder

Last updated: April 7, 2025
Sponsor: Tidal Medical Technologies
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Signal On

Clinical Study ID

NCT06101030
InSee 202301
  • Ages > 18
  • All Genders

Study 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

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 thestudy 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 thatthey cannot hear or see the audible and visual signal for the InSee monitor.

Exclusion

Exclusion Criteria:

  • Patients meeting any of the following exclusion criteria at baseline will beexcluded from study participation:

  • Vulnerable Populations (Pregnant, minors, prisoners, those with significantlyreduced mental acuity).

  • Patients where incentive spirometry is inappropriate (patients with Tractotomy,patients who are hemodynamically unstable, patients in reverse isolation due toinfection).

  • Patients with a history of prior non-compliance or the presence or history ofpsychiatric condition (including drug or alcohol addiction), or cognitive issuewhich would in the opinion of the investigator, make it difficult for thepatient to comply with the study procedures or follow the investigatorsinstructions.

  • Any medical condition that, in the opinion of the investigator, would place thepatient at increased risk if they participated.

  • Any Physician determination that the patient should not participate.

Study Design

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: Signal On
Phase:
Study Start date:
January 16, 2024
Estimated Completion Date:
September 07, 2025

Study 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 the no signal cohort.

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.

Connect with a study center

  • Tidal Reseach Site

    Silver Spring, Maryland 20904
    United States

    Terminated

  • Tidal Study Site

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Tidal Study Site

    New Brunswick, New Jersey 08901
    United States

    Active - Recruiting

  • Tidal Study Site

    Galveston, Texas 77555
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.