Recruiting

Incentive Spirometry

Sponsor:

Tidal Medical Technologies

Code:

NCT06101030

Conditions

Post Operative

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Signal On

Study Details

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.

Conditions

Post Operative

Study ID

NCT06101030

Start date

Jan 16, 2024

Status verified date

Apr, 2025

Completion date

Sep 7, 2025

Anticipated

Primary completion date

Sep 3, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Signal On

Patient Signals ON

Signal Off

Patient Signals Off

Interventions

Signal On

InSee monitor patient signals are on.

Primary outcome measure

  • Number of successful inspiratory breaths attempts per day. [ Time Frame: through hospitalization an average of 5 days ]
  • Total number of inspiratory breaths achieved per day. [ Time Frame: throughout hospitalization an average of 5 days ]

Central Contacts and Locations

Central contacts

Michael Martin, RN

18582121728michael@tidalmed.tech

Mehdi Arani

mehdi@tidalmed.tech

Locations

Tidal Study Site

Recruiting

Rochester, Minnesota, United States, 55905

Tidal Study Site

Recruiting

New Brunswick, New Jersey, United States, 08901

More Information

Sponsor

Tidal Medical Technologies

Last update posted

Apr 10, 2025

Last verified

Apr, 2025

Keywords

  • Incentive spirometry
  • Post Operative
  • compliance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Tidal Medical Technologies on 2025-04-10.