Using incentive spirometry with reminders to improve lung health after surgery

Comparing Post Operative Utilization of Incentive Spirometry With and Without Electronic Patient Reminder

This study is testing if using an incentive spirometer with reminders can help patients who had surgery use it more often and improve their lung health.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tidal Medical Technologies (industry)
• Locations: 3 sites (Silver Spring, Maryland and 2 other locations)
• Trial ID: NCT06101030 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate whether the use of an incentive spirometer with visual and auditory signals enhances patient compliance compared to those without such reminders. It will assess the frequency of spirometer use among post-operative patients and correlate this with short-term health outcomes to identify any potential benefits. The study will involve patients who have undergone qualifying surgical procedures and have been prescribed incentive spirometry as part of their care.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and over who have undergone a qualifying surgical procedure and have been prescribed incentive spirometry.

Not a fit: Patients who are part of vulnerable populations or for whom incentive spirometry is deemed inappropriate will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved lung health and reduced complications for post-operative patients.

How similar studies have performed: While the approach of using reminders for incentive spirometry is not widely tested, similar studies have shown promise in enhancing patient compliance in other health interventions.

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.

Where this trial is running

Silver Spring, Maryland and 2 other locations

• Tidal Reseach Site — Silver Spring, Maryland, United States (TERMINATED)
• Tidal Study Site — Rochester, Minnesota, United States (RECRUITING)
• Tidal Study Site — New Brunswick, New Jersey, United States (RECRUITING)

Study contacts

• Study coordinator: Michael Martin, RN

Conditions: Post Operative, Incentive spirometry, compliance