Comparing Use of Incentive Spirometry With and Without Reminder

Recruiting

• Conditions: Post Operative
• Interventions: Device: Signal On

• Registration Number: NCT06101030
• Lead Sponsor: Tidal Medical Technologies

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-10-18
• Study First Submitted QC: 2023-10-23
• Study First Posted: 2023-10-25
• Study Start: 2024-01-16
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-10
• Primary Completion: 2025-09-03
• Study Completion: 2025-09-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Signal On	Signal On	Patient Signals ON

Primary Outcome Measures

Name	Time	Method
Number of successful inspiratory breaths attempts per day.	through hospitalization an average of 5 days	successful inspiratory breaths is defined as achieving the goal tidal volume
Total number of inspiratory breaths achieved per day.	throughout hospitalization an average of 5 days	Inspiratory breaths while using the incentive spirometer

Secondary Outcome Measures

Name	Time	Method
Change in Inspiratory volume.	throughout hospitalization an average of 5 days	Postoperative change in inspiratory volume
Time to achieve goal tidal volume.	throughout hospitalization an average of 5 days	Time in to achieve prescribed goal inspiratory tidal volume.
Change in 02 flow rate.	throughout hospitalization an average of 5 days	Change in 02 flow rate delivered to the patient.
Post operative length of O2 use.	throughout hospitalization an average of 5 days	Length of time from surgery until 02 is discontinued.
inpatient Pulmonary complication rates.	throughout hospitalization an average of 5 days	Pulmonary complications during hospitalization
Hospital discharge on O2.	throughout hospitalization an average of 5 days	If a study patient is discharged on 02.
Changes in Inspiratory volume.	throughout hospitalization an average of 5 days	Changes (- or +) in the inspiratory volume a patient is able to achieve.
Readmission for pulmonary complication	30 days after discharge	Readmission for pulmonary complication up to 30 days after hospital discharge

Trial Locations

Locations (2)

Tidal Reseach Site; 🇺🇸 Silver Spring, Maryland, United States

Tidal Study Site; 🇺🇸 New Brunswick, New Jersey, United States