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Comparing Use of Incentive Spirometry With and Without Reminder

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06101030
Enrollment
500
Registered
2023-10-25
Start date
2024-01-16
Completion date
2025-09-07
Last updated
2025-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Operative

Keywords

Incentive spirometry, Post Operative, compliance

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.

Interventions

DEVICESignal On

InSee monitor patient signals are on.

Sponsors

Tidal Medical Technologies
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of successful inspiratory breaths attempts per day.through hospitalization an average of 5 dayssuccessful inspiratory breaths is defined as achieving the goal tidal volume
Total number of inspiratory breaths achieved per day.throughout hospitalization an average of 5 daysInspiratory breaths while using the incentive spirometer

Secondary

MeasureTime frameDescription
Change in 02 flow rate.throughout hospitalization an average of 5 daysChange in 02 flow rate delivered to the patient.
inpatient Pulmonary complication rates.throughout hospitalization an average of 5 daysPulmonary complications during hospitalization
Hospital discharge on O2.throughout hospitalization an average of 5 daysIf a study patient is discharged on 02.
Changes in Inspiratory volume.throughout hospitalization an average of 5 daysChanges (- or +) in the inspiratory volume a patient is able to achieve.
Change in Inspiratory volume.throughout hospitalization an average of 5 daysPostoperative change in inspiratory volume
Readmission for pulmonary complication30 days after dischargeReadmission for pulmonary complication up to 30 days after hospital discharge
Time to achieve goal tidal volume.throughout hospitalization an average of 5 daysTime in to achieve prescribed goal inspiratory tidal volume.
Post operative length of O2 use.throughout hospitalization an average of 5 daysLength of time from surgery until 02 is discontinued.

Other

MeasureTime frameDescription
Inpatient hospital length of staythroughout hospitalization an average of 5 daysPostoperative length of stay in hospital
Change in SP02throughout hospitalization an average of 5 daysPostoperative Change in SP02
Reintubation due to a respiratory diagnosisthroughout hospitalization an average of 5 daysReintubation due to a respiratory diagnosis during hospitalization
ICU length of staythroughout hospitalization an average of 5 daysPostoperative length of stay in ICU
Intubation due to a respiratory diagnosisthroughout hospitalization an average of 5 daysPostoperative Intubation due to a respiratory diagnosis during hospitalization

Countries

United States

Contacts

Primary ContactMichael Martin, RN
michael@tidalmed.tech18582121728
Backup ContactMehdi Arani
mehdi@tidalmed.tech

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026