Comparing Use of Incentive Spirometry With and Without Reminder

Tidal Medical Technologies

Status

Enrolling

Conditions

Post Operative

Treatments

Device: Signal On

Study type

Observational

Funder types

Industry

Identifiers

NCT06101030

InSee 202301

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.