Comparing Use of Incentive Spirometry With and Without Reminder

NCT ID: NCT06101030

Last Updated: 2025-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-16

Study Completion Date

2025-09-07

Brief Summary

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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

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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.

Conditions

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Post Operative

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Signal On

Patient Signals ON

Signal On

Intervention Type DEVICE

InSee monitor patient signals are on.

Signal Off

Patient Signals Off

No interventions assigned to this group

Interventions

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Signal On

InSee monitor patient signals are on.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tidal Medical Technologies

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hassan Study Director, M.D.

Role: STUDY_DIRECTOR

Tidal Medical Technologies

Locations

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Tidal Reseach Site

Silver Spring, Maryland, United States

Site Status TERMINATED

Tidal Study Site

Rochester, Minnesota, United States

Site Status RECRUITING

Tidal Study Site

New Brunswick, New Jersey, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Michael Martin, RN

Role: CONTACT

18582121728

Mehdi Arani

Role: CONTACT

Facility Contacts

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William LeTourneau

Role: primary

Brian Raffel, DO

Role: primary

References

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Eltorai AEM, Baird GL, Eltorai AS, Pangborn J, Antoci V Jr, Cullen HA, Paquette K, Connors K, Barbaria J, Smeals KJ, Agarwal S, Healey TT, Ventetuolo CE, Sellke FW, Daniels AH. Incentive Spirometry Adherence: A National Survey of Provider Perspectives. Respir Care. 2018 May;63(5):532-537. doi: 10.4187/respcare.05882. Epub 2018 Jan 23.

Reference Type BACKGROUND
PMID: 29362219 (View on PubMed)

Sweity EM, Alkaissi AA, Othman W, Salahat A. Preoperative incentive spirometry for preventing postoperative pulmonary complications in patients undergoing coronary artery bypass graft surgery: a prospective, randomized controlled trial. J Cardiothorac Surg. 2021 Aug 24;16(1):241. doi: 10.1186/s13019-021-01628-2.

Reference Type BACKGROUND
PMID: 34429138 (View on PubMed)

Alwekhyan SA, Alshraideh JA, Yousef KM, Hayajneh F. Nurse-guided incentive spirometry use and postoperative pulmonary complications among cardiac surgery patients: A randomized controlled trial. Int J Nurs Pract. 2022 Apr;28(2):e13023. doi: 10.1111/ijn.13023. Epub 2021 Oct 22.

Reference Type BACKGROUND
PMID: 34676618 (View on PubMed)

Other Identifiers

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InSee 202301

Identifier Type: -

Identifier Source: org_study_id

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