Comparing Use of Incentive Spirometry With and Without Reminder

NCT06101030 | Recruiting FDA Device

• 1 other identifier: InSee 202301
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 3

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.

Conditions

Post Operative

Keywords

Incentive spirometry; Post Operative; compliance

Outcome Measures

Primary Outcomes (2)

• Number of successful inspiratory breaths attempts per day.

  successful inspiratory breaths is defined as achieving the goal tidal volume

  through hospitalization an average of 5 days

• Total number of inspiratory breaths achieved per day.

  Inspiratory breaths while using the incentive spirometer

  throughout hospitalization an average of 5 days

Secondary Outcomes (8)

• Time to achieve goal tidal volume.

  throughout hospitalization an average of 5 days

• Post operative length of O2 use.

  throughout hospitalization an average of 5 days

• Change in 02 flow rate.

  throughout hospitalization an average of 5 days

• inpatient Pulmonary complication rates.

  throughout hospitalization an average of 5 days

• Hospital discharge on O2.

  throughout hospitalization an average of 5 days

Other Outcomes (5)

• Intubation due to a respiratory diagnosis

  throughout hospitalization an average of 5 days

• Reintubation due to a respiratory diagnosis

  throughout hospitalization an average of 5 days

• ICU length of stay

  throughout hospitalization an average of 5 days

Study Arms (2)

Signal On

Patient Signals ON

Device: Signal On

Signal Off

Patient Signals Off

Interventions

Signal On DEVICE

InSee monitor patient signals are on.

Signal On

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Post Operative Inpatients prescribed incentive spirometry.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tidal Medical Technologies: lead

Study Sites (3)

Tidal Reseach Site

Silver Spring, Maryland, 20904, United States

TERMINATED

Tidal Study Site

Rochester, Minnesota, 55905, United States

RECRUITING

Tidal Study Site

New Brunswick, New Jersey, 08901, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 29362219 BACKGROUND

• 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.

  PMID: 34429138 BACKGROUND

• 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.

  PMID: 34676618 BACKGROUND

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Hassan Study Director, M.D.

  Tidal Medical Technologies

  STUDY DIRECTOR

Central Study Contacts

Michael Martin, RN

CONTACT

18582121728; michael@tidalmed.tech

Mehdi Arani

CONTACT

mehdi@tidalmed.tech

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 25, 2023
• Study Start: January 16, 2024
• Primary Completion: September 3, 2025
• Study Completion: September 7, 2025
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)