Comparing Use of Incentive Spirometry With and Without Reminder

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

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.

Study Overview

• Status: Recruiting
• Conditions: Post Operative
• Intervention / Treatment: Device: Signal On

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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Michael Martin, RN; Phone Number: 18582121728; Email: michael@tidalmed.tech
• Study Contact Backup: Name: Mehdi Arani; Email: mehdi@tidalmed.tech

Study Locations

• United States
  • Maryland
    • Silver Spring, Maryland, United States, 20904
      • Recruiting
      • Tidal Reseach Site
      • Contact: Jennifer Hernandez, RN; Phone Number: 240-637-5024
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Not yet recruiting
      • Tidal Study Site
      • Contact: William LeTourneau
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Recruiting
      • Tidal Study Site
      • Contact: Brian Raffel, DO
  • Texas
    • Galveston, Texas, United States, 77555
      • Not yet recruiting
      • Tidal Study Site
      • Contact: Brian Walsh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Post Operative Inpatients prescribed incentive spirometry.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Signal On; Patient Signals ON	Device: Signal On; InSee monitor patient signals are on.
Signal Off; Patient Signals Off

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intubation due to a respiratory diagnosis	Postoperative Intubation due to a respiratory diagnosis during hospitalization	throughout hospitalization an average of 5 days
Reintubation due to a respiratory diagnosis	Reintubation due to a respiratory diagnosis during hospitalization	throughout hospitalization an average of 5 days
ICU length of stay	Postoperative length of stay in ICU	throughout hospitalization an average of 5 days
Inpatient hospital length of stay	Postoperative length of stay in hospital	throughout hospitalization an average of 5 days
Change in SP02	Postoperative Change in SP02	throughout hospitalization an average of 5 days

Collaborators and Investigators

• Sponsor: Tidal Medical Technologies
• Investigators: Study Director: Hasan Kakli, MD, Tidal Medical Technologies

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2024
• Primary Completion (Estimated): June 3, 2024
• Study Completion (Estimated): July 7, 2024

Study Registration Dates

• First Submitted: October 18, 2023
• First Submitted That Met QC Criteria: October 23, 2023
• First Posted (Actual): October 25, 2023

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: compliance; Post Operative; Incentive spirometry
• Other Study ID Numbers: InSee 202301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No