Comparing Use of Incentive Spirometry With and Without Reminder

Post Operative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06101030
• Other study ID #: InSee 202301
• Status: Recruiting
• Start date: January 16, 2024
• Est. completion date: July 7, 2024

Study information

• Verified date: March 2024
• Source: Tidal Medical Technologies
• Contact: Michael Martin, RN
• Phone: 18582121728
• Email: michael[@]tidalmed.tech
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 7, 2024
• Est. primary completion date: June 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Post Operative

Intervention

Device:
• Signal On
InSee monitor patient signals are on.

Locations

Country	Name	City	State
United States	Tidal Study Site	Galveston	Texas
United States	Tidal Study Site	New Brunswick	New Jersey
United States	Tidal Study Site	Rochester	Minnesota
United States	Tidal Reseach Site	Silver Spring	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Tidal Medical Technologies

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intubation due to a respiratory diagnosis	Postoperative Intubation due to a respiratory diagnosis during hospitalization	throughout hospitalization an average of 5 days
Other	Reintubation due to a respiratory diagnosis	Reintubation due to a respiratory diagnosis during hospitalization	throughout hospitalization an average of 5 days
Other	ICU length of stay	Postoperative length of stay in ICU	throughout hospitalization an average of 5 days
Other	Inpatient hospital length of stay	Postoperative length of stay in hospital	throughout hospitalization an average of 5 days
Other	Change in SP02	Postoperative Change in SP02	throughout hospitalization an average of 5 days
Primary	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
Primary	Total number of inspiratory breaths achieved per day.	Inspiratory breaths while using the incentive spirometer	throughout hospitalization an average of 5 days
Secondary	Time to achieve goal tidal volume.	Time in to achieve prescribed goal inspiratory tidal volume.	throughout hospitalization an average of 5 days
Secondary	Post operative length of O2 use.	Length of time from surgery until 02 is discontinued.	throughout hospitalization an average of 5 days
Secondary	Change in 02 flow rate.	Change in 02 flow rate delivered to the patient.	throughout hospitalization an average of 5 days
Secondary	inpatient Pulmonary complication rates.	Pulmonary complications during hospitalization	throughout hospitalization an average of 5 days
Secondary	Hospital discharge on O2.	If a study patient is discharged on 02.	throughout hospitalization an average of 5 days
Secondary	Changes in Inspiratory volume.	Changes (- or +) in the inspiratory volume a patient is able to achieve.	throughout hospitalization an average of 5 days
Secondary	Change in Inspiratory volume.	Postoperative change in inspiratory volume	throughout hospitalization an average of 5 days
Secondary	Readmission for pulmonary complication	Readmission for pulmonary complication up to 30 days after hospital discharge	30 days after discharge