Clinical trial NCT06101030: Comparing Use of Incentive Spirometry With and Without Reminder
Official title: Comparing Post Operative Utilization of Incentive Spirometry With and Without Electronic Patient Reminder
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Post Operative
Keywords: Incentive spirometry
Post Operative
compliance
Lead sponsor: Tidal Medical Technologies
Sponsor class: INDUSTRY
First posted: 2023-10-25
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Post Operative Inpatients prescribed incentive spirometry.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of successful inspiratory breaths attempts per day.
timeFrame: through hospitalization an average of 5 days
measure: Total number of inspiratory breaths achieved per day.
timeFrame: throughout hospitalization an average of 5 days
Secondary outcomes:
measure: Time to achieve goal tidal volume.
timeFrame: throughout hospitalization an average of 5 days
measure: Post operative length of O2 use.
timeFrame: throughout hospitalization an average of 5 days
measure: Change in 02 flow rate.
timeFrame: throughout hospitalization an average of 5 days
measure: inpatient Pulmonary complication rates.
timeFrame: throughout hospitalization an average of 5 days
measure: Hospital discharge on O2.
timeFrame: throughout hospitalization an average of 5 days
measure: Changes in Inspiratory volume.
timeFrame: throughout hospitalization an average of 5 days
measure: Change in Inspiratory volume.
timeFrame: throughout hospitalization an average of 5 days
measure: Readmission for pulmonary complication
timeFrame: 30 days after discharge
Other outcomes:
measure: Intubation due to a respiratory diagnosis
timeFrame: throughout hospitalization an average of 5 days
measure: Reintubation due to a respiratory diagnosis
timeFrame: throughout hospitalization an average of 5 days
measure: ICU length of stay
timeFrame: throughout hospitalization an average of 5 days
measure: Inpatient hospital length of stay
timeFrame: throughout hospitalization an average of 5 days
measure: Change in SP02
timeFrame: throughout hospitalization an average of 5 days
Locations:
city: Silver Spring
country: United States
facility: Tidal Reseach Site
state: Maryland
city: Rochester
country: United States
facility: Tidal Study Site
state: Minnesota
city: New Brunswick
country: United States
facility: Tidal Study Site
state: New Jersey
Study officials:
affiliation: Tidal Medical Technologies
name: Hassan Study Director, M.D.
role: STUDY_DIRECTOR
References:
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.
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.
citation: 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.