Evaluating the Effectiveness of Incentive Spirometry

Study Overview
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Brief Summary
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Post-operative pulmonary complications (PPCs) have a major impact on patients and healthcare expenses. The goal of perioperative respiratory therapy is to improve airway clearance, increase lung volume, and mitigate atelectasis. Incentive spirometers (IS) are ubiquitously used to prevent atelectasis and PPCs-implementation of which requires substantial provider time and healthcare expenses. However, meta-analyses have demonstrated that the effectiveness of ISs is unclear due to poor patient compliance in past studies. The goal of this investigation is evaluate the effectiveness of IS on post-operative clinical outcomes. The aims of this investigation are to evaluate 1) if IS use compliance can be improved by adding a use-recording patient reminder alarm, and 2) the clinical outcomes of the more compliant IS users vs. the less-compliant IS users.

Official Title
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Evaluating the Effectiveness of Incentive Spirometry

Conditions
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Dyspnea, Respiratory Rate, Oxygen Saturation, Oxygen Requirements, FEV1, FVC, Atelectasis, Pneumonia, Re-intubation, Hospital Length of Stay, Nursing Workload, Incentive Spirometry

Intervention / Treatment
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* Behavioral: Use-recording, patient-reminder alarm for incentive spirometry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Undergoes any cardiothoracic surgery Is transferred to the cardiothoracic surgery intermediate (step-down) unit at Rhode Island Hospital Already prescribed an incentive spirometer as standard-of-care Followed by any healthcare provider Ability to sign informed consent and comply with all study procedures including follow-up for up to 1 year Exclusion Criteria: <18 years of age Vulnerable population who in the judgment of the investigator is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bell On<br>Subjects in the Bell On arm will receive a timer where the alarm will sound every hour. | Behavioral: Use-recording, patient-reminder alarm for incentive spirometry<br> <br> |
| Placebo Comparator: Bell Off<br>Subjects in the Bell Off arm will receive a timer where the alarm will not sound, but still record incentive spirometer usage | Behavioral: Use-recording, patient-reminder alarm for incentive spirometry<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance - Does the alarm improve IS use compliance? | The primary outcome will be to compare subjects' absolute IS usage count and hourly percent compliance in the Bell On arm vs the Bell Off arms. | up to 1 week postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcomes - Does IS use compliance improve clinical outcomes? | Subjective American Thoracic Society's Dyspnea Index43 - administered daily in ICTU ICTU Day 1: Baseline Dyspnea Index ICTU Day 2 through discharge: Transition Dyspnea Index Objective Trend during ICTU stay Vital signs (T, HR, RR, BP) O2 saturation Oxygen requirements CBC Bedside Pulmonary Function Tests (Micro 1, Carefusion) Daily FEV1, FVC, FEV6, PEF, FEV1/FVC, FEV1/FEV6 and F25-75 ratios. Wilcox atelectasis severity score44, 45 Scored 0-5 by daily chest x-ray Collaboration with Dr. Terrance Healy, Chief of Chest Radiology, RIH Pneumonia Rate of physician-diagnosed pneumonia Pneumonia severity index48 Length of ICTU stay Mortality In-hospital 30 day post-discharge 30-day readmission rates | up to 1 week postoperatively |