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What is the effect of a use-tracking incentive spirometer (IS) reminder on patient adherence and clinical outcomes following coronary artery bypass grafting surgery?
In this randomized clinical trial that included 160 patients undergoing coronary artery bypass grafting, the patient reminder improved IS use adherence, atelectasis severity, early postoperative fevers, noninvasive positive pressure ventilation use, intensive care unit length of stay by a day, and 6-month mortality rates.
With the reminder, IS appears to be clinically effective when used appropriately.
Incentive spirometers (ISs) were developed to reduce atelectasis and are in widespread clinical use. However, without IS use adherence data, the effectiveness of IS cannot be determined.
To evaluate the effect of a use-tracking IS reminder on patient adherence and clinical outcomes following coronary artery bypass grafting (CABG) surgery.
Design, Setting, and Participants
This randomized clinical trial was conducted from June 5, 2017, to December 29, 2017, at a tertiary referral teaching hospital and included 212 patients who underwent CABG, of whom 160 participants were randomized (intent to treat), with 145 completing the study per protocol. Participants were stratified by surgical urgency (elective vs nonelective) and sex (men vs women).
A use-tracking, IS add-on device (SpiroTimer) with an integrated use reminder bell recorded and timestamped participants’ inspiratory breaths. Patients were randomized by hourly reminder “bell on” (experimental group) or “bell off” (control group).
Main Outcomes and Measures
Incentive spirometer use was recorded for the entire postoperative stay and compared between groups. Radiographic atelectasis severity (score, 0-10) was the primary clinical outcome. Secondary respiratory and nonrespiratory outcomes were also evaluated.
A total of 145 per-protocol participants (112 men [77%]; mean age, 69 years [95% CI, 67-70]; 90 [62%] undergoing a nonelective procedure) were evaluated, with 74 (51.0%) in the bell off group and 71 (49.0%) in the bell on group. The baseline medical and motivation-to-recover characteristics of the 2 groups were similar. The mean number of daily inspiratory breaths was greater in bell on (35; 95% CI, 29-43 vs 17; 95% CI, 13-23; P < .001). The percentage of recorded hours with an inspiratory breath event was greater in bell on (58%; 95% CI, 51-65 vs 28%; 95% CI, 23-32; P < .001). Despite no differences in the first postoperative chest radiograph mean atelectasis severity scores (2.3; 95% CI, 2.0-2.6 vs 2.4; 95% CI, 2.2-2.7; P = .48), the mean atelectasis severity scores for the final chest radiographs conducted before discharge were significantly lower for bell on than bell off group (1.5; 95% CI, 1.3-1.8 vs 1.8; 95% CI, 1.6-2.1; P = .04). Of those with early postoperative fevers, fever duration was shorter for bell on (3.2 hours; 95% CI, 2.3-4.6 vs 5.2 hours; 95% CI, 3.9-7.0; P = .04). Having the bell turned on reduced noninvasive positive pressure ventilation use rates (37.2%; 95% CI, 24.1%-52.5% vs 19.2%; 95% CI, 10.2%-33.0%; P = .03) for participants undergoing nonelective procedures. Bell on reduced the median postoperative length of stay (7 days; 95% CI, 6-9 vs 6 days; 95% CI, 6-7; P = .048) and the intensive care unit length of stay for patients undergoing nonelective procedures (4 days; 95% CI, 3-5 vs 3 days; 95% CI, 3-4; P = .02). At 6 months, the bell off mortality rate was higher than bell on (9% vs 0%, P = .048) for participants undergoing nonelective procedures.
Conclusions and Relevance
The incentive spirometer reminder improved patient adherence, atelectasis severity, early postoperative fever duration, noninvasive positive pressure ventilation use, ICU and length of stay, and 6-month mortality in certain patients. With the reminder, IS appears to be clinically effective when used appropriately.
ClinicalTrials.gov identifier: NCT02952027
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Accepted for Publication: February 10, 2019.
Corresponding Author: Adam E. M. Eltorai, PhD, Warren Alpert Medical School, Brown University, 222 Richmond St, Providence, RI 02903 (firstname.lastname@example.org).
Published Online: April 10, 2019. doi:10.1001/jamasurg.2019.0520
Author Contributions: Drs A. E. M. Eltorai and Baird had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: A. E. M. Eltorai, Baird, A. S. Eltorai, Agarwal, Ventetuolo, Connors, Sellke, Elias, Daniels.
Acquisition, analysis, or interpretation of data: A. E. M. Eltorai, Baird, Healey, Agarwal, Martin, Chen, Kazemi, Keable, Diaz Santos, Pangborn, Fox, Sellke, Daniels.
Drafting of the manuscript: A. E. M. Eltorai, Baird, Keable, Elias, Daniels.
Critical revision of the manuscript for important intellectual content: A. E. M. Eltorai, Baird, A. S. Eltorai, Healey, Agarwal, Ventetuolo, Martin, Chen, Kazemi, Diaz Santos, Pangborn, Fox, Connors, Sellke, Elias, Daniels.
Statistical analysis: A. E. Eltorai, Baird.
Obtained funding: Daniels.
Administrative, technical, or material support: A. E. M. Eltorai, A. S. Eltorai, Healey, Martin, Kazemi, Diaz Santos, Pangborn, Connors, Sellke, Elias, Daniels.
Supervision: A. E. M. Eltorai, Healey, Agarwal, Connors, Sellke, Elias, Daniels.
Other - Obtained data: Keable.
Conflict of Interest Disclosures: Dr A. E. M. Eltorai receives book editor royalties from Springer and Lippincott; owns equity in Quitbit, Inc; and is listed as an inventor on the patent application “Patient Reminder System and Method for Incentive Spirometer Utilization” (US Application US20180000379A1), from which he has received no money or financial benefit from the patent application. Dr Daniels is a consultant for DePuy, Globus Medical, Orthofix, and Stryker and he received book editor royalties from Springer. Dr Sellke reports receiving consulting fees from Stryker and Boehringer Ingelheim. No other disclosures were reported.
Data Sharing Statement: See Supplement 3.
Additional Contributions: We thank the following uncompensated individuals for their help with data collection: Steven E. Reinert, MS, Lifespan Information Services; Kimberly J. Smeals, RRT, and Jaqueline Barbaria, RRT, Rhode Island Hospital Respiratory Therapy; Ankush Bajaj, BA, Brown University; Laura Norton, RN, Lifespan; Jeffrey Karg, MS, Boston Innovation; Renee David, MS, RNP, Rhode Island Hospital Cardiac Surgery; and Paula Gellner, MSN, and Samantha Moylan, BSN, RN, Rhode Island Hospital.
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