Effect of an Incentive Spirometer Patient Reminder After Coronary Artery Bypass Grafting: A Randomized Clinical Trial

IMPORTANCE: 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. OBJECTIVE: To evaluate the effect of a use-tracking IS reminder on patient adherence and clinical out...

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Veröffentlicht in:Archives of surgery (Chicago. 1960) 2019-07, Vol.154 (7), p.579-588
Hauptverfasser: Eltorai, Adam E. M, Baird, Grayson L, Eltorai, Ashley Szabo, Healey, Terrance T, Agarwal, Saurabh, Ventetuolo, Corey E, Martin, Thomas J, Chen, Jane, Kazemi, Layla, Keable, Catherine A, Diaz, Emily, Pangborn, Joshua, Fox, Jordan, Connors, Kevin, Sellke, Frank W, Elias, Jack A, Daniels, Alan H
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container_end_page 588
container_issue 7
container_start_page 579
container_title Archives of surgery (Chicago. 1960)
container_volume 154
creator Eltorai, Adam E. M
Baird, Grayson L
Eltorai, Ashley Szabo
Healey, Terrance T
Agarwal, Saurabh
Ventetuolo, Corey E
Martin, Thomas J
Chen, Jane
Kazemi, Layla
Keable, Catherine A
Diaz, Emily
Pangborn, Joshua
Fox, Jordan
Connors, Kevin
Sellke, Frank W
Elias, Jack A
Daniels, Alan H
description IMPORTANCE: 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. OBJECTIVE: 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). INTERVENTIONS: 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. RESULTS: 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 
doi_str_mv 10.1001/jamasurg.2019.0520
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M ; Baird, Grayson L ; Eltorai, Ashley Szabo ; Healey, Terrance T ; Agarwal, Saurabh ; Ventetuolo, Corey E ; Martin, Thomas J ; Chen, Jane ; Kazemi, Layla ; Keable, Catherine A ; Diaz, Emily ; Pangborn, Joshua ; Fox, Jordan ; Connors, Kevin ; Sellke, Frank W ; Elias, Jack A ; Daniels, Alan H</creator><creatorcontrib>Eltorai, Adam E. M ; Baird, Grayson L ; Eltorai, Ashley Szabo ; Healey, Terrance T ; Agarwal, Saurabh ; Ventetuolo, Corey E ; Martin, Thomas J ; Chen, Jane ; Kazemi, Layla ; Keable, Catherine A ; Diaz, Emily ; Pangborn, Joshua ; Fox, Jordan ; Connors, Kevin ; Sellke, Frank W ; Elias, Jack A ; Daniels, Alan H</creatorcontrib><description>IMPORTANCE: 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. OBJECTIVE: 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). INTERVENTIONS: 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. RESULTS: 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 &lt; .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 &lt; .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. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02952027</description><identifier>ISSN: 2168-6254</identifier><identifier>EISSN: 2168-6262</identifier><identifier>DOI: 10.1001/jamasurg.2019.0520</identifier><identifier>PMID: 30969332</identifier><language>eng</language><publisher>United States: American Medical Association</publisher><subject>Aged ; Clinical trials ; Coronary Artery Bypass - adverse effects ; Coronary Artery Disease - surgery ; Female ; Follow-Up Studies ; Heart surgery ; Humans ; Incidence ; Intensive Care Units ; Male ; Online First ; Original Investigation ; Patient Compliance ; Postoperative Complications - diagnosis ; Postoperative Complications - epidemiology ; Postoperative Complications - prevention &amp; control ; Pulmonary Atelectasis - diagnosis ; Pulmonary Atelectasis - epidemiology ; Pulmonary Atelectasis - prevention &amp; control ; Radiography ; Retrospective Studies ; Spirometry - methods ; Survival Rate - trends ; United States - epidemiology</subject><ispartof>Archives of surgery (Chicago. 1960), 2019-07, Vol.154 (7), p.579-588</ispartof><rights>Copyright American Medical Association Jul 2019</rights><rights>Copyright 2019 American Medical Association. All Rights Reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-a356t-46188c166d969d4a381836163bbfdaf1dee668cb9b544d7ac81a3ab81d1e89063</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://jamanetwork.com/journals/jamasurgery/articlepdf/10.1001/jamasurg.2019.0520$$EPDF$$P50$$Gama$$H</linktopdf><linktohtml>$$Uhttps://jamanetwork.com/journals/jamasurgery/fullarticle/10.1001/jamasurg.2019.0520$$EHTML$$P50$$Gama$$H</linktohtml><link.rule.ids>64,230,314,776,780,881,3326,27903,27904,76236,76239</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30969332$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Eltorai, Adam E. M</creatorcontrib><creatorcontrib>Baird, Grayson L</creatorcontrib><creatorcontrib>Eltorai, Ashley Szabo</creatorcontrib><creatorcontrib>Healey, Terrance T</creatorcontrib><creatorcontrib>Agarwal, Saurabh</creatorcontrib><creatorcontrib>Ventetuolo, Corey E</creatorcontrib><creatorcontrib>Martin, Thomas J</creatorcontrib><creatorcontrib>Chen, Jane</creatorcontrib><creatorcontrib>Kazemi, Layla</creatorcontrib><creatorcontrib>Keable, Catherine A</creatorcontrib><creatorcontrib>Diaz, Emily</creatorcontrib><creatorcontrib>Pangborn, Joshua</creatorcontrib><creatorcontrib>Fox, Jordan</creatorcontrib><creatorcontrib>Connors, Kevin</creatorcontrib><creatorcontrib>Sellke, Frank W</creatorcontrib><creatorcontrib>Elias, Jack A</creatorcontrib><creatorcontrib>Daniels, Alan H</creatorcontrib><title>Effect of an Incentive Spirometer Patient Reminder After Coronary Artery Bypass Grafting: A Randomized Clinical Trial</title><title>Archives of surgery (Chicago. 1960)</title><addtitle>JAMA Surg</addtitle><description>IMPORTANCE: 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. OBJECTIVE: 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). INTERVENTIONS: 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. RESULTS: 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 &lt; .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 &lt; .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. 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M ; Baird, Grayson L ; Eltorai, Ashley Szabo ; Healey, Terrance T ; Agarwal, Saurabh ; Ventetuolo, Corey E ; Martin, Thomas J ; Chen, Jane ; Kazemi, Layla ; Keable, Catherine A ; Diaz, Emily ; Pangborn, Joshua ; Fox, Jordan ; Connors, Kevin ; Sellke, Frank W ; Elias, Jack A ; Daniels, Alan H</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-a356t-46188c166d969d4a381836163bbfdaf1dee668cb9b544d7ac81a3ab81d1e89063</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Aged</topic><topic>Clinical trials</topic><topic>Coronary Artery Bypass - adverse effects</topic><topic>Coronary Artery Disease - surgery</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Heart surgery</topic><topic>Humans</topic><topic>Incidence</topic><topic>Intensive Care Units</topic><topic>Male</topic><topic>Online First</topic><topic>Original Investigation</topic><topic>Patient Compliance</topic><topic>Postoperative Complications - diagnosis</topic><topic>Postoperative Complications - epidemiology</topic><topic>Postoperative Complications - prevention &amp; control</topic><topic>Pulmonary Atelectasis - diagnosis</topic><topic>Pulmonary Atelectasis - epidemiology</topic><topic>Pulmonary Atelectasis - prevention &amp; control</topic><topic>Radiography</topic><topic>Retrospective Studies</topic><topic>Spirometry - methods</topic><topic>Survival Rate - trends</topic><topic>United States - epidemiology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Eltorai, Adam E. 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M</au><au>Baird, Grayson L</au><au>Eltorai, Ashley Szabo</au><au>Healey, Terrance T</au><au>Agarwal, Saurabh</au><au>Ventetuolo, Corey E</au><au>Martin, Thomas J</au><au>Chen, Jane</au><au>Kazemi, Layla</au><au>Keable, Catherine A</au><au>Diaz, Emily</au><au>Pangborn, Joshua</au><au>Fox, Jordan</au><au>Connors, Kevin</au><au>Sellke, Frank W</au><au>Elias, Jack A</au><au>Daniels, Alan H</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effect of an Incentive Spirometer Patient Reminder After Coronary Artery Bypass Grafting: A Randomized Clinical Trial</atitle><jtitle>Archives of surgery (Chicago. 1960)</jtitle><addtitle>JAMA Surg</addtitle><date>2019-07-01</date><risdate>2019</risdate><volume>154</volume><issue>7</issue><spage>579</spage><epage>588</epage><pages>579-588</pages><issn>2168-6254</issn><eissn>2168-6262</eissn><abstract>IMPORTANCE: 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. OBJECTIVE: 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). INTERVENTIONS: 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. RESULTS: 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 &lt; .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 &lt; .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. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02952027</abstract><cop>United States</cop><pub>American Medical Association</pub><pmid>30969332</pmid><doi>10.1001/jamasurg.2019.0520</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record>
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subjects Aged
Clinical trials
Coronary Artery Bypass - adverse effects
Coronary Artery Disease - surgery
Female
Follow-Up Studies
Heart surgery
Humans
Incidence
Intensive Care Units
Male
Online First
Original Investigation
Patient Compliance
Postoperative Complications - diagnosis
Postoperative Complications - epidemiology
Postoperative Complications - prevention & control
Pulmonary Atelectasis - diagnosis
Pulmonary Atelectasis - epidemiology
Pulmonary Atelectasis - prevention & control
Radiography
Retrospective Studies
Spirometry - methods
Survival Rate - trends
United States - epidemiology
title Effect of an Incentive Spirometer Patient Reminder After Coronary Artery Bypass Grafting: A Randomized Clinical Trial
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