Warren Alpert Medical School of Brown University, Providence, Rhode Island.
Yale University School of Medicine, New Haven, Connecticut.
JAMA Surg. 2019 Jul 1;154(7):579-588. doi: 10.1001/jamasurg.2019.0520.
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).
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.
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.
激励型肺活量计(IS)旨在减少肺不张,并在临床广泛应用。然而,如果没有 IS 使用依从性数据,就无法确定 IS 的有效性。
评估使用跟踪型 IS 提醒对冠状动脉旁路移植术(CABG)后患者依从性和临床结果的影响。
设计、地点和参与者:这是一项随机临床试验,于 2017 年 6 月 5 日至 2017 年 12 月 29 日在一家三级转诊教学医院进行,共纳入 212 名接受 CABG 的患者,其中 160 名参与者(意向治疗)被随机分组,145 名按方案完成了研究。参与者根据手术紧急程度(择期与非择期)和性别(男性与女性)进行分层。
一种带有集成使用提醒铃的使用跟踪型、附加式 IS 设备(SpiroTimer)记录并标记参与者的吸气次数。患者被随机分配到每小时提醒“铃开”(实验组)或“铃关”(对照组)。
记录整个术后住院期间的激励型肺活量计使用情况,并比较两组之间的差异。放射学肺不张严重程度(评分 0-10)是主要的临床结局。还评估了呼吸和非呼吸相关的次要结局。
共评估了 145 名按方案完成研究的参与者(112 名男性[77%];平均年龄 69 岁[95%CI,67-70];90 名[62%]为非择期手术),其中 74 名(51.0%)在铃关组,71 名(49.0%)在铃开组。两组的基线医疗和康复动机特征相似。铃开组每日吸气次数较多(35 次;95%CI,29-43 比 17 次;95%CI,13-23;P<0.001)。铃开组记录的吸气事件时间百分比较高(58%;95%CI,51-65 比 28%;95%CI,23-32;P<0.001)。尽管首次术后胸部 X 线片的平均肺不张严重程度评分无差异(2.3;95%CI,2.0-2.6 比 2.4;95%CI,2.2-2.7;P=0.48),但铃开组在出院前最后一次胸部 X 线片的平均肺不张严重程度评分明显较低(1.5;95%CI,1.3-1.8 比 1.8;95%CI,1.6-2.1;P=0.04)。对于有术后早期发热的患者,铃开组的发热持续时间较短(3.2 小时;95%CI,2.3-4.6 比 5.2 小时;95%CI,3.9-7.0;P=0.04)。开启铃可降低非侵入性正压通气的使用率(37.2%;95%CI,24.1%-52.5%比 19.2%;95%CI,10.2%-33.0%;P=0.03),适用于接受非择期手术的患者。对于接受非择期手术的患者,铃开可缩短术后中位住院时间(7 天;95%CI,6-9 比 6 天;95%CI,6-7;P=0.048)和 ICU 住院时间(4 天;95%CI,3-5 比 3 天;95%CI,3-4;P=0.02)。6 个月时,非择期手术患者中铃关组的死亡率高于铃开组(9%比 0%,P=0.048)。
激励型肺活量计提醒可提高患者依从性、肺不张严重程度、术后早期发热持续时间、非侵入性正压通气使用、ICU 和住院时间,以及某些患者 6 个月的死亡率。使用提醒时,IS 似乎在适当使用时具有临床效果。
ClinicalTrials.gov 标识符:NCT02952027。