一种新型膈肌移动度测量方法的验证研究:经相控阵探头评估肝肾及脾肾切面膈肌移动度

Validation study of a novel diaphragmatic excursion measurement method:evaluation of diaphragmatic excursion by phased-array probe in hepato-renal/spleno-renal section

目的探讨使用经肝肾/脾肾切面超声测量膈肌移动度(DE)作为评估膈肌功能新方法的准确性及可重复性。方法通过招募方式纳入12名健康受试者。每位受试者均由4名不同经验水平的操作者分别采用传统方法(肝下/脾下切面)和新方法(肝肾/脾肾切面)测量DE,其中2名有经验的操作者为重症临床医师,膈肌超声操作大于50例;另外2名无经验的操作者为呼吸治疗师,膈肌超声操作小于10例,均接受2 h理论及操作培训,考核通过后再开始试验操作。操作者首先应用传统方法,采用1.5~6.0 MHz凸阵探头,选择M超模式,将取样线垂直于膈肌置于移动度最大处,于受试者平静呼吸时测量肝下/脾下切面DE;然后应用新型测量方法,采用1.6~4.5 MHz相控阵探头,经腋中线观察膈肌沿头尾方向的移动情况,选择解剖M超模式,将取样线垂直于膈肌置于肾脏中点水平,于受试者平静呼吸时测量肝肾/脾肾切面DE。肝下及肝肾切面用于评估右侧膈肌,脾下及脾肾切面用于评估左侧膈肌。采用Deming法对不同切面测量的DE进行相关性分析;采用Bland-Altman法进行一致性分析,临床可接受的一致性界限定义为不存在固定偏倚和比例偏倚,且测量值之间差异的2个标准差小于测量值平均值的40%,即%一致性界限=测量值之间差异的2个标准差/测量值平均值×100%。结果4名操作者分别对12名受试者进行4个切面DE的图像扫查,其中肝肾切面及脾肾切面DE获取率均高达100%(48/48),肝下切面次之〔91.7%(44/48)〕,脾下切面最低〔66.7%(32/48)〕,提示对于左侧膈肌的评估,脾肾切面DE获取率显著高于传统脾下切面(P<0.01)。总体测量结果显示,新方法经肝肾切面与脾肾切面测量的DE差异无统计学意义(cm:1.64±0.10比1.55±0.14,P>0.05),且均显著高于传统方法经肝下切面和脾下切面测量的DE(cm:肝肾切面比肝下切面为1.64±0.10比1.44±0.09,脾肾切面比脾下切面为1.55±0.14比1.09±0.14,均P<0.01)。相关性分析显示,肝肾切面与脾肾切面、肝下切面与肝肾切面、肝下切面与脾肾切面测量的DE均具有较好的相关性(r值分别为0.62、0.59、0.42,均P<0.01);一致性分析显示,肝肾切面与脾肾切面、肝下切面与肝肾切面测量的DE一致性均较好(%一致性界限均<40%),而脾下切面与其他3个切面测量的DE均不相关,且不存在一致性(%一致性界限均>40%)。4名操作者在肝下切面、脾下切面、肝肾切面和脾肾切面测量的DE差异均无统计学意义(cm:肝下切面分别为1.49±0.34、1.44±0.37、1.43±0.30、1.40±0.27,脾下切面分别为1.10±0.36、1.05±0.18、1.09±0.22、1.06±0.26,肝肾切面分别为1.67±0.43、1.57±0.34、1.63±0.32、1.66±0.36,脾肾切面分别为1.45±0.33、1.48±0.34、1.50±0.24、1.65±0.26,均P>0.05);根据临床可接受的一致性界限范围,4名操作者在4个切面测量的DE一致性均较好(%一致性界限均<40%)。结论经肝肾/脾肾切面测量DE是一种准确、可重复性好、获取率高的新方法,可作为传统经肝下/脾下切面测量DE的替代方法。

Objective To investigate the accuracy and reproducibility of diaphragmatic excursion(DE)measurements through hepato-renal/spleno-renal section as a novel method for assessing diaphragmatic function.Methods Twelve healthy participants were recruited.Each participant underwent DE measurements performed by four operators with varying levels of experience using traditional methods(liver/spleen section)and novel methods(hepato-renal/spleno-renal section),respectively.Among them,two experienced operators were critical care clinicians,and diaphragmatic ultrasound was performed in more than 50 cases.The other two inexperienced operators were respiratory therapists,with less than 10 cases of diaphragmatic ultrasound operations,who received a 2-hour theoretical and operational training before the study.Operators initially used the conventional method with a 1.5-6.0 MHz convex probe in M-mode,placing the sampling line perpendicular to the diaphragm at the point of maximum excursion,and the liver/spleen section DE was determined during normal breathing of participant.Then,they used the novel method with a 1.6-4.5 MHz phased array probe to observe diaphragmatic movement cranio-caudally along the mid-axillary line,employing anatomic M-mode with the sampling line placed perpendicular to the diaphragm at the level of the renal midpoint,and the DE of the hepato-renal/spleno-renal section was measured during normal breathing.The liver and hepato-renal sections were used to assess the right diaphragm,and spleen and spleno-renal sections were used to assess the left diaphragm.Correlation analysis of DE measurements from different sections was conducted using the Deming method,while consistency was assessed using the Bland-Altman method.The consistency of clinical acceptability was defined as the absence of fixed and proportional bias,with a difference of two standard deviations less than 40%of the mean measurement value.Percentage consistency limit=two standard deviations of the differences between measurements/mean measurement value×100%.Results Four operators performed image scans of DE in all four sections for each of the twelve subjects,with a high DE acquisition rate of 100%(48/48)for hepato-renal and spleno-renal sections,followed by the liver section[91.7%(44/48)]and the spleen section[66.7%(32/48)],particularly for the left diaphragm assessment,where the DE acquisition rate of spleno-renal section was significantly higher than that of traditional spleen section(P<0.01).The overall measurement results showed that no significant difference was found in DE determined via the hepato-renal and spleno-renal sections using the novel method(cm:1.64±0.10 vs.1.55±0.14,P>0.05),and they were significantly higher than those determined via the conventional liver and spleen sections(cm:hepato-renal section vs.liver section was 1.64±0.10 vs.1.44±0.09,spleno-renal section vs.spleen section was 1.55±0.14 vs.1.09±0.14,both P<0.01).Correlation analysis revealed good correlations of DE between hepato-renal section and spleno-renal section,between liver section and hepato-renal section,between liver section and spleno-renal section(r values were 0.62,0.59,and 0.42,all P<0.01).Consistency analysis showed that the consistency in DE between hepato-renal section and spleno-renal section,as well as between liver section and hepato-renal section was good(both%consistency limits<40%).However,the DE measured in the spleen section were not correlated with the other three sections,and there was no inconsistency(all%consistency limits>40%).There was no statistically significant difference in DE measured by the four operators in the liver,spleen,hepato-renal,and spleno-renal sections(cm:1.49±0.34,1.44±0.37,1.43±0.30,and 1.40±0.27 in liver section;1.10±0.36,1.05±0.18,1.09±0.22,and 1.06±0.26 in spleen section;1.67±0.43,1.57±0.34,1.63±0.32,and 1.66±0.36 in hepato-renal section;1.45±0.33,1.48±0.34,1.50±0.24,and 1.65±0.26 in spleno-renal section;all P>0.05).According to the clinically acceptable range of consistency limits,the DE measured by the four operators in all four sections showed good consistency(all%consistency limits<40%).Conclusion The novel method of measuring DE through hepato-renal/spleno-renal sections is accurate,highly reproducible,and has a high acquisition rate,serving as a viable alternative to the conventional method involving the liver/spleen section.