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Intensive Care Med (2007) 33:1191–1194 DOI 10.

1007/s00134-007-0640-0

BRIEF REPORT

Pierre Squara Dominique Denjean Philippe Estagnasie Alain Brusset Jean Claude Dib Claude Dubois

Noninvasive cardiac output monitoring (NICOM): a clinical validation

Received: 13 June 2006 Accepted: 26 March 2007 Published online: 26 April 2007 © Springer-Verlag 2007 Electronic supplementary material The online version of this article (doi:10.1007/s00134-007-0640-0) contains supplementary material, which is available to authorized users. Support: This study was supported by a grant from Cheetah Med. Inc., Wilmington, DE, USA.

P. Squara (u) · D. Denjean · P. Estagnasie · A. Brusset · J. C. Dib · C. Dubois Clinique Ambroise Paré, CERIC, 27, boulevard Victor Hugo, 92200 Neuilly-sur-Seine, France e-mail: pierre.squara@wanadoo.fr Tel.: +33 1-46418971 Fax: +33-1-46418981

Abstract Objective: To evaluate the clinical utility of a new device for continuous noninvasive cardiac output monitoring (NICOM) based on chest bio-reactance compared with cardiac output measured semicontinuously by thermodilution using a pulmonary artery catheter (PAC-CCO). Design: Prospective, single-center study. Setting: Intensive care unit. Patients: Consecutive adult patients immediately after cardiac surgery. Interventions: Cardiac output measurements obtained from NICOM and thermodilution were simultaneously recorded minute by minute and compared in 110 patients. We evaluated the accuracy, precision, responsiveness, and reliability of NICOM for detecting cardiac output changes. Tolerance for each of these parameters was specified prospectively. Measurements and results: A total of 65,888 pairs of cardiac output measurements were collected. Mean reference values for cardiac output ranged from 2.79 to 9.27 l/min. During periods of stable PAC-CCO

(slope < ± 10%, 2SD/mean < 20%), the correlation between NICOM and thermodilution was R = 0.82; bias was +0.16 ± 0.52 l/min (+4.0 ± 11.3%), and relative error was 9.1% ± 7.8%. In 85% of patients the relative error was < 20%. During periods of increasing output, slopes were similar with the two methods in 96% of patients and intra-class correlation was positive in 96%. Corresponding values during periods of decreasing output were 90% and 84%, respectively. Precision was always better with NICOM than with thermodilution. During hemodynamic challenges, changes were 3.1 ± 3.8 min faster with NICOM (p < 0.01) and amplitude of changes did not differ significantly. Finally, sensitivity of the NICOM for detecting significant directional changes was 93% and specificity was 93%. Conclusion: Cardiac output measured by NICOM had most often acceptable accuracy, precision, and responsiveness in a wide range of circulatory situations.

Introduction
Until now, continuous monitoring of cardiac output (CO) in the intensive care unit has been achieved only by invasive methods such as continuous thermodilution with a pulmonary artery catheter (PAC-CCO) [1], an arterial catheter for pulse contour analysis [2, 3], an intra-tracheal tube for partial CO2 re-breathing [4], or an intra-esophageal probe for continuous Doppler velocity

flow assessment [5, 6]. A non-invasive method would be useful, especially for low-risk patients in whom CO monitoring is rarely used at present, given the potential side effects of invasive procedures. Thoracic bioimpedance was the first non-invasive method for CO monitoring [7–9], but inconsistent accuracy was found in intensive care [10, 11]. A new signal processing method has been developed (NICOM, Cheetah Medical, Inc. Wilmington, DE). In addition to

4% and 98. 1 Regression PAC-CCO vs. The regression coefficients between thermodilution and Nine patients were excluded because there was clear NICOM values including 9.0) not significantly different from the identity line (red dotted line) . using PAC-CCO as reference. slope = 0. We prospectively defined clinically acceptable tolerances for the performance parameters: (1) 20% for bias. the NICOM signal is based on the frequency-modulation and phase-modulation of the output voltage. we developed an original method (detailed in the Electronic Supplementary Material). two severe tricuspid regurgitation leading to er. (2) the amplitude-modulation recorded by old systems. NICOM (each point represents the mean CO value during a period of stable CO). and (4) reliable detection of directional changes in CO [12].64–1. Results Fig. left ventricular ejection fraction 47 ± 12%. Connecting the NICOM to the patient requires four double electrode stickers placed on the thorax.6% of the patients were inside the limits > 2+ and a systolic wave > 5 mmHg on the right atrial pressure curve).82 (95%CI = 0.71 (95%CI interferences between an implanted pace-maker and the 0. The purpose of this study was to test the clinical acceptability of NICOM in critically ill patients.71 l/min (+3.The proportion of points with acceptable bias (< 20%) roneous thermodilution (defined as a Doppler regurgitation was 80. age 68 ± 11 years.70–0. CA). The bias was calculated and illustrated by the Bland–Altman approach. Data analysis CO values were compared using linear regressions analysis. To address these issues.05 was considered significant.06 ± 0. this traditional approach did not allow dealing with our predetermined criteria of clinical acceptability. Irvine. A PAC–CCO catheter was used (Edwards Life Sciences.79 to 9. Bias PAC-CCO and NICOM were automatically recorded using a computer data logger on a minute-by-minute basis. This advanced bioreactance technology yields a signal to noise ratio improved 100-fold. In particular. Time-averaged thermodilution CO ranged from 2.72).0 ± 16. precision is affected by natural CO changes and by the large variability and the low time responsiveness of CO monitoring using thermodilution [13]. Basically.888 pairs of CO values (599 ± 341 min per patient). (3) good responsiveness (time and amplitude). The database segmentation and We studied 119 consecutive patients requiring PAC in the complete results are given in the ESM.64.9%). we evaluated (4) reliability for CO directional changes. Bias was +0. (2) small random error of measurements around the true value (precision).08) The protocol was approved by our institutional review and 65% of the data was obtained when patients were board. Informed consent was obtained from each patient. Inotropic agents were used in 12 patients.1192 Data were available from 110 patients with 65. and vasopressors in 9 patients. increasing and decreasing CO using thermodilution trend slopes. it was necessary to distinguish periods of stable. and four early NICOM disconnections due to agitation. All values were reported as mean ± SD. Slope = 0. R = 0. However. p < 0.004 points during 40 perievidence of a situation leading to unrealistic results: three ods of stable CO were R = 0. Periods of rapid CO increase or decrease following acute hemodynamic challenges were also analyzed independently.27 l/min (mean 4. Six patients Methods had chronic obstructive pulmonary diseases. immediate postoperative period following cardiac surgery. mechanically ventilated. Finally. Unacceptable discordances in directional changes were defined as a difference > 20% between the two slopes or as a negative intra-class correlation. Postoperative pulmonary hypertension (systolic pressure > 40 mmHg) Patients occurred in 23 patients. 20% for precision and (3) same responsiveness.82. Clinical acceptability was prospectively defined as: (1) small bias of measurement (accuracy). NICOM. vasodilators in 24 patients.74 ± 1.

3 stops in dobutamine infusion).0 –28 ± 14 4.1 –1. Overall. Corresponding values during periods of decreasing output were 90% and 84%. the number of false positives was 6. Reliability for detecting directional changes We identified 236 periods of time with unchanged (n = 82). as decreases were noted in both SvO2 and blood pressure.9%.9 40 ± 26 PAC-CCO 7. and the number of false negatives was 11. NICOM precision was always better than thermodilution. The proportion of blanks (no values) given by the PAC-CCO was 3. 13–15].52 l/min (+4. In the 2 other patients. Therefore. the relationship between NICOM and thermodilution improved (Fig. and 95% were inside the limits of agreement.25 0.3 –1. Bias was +0. The averaged-time responsiveness of the NICOM was 3 min faster than thermodilution and the amplitude responsiveness was not significantly different. When CO changed. a fall in PAC-CCO was observed.3%). it would have been impossible to compare precision and responsiveness because they require too much time due to manual data acquisition and averaging of several measurements.4 ± 1.07 of agreement of the Bland–Altman plot. For the 14 patients whose CO values fell with both methods. but we were interested in comparing the NICOM with another automatic and continuous monitoring tool. The precision of PAC-CCO measurements around the slope (2SD/mean) was 14% ± 4%. Moreover. PAC-CCO was taken as reference because we have no better reference for continuous CO monitoring [1. 6 dobutamine challenge. the number of true-positive detections of directional changes in CO was 143. the thermodilution and NICOM slopes were comparable: 0% ± 6% vs.0 ± 2. 1). sensitivity and specificity for detecting clinically relevant PAC-CCO changes were both 93%. 6 high PEEP stops.1 ± 11.16 ± 0. respectively.08.07 0. There are no hard rules for tolerance. both NICOM and PAC-CCO increased (Table 1). 20]. in 16 patients.7 ± 1. During periods of increasing output.01 0. Also.8 ± 3. Bias was independently and inversely related to PAC-CCO values (p < 0. slopes were similar in 96% of patients and intra-class correlation was acceptable in 96%.1193 Table 1 CO changes after hemodynamic challenges Negative CO challenge (n = 14) Lag time (min) Amplitude (l/min) Amplitude (%) Positive CO challenge (n = 23) Lag time (min) Amplitude (l/min) Amplitude (%) NICOM 3.2 1. A ± 30% limit of acceptability has been empirically proposed for cardiac output [18]. –1% ± 9% (NS). p = 0. In all of the 23 challenges. and 4 adrenaline infusions). Finally. Using either of these two methods.1 ± 3. although PAC-CCO was significantly decreased. When CO was averaged for each of the 40 periods of stable CO. 12% ± 7% for the NICOM respectively. The bias was negligible when averaged and was acceptable in 85% of cases. 19. Precision During periods of stable CO. We consider here the reference method variability as limit of acceptability. the averaged response is shown in Table 1. vs.0001) and body surface area (p < 0.02). A rapid decrease in CO was expected in 18 patients (14 PEEP challenges. In the other two patients. precision was better with NICOM than PAC-CCO: 16% ± 10% vs. Since thermodi- . sensitivity for significant directional changes was 93% and specificity was 93%. it would have been impossible to collect enough data to identify statistically eventual factors associated with bias.2 –34 ± 20 6.2 1. NICOM was unchanged. NICOM decreased was expected. 17. The proportion of patients with acceptable bias (< 20%) was 85%. a fall in PAC-CCO was not documented but probably occurred. Responsiveness A rapid increase in CO was expected in 23 patients (7 rapid fluid challenge. 20% ± 7% (p = 0.002) for decreasing CO.7 ± 1.5 ± 0. increasing (n = 74) and decreasing (n = 80) CO. Fick [16] or bolus thermodilution methods [17] are considered more robust references for CO snapshot measurements.7 ± 1. 23% ± 9% (p < 0.3 50 ± 33 p 0.003 0.25 0. Reported PAC bias values (either CCO or bolus CO) range from 5% to 15% [13. the number of true negatives was 76. Discussion This validation of NICOM demonstrated that a totally non-invasive method of CO monitoring is possible in intensive care medicine. In 16 of these 18 patients.0001) for increasing CO and 16% ± 10% vs. but our criteria are restrictive. Bias was not correlated with the duration of the experiment and was not changed by mechanical ventilation or when any drugs were used.

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