Non-Invasive PCO 2 Monitoring in Infants Hospitalized with Viral Bronchiolitis

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1 Non-Invasive PCO 2 Monitoring in Infants Hospitalized with Viral Bronchiolitis Gal S, Riskin A, Chistyakov I, Shifman N, Srugo I, and Kugelman A Pediatric Department and Pediatric Pulmonary Unit Bnai Zion Medical Center The B&R Rappaport Faculty of Medicine, Technion Haifa, Israel

2 Disclosure SenTec Inc. supported the study by supplying a SenTec monitor and supplies for the study.

3 Introduction Continuous noninvasive monitoring for infants with bronchiolitis in the pediatric ward is important because these infants may deteriorate and get into respiratory failure.

4 Introduction Currently, these infants are followed by: Pulse oximetry Repeated blood gases to assess CO 2 retention.

5 Introduction Arterial blood gas (ABG) represents the gold standard for acquiring blood gases. However, repeated ABGs are not feasible in the pediatric wards. Adequate correlation between venous CO 2 (PvCO 2 ) and arterial CO 2 was shown by several studies. (Yıldızdaş D. Arch Disease Child 2004; Gennis PR. Ann Emerg Med 1985; Harrison AM. Crit Care Med 1997)

6 Introduction Venous gas sampling may cause: Discomfort and pain May not be accurate if the infants cry (hyperventilation) or hold their breath (apnea) during the puncture. Venous gas sampling does not allow continuous monitoring.

7 Introduction Transcutaneous PCO2 (PtcCO2) measurement represents a simple and noninvasive technique for continuous monitoring of ventilation. Measuring PtcCO2 with a new device that does not cause thermal injuries to the skin may enable adequate continuous noninvasive monitoring even in small infants.

8 Introduction Holmegren and Sixt evaluated children with asthmatic symptoms and concluded that the PtcCO2 can be used for monitoring acute bronchial obstruction and for evaluating the effects of treatment in children of different ages. (Pediatr Pulmonol 1992) To the best of our knowledge, no study was performed previously on noninvasive monitoring of PtcCO2 in infants with bronchiolitis in the ER or the Pediatric ward.

9 Study Aim To assess within a feasibility study the correlation, agreement and trending of PtcCO2 monitoring with PvCO2 in infants with viral bronchiolitis in the ER and pediatric department.

10 Methods: Study Design This was a prospective, observational study, conducted at Bnai-Zion Medical Center, Haifa, Israel between January 2011 and March Infants aged 0-18 months with viral bronchiolitis were connected to a PtcCO2 monitoring device, and these measurements were compared to PvCO2 sampling drawn for patient care. The study was approved by the IRB in our center, and parents signed an informed consent.

11 Methods: Study Outcomes Primary outcome measure: Correlation and agreement between PtcCO 2 and PvCO 2. Secondary outcomes: To evaluate if our experience in using the device affected its accuracy, To assess the trending ability of PtcCO 2 measurements, To evaluate the correlation of PtcCO 2 with disease severity.

12 Study Population Included in the study were infants admitted to the ER and hospitalized with the clinical diagnosis of viral bronchiolitis in the pediatric ward. Excluded were infants with skin rash or eruption.

13 Study Procedure Monitoring of the infants, using the SenTec Digital Monitoring System (SenTec Inc. Therwil, Switzerland), was performed and recorded. The sensor was warmed to a constant surface temperature of 42 o C to improve local arterialization of the measurement site.

14 Study Procedure Prior to application of the sensor to the patient, the sensor was prepared and calibrated as per the manufacturer recommendations. The sensor was then applied to the patient s chest or upper abdomen for 15 minutes, allowing a correct stabilization of the PtcCO2 values. We evaluated the recordings, and PtcCO2 values obtained under inadequate conditions were excluded from analysis.

15 Study Procedure Clinical decisions were made only according to the VBG. Patients who were hospitalized and needed further blood gases sampling for clinical assessment were either continuously monitored by the PtcCO 2 device or reconnected to the device before obtaining a repeat venous sample.

16 Study Procedure A disease severity clinical score (1-7) was performed: 1. Respiratory rate>60 breaths/minute, 2. Clinical signs of respiratory distress (retractions, nasal flaring), 3. Oxygen saturation <92% on room air, 4. Oxygen requirement (if SpO2<90%), 5. Heart rate >160 beats/minute 6. Findings of fine crackles 7. Findings of wheezing

17 Results During the study period a total of 100 PvCO2 and PtcCO2 simultaneous samplings were obtained from 61 patients. The median number of sampling per patient was 1 (range: 1-4). In 28 patients we performed more than 1 sampling. No problems related to skin warming or sensor placement were observed.

18 TABLE 1: Patient's Characteristics (n=61 patients) Mean SD. Med. Min. Max Age (months) Weight (Kg) LOS (d) No Readings Medical history No primary diagnosis 47 Congenital heart disease 5 Pulmonary hypertension in neonatal period 3 Prematurity 6 Respiratory distress syndrome 1 Gastro-esophageal reflux 2 Hyper-reactive airway disease 2 Down syndrome 1

19 TABLE 2: Clinical Condition at Study Entry (n=61 patients) Mean SD Respiratory rate (breaths/minute) Heart rate (beats/minute) SpO 2 [%] Clinical parameters (number of patients) Crepitations 32 Wheezing 30 Retraction 34 Feeding problems 15 Oxygen requirement 35

20 Figure 1: Bland Altman plot for PvCO 2 and PtcCO 2 (Bias ± precision: 1.9±7.0 mmhg) (Dashed line represents ±1.96 SD).

21 Figure 2: Correlation between PvCO2 and PtcCO2 (r = 0.71, P<0.001)

22 Learning Curve Towards the last year of the study The correlation coefficient improved from 0.67 to The bias increased from 0.6 mmhg to 4.6 mmhg, but the precision decreased from 7.7 mmhg to 4.3 mmhg, just not showing a consistent trend.

23 Trending We evaluated the correlation of changes in PvCO2 and the simultaneous changes in PtcCO 2 for consecutive measurements within each patient and found an adequate correlation (r = 0.41, P<0.01).

24 Disease Severity Positive linear correlation between PtcCO 2 and the disease severity clinical score (p<0.001). By replacing the disease severity clinical score with its components in a multiple regression model: Need for oxygen (p<0.005), Heart rate (p<0.05), Respiratory rate (p<0.05) Were all correlated with PtcCO 2.

25 Discussion Main Findings We found that PtcCO 2 was a feasible noninvasive method for estimating PvCO 2 in patients with viral bronchiolitis in the ER and the pediatric department.

26 Discussion Feasibility The use of PtcCO 2 has already been evaluated in patients hospitalized in NICU and PICU. However, there are only a few studies in the settings of ER or in the pediatric department, and there are no previous reports to our knowledge in infants with bronchiolitis. A study (Wennergren G. Acta Paediatr 1986) in children (<2 years) with asthmatic symptoms in the pediatric ward, PtcCO2 overestimated the arterial CO2 on an average of 3.0±3.4 mmhg, Most probably due to metabolic CO2 production in the epidermis cells. (Marsden D. Arch Dis Child 1985)

27 Discussion Feasibility Our results (correlation and agreement) are consistent with previous results in other clinical conditions and settings. While there is no definition for and adequate agreement for PtcCO 2, a bias of <5 mmhg was considered adequate for ETCO 2. (Hagerty JJ. J Perinatol 2002; Rozycki HJ. Pediatrics 1998, Sivan Y. Ped. Pulmonol 1992) Our results comply with that definition.

28 Discussion Feasibility Thus, as PtcCO2 performed by the medical and nursing teams in the ER and the pediatric department revealed a good agreement and correlation with PvCO2.

29 Discussion PvCO 2 vs. PaCO 2 PvCO2 was reported to be larger than the PaCO2 by a mean of 5.7 mmhg and the measurements had excellent correlation (r=0.97). (Yıldızdaş D. Arch Disease Child 2004) This study supports our clinical decision to use PvCO2 as a practical medical tool. In our study we found that the PtcCO2 was lower than the PvCO2 by a mean difference of 1.9±7.0 mmhg as opposed to other studies that used PaCO2. The use of PvCO2 instead of PaCO2 can explain the different direction of the bias.

30 Discussion PtcCO 2 vs. ETCO 2 PtcCO 2 might be a better method for non-invasive assessment of CO 2 compared with ETCO 2 Nasal discharge Nasal oxygen flow Only one study was published on the use of ETCO 2 in bronchiolitis. (Lashkeri T. Pediatr Emerg Care 2012) No correlation between the ETCO 2 reading and the infants' clinical score. The study did not validate the ETCO 2 results with blood gases. Thus, more studies and "head to head" comparison of the two methods is required.

31 Discussion Continuous Respiratory Monitoring Continuous respiratory monitoring is important in infants hospitalized with bronchiolitis. Oxygen saturation is already a standard of care, But, non-invasive monitoring of CO 2 is not performed routinely. The ability to predict ventilatory deterioration as early as possible is crucial. For this we need trending ability.

32 Discussion Trending Ability of PtcCO2 We found only an adequate correlation within each patient. Small number of infants with more than one reading Small number of readings within each patient. We had only one SenTec Digital Monitoring System. Infants admitted were transferred from the ER to the pediatric department. As trending ability may be more important than obtaining a certain PtcCO2 level, More studies evaluating the trending ability of PtcCO2 in bronchiolitis are needed before relying on that method in clinical care.

33 Discussion Clinical Score Infants with bronchiolitis in the ER and pediatric department need mainly supportive care and monitoring. The level of PtcCO 2 correlated with disease severity clinical score (P<0.001), and its individual component; Oxygen requirement, Heart rate, Respiratory rate. This implies a potential role for PtcCO 2 as an assessment tool for disease severity in infants with bronchiolitis.

34 Discussion Training During the study period the medical team (doctors and nurses) has changed, and every year the staff needed updated guidance on the monitoring system. Improper use can lead to incorrect results. In the third study period the correlation coefficient improved from 0.67 to This result confirms that education and experience in the ER and pediatric department could enhance the usefulness of PtcCO 2 monitoring in bronchiolitis.

35 Discussion Study Limitations Relative small number of participants with more than one measurement. Technical constraints, related to the heavy workload in the ER and the pediatric department during the bronchiolitis season. Use of a single monitor. Hampered our ability to obtain high quality and steady measurements of continuous non-invasive PtcCO 2.

36 Conclusions We conclude that PtcCO 2 is a feasible non-invasive method for estimating PvCO 2 in patients with viral bronchiolitis in the ER and pediatric department. A good correlation and agreement with PvCO 2 and Possible trending ability, May serve as an additional tool for disease severity assessment.

37 Conclusions Further studies are warranted to evaluate the utility of continuous monitoring of PtcCO2 as a predictor of clinical deterioration or improvement in infants with viral bronchiolitis.

38 THANKS

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