Dataset Information

Pilot test of an online training module on near-infrared spectroscopy monitoring for the randomised clinical trial SafeBoosC-III.

ABSTRACT: BACKGROUND:SafeBoosC-III is an international randomised clinical trial to evaluate the effect of treatment of extremely preterm infants during the first 3 days of life based on cerebral near-infrared spectroscopy (NIRS) monitoring versus treatment and monitoring as usual. To ensure high quality of the trial intervention as well as of patient care, we have developed a multilingual web-based training program to train relevant staff and test their competence. As we enter an under-explored area of e-learning, we have conducted a pilot study on the first of the five modules comprising the web-based training program to test the feasibility of developing such a program for an international trial with limited resources. METHODS:The module in this study focuses on the principles and practice of NIRS monitoring. The pedagogical idea was to integrate training and certification. One-hundred doctors and nurses from five Neonatal Intensive Care Units across China, Spain and Denmark were invited to participate in the pilot study. Upon completion of the NIRS module, participants were invited to evaluate their experience by completing an online survey. Data from closed-ended questions were analysed using descriptive statistics while data from open-ended questions underwent thematic analysis. RESULTS:In total, 81 of 100 invited staff members entered the training module and completed the online survey. The median time and the number of questions to pass the module was 15 minutes and seven questions, respectively. Most staff found the academic level of the learning material and quiz appropriate (85% and 93% of all staff members, respectively), as well as agreeing that the module was relevant to prepare them to 'use the NIRS device' (90%). Thematic analysis revealed issues such as a discrepancy between learning material and quiz questions, lack of clarity, and technical issues. CONCLUSION:We provide evidence of the feasibility of developing a multilingual web-based training program for an international trial, despite challenges such as low budget, language barriers and possibly differences in the clinical training of staff. Exploring the integration of training and certification for international trials, the positive results of this study motivate further developments. TRIAL REGISTRATION:ClinicalTrial.gov, NCT03770741. Registered 10 December 2018.

SUBMITTER: Hansen ML

PROVIDER: S-EPMC7181533 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Pilot test of an online training module on near-infrared spectroscopy monitoring for the randomised clinical trial SafeBoosC-III.

Hansen Mathias Lühr ML Rasmussen Marie Isabel MI Rubin Snorre S Pellicer Adelina A Cheng Guoqiang G Xu Xin X Zhaoqing Yin Y Zoffmann Vibeke V Greisen Gorm G

Trials 20200423 1

<h4>Background</h4>SafeBoosC-III is an international randomised clinical trial to evaluate the effect of treatment of extremely preterm infants during the first 3 days of life based on cerebral near-infrared spectroscopy (NIRS) monitoring versus treatment and monitoring as usual. To ensure high quality of the trial intervention as well as of patient care, we have developed a multilingual web-based training program to train relevant staff and test their competence. As we enter an under-explored a ...[more]

PMID: 32326953

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Project description:BACKGROUND:Cerebral oxygenation monitoring may reduce the risk of death and neurologic complications in extremely preterm infants, but no such effects have yet been demonstrated in preterm infants in sufficiently powered randomised clinical trials. The objective of the SafeBoosC III trial is to investigate the benefits and harms of treatment based on near-infrared spectroscopy (NIRS) monitoring compared with treatment as usual for extremely preterm infants. METHODS/DESIGN:SafeBoosC III is an investigator-initiated, multinational, randomised, pragmatic phase III clinical trial. Inclusion criteria will be infants born below 28?weeks postmenstrual age and parental informed consent (unless the site is using 'opt-out' or deferred consent). Exclusion criteria will be no parental informed consent (or if 'opt-out' is used, lack of a record that clinical staff have explained the trial and the 'opt-out' consent process to parents and/or a record of the parents' decision to opt-out in the infant's clinical file); decision not to provide full life support; and no possibility to initiate cerebral NIRS oximetry within 6?h after birth. Participants will be randomised 1:1 into either the experimental or control group. Participants in the experimental group will be monitored during the first 72?h of life with a cerebral NIRS oximeter. Cerebral hypoxia will be treated according to an evidence-based treatment guideline. Participants in the control group will not undergo cerebral oxygenation monitoring and will receive treatment as usual. Each participant will be followed up at 36?weeks postmenstrual age. The primary outcome will be a composite of either death or severe brain injury detected on any of the serial cranial ultrasound scans that are routinely performed in these infants up to 36?weeks postmenstrual age. Severe brain injury will be assessed by a person blinded to group allocation. To detect a 22% relative risk difference between the experimental and control group, we intend to randomise a cohort of 1600 infants. DISCUSSION:Treatment guided by cerebral NIRS oximetry has the potential to decrease the risk of death or survival with severe brain injury in preterm infants. There is an urgent need to assess the clinical effects of NIRS monitoring among preterm neonates. TRIAL REGISTRATION:ClinicalTrial.gov, NCT03770741. Registered 10 December 2018.

Project description:Although being the golden standard for intrapartum fetal surveillance, cardiotocography (CTG) has been shown to have poor specificity for detecting fetal acidosis. Non-invasive near-infrared-spectroscopy (NIRS) monitoring of placental oxygenation during labour has not been studied yet. The objective of the study was to determine whether changes in placental NIRS values during labour could identify intrapartum fetal hypoxia and resulting acidosis. We included 43 healthy women in active stage of labour at term. CTG and NIRS parameters in groups with vs. without neonatal umbilical artery pH ? 7.20 were compared using Mann-Whitney-U. Receiver-operating-characteristics (ROC) curves were used to estimate predictive value of CTG and NIRS parameters for neonatal pH ? 7.20. A computer-based statistical classification was also performed to further evaluate predictive values of CTG and NIRS for neonatal acidosis. Ten (23%) neonates were born with umbilical artery pH ? 7.20. Compared to group with pH > 7.20, fetal acidosis was associated with more episodes of placental NIRS deoxygenation (9 (range 2-37) vs. 2 (range 0-65); p<0.001), higher velocity of placental NIRS deoxygenation (2.31 (range 0-22) vs. 1 (range 0-49) %/s; p = 0.03), more decelerations on CTG (25 (range 3-91) vs. 10 (range 10-60); p = 0.02), and more prolonged decelerations on CTG (2 (range 0-4) vs. 1 (range 0-3); p = 0.04). Number of placental deoxygenations had the highest prognostic value for fetal/neonatal acidosis (area under the ROC curve 0.85 (95% confidence interval 0.70-0.99). Computer-based classification also identified number of placental deoxygenations as the most accurate classifier, with 25% false positive and 93% true positive rate in the training dataset, with 100% accuracy when applied to the testing dataset. Placental deoxygenations during labour measured by NIRS are associated with fetal/neonatal acidosis. Predictive value of placental NIRS for neonatal acidosis was superior to that of CTG.

Project description:Individualizing mean arterial blood pressure (MAP) based on cerebral blood flow (CBF) autoregulation monitoring during cardiopulmonary bypass (CPB) holds promise as a strategy to optimize organ perfusion. The purpose of this study was to evaluate the accuracy of cerebral autoregulation monitoring using microcirculatory flow measured with innovative ultrasound-tagged near-infrared spectroscopy (UT-NIRS) noninvasive technology compared with transcranial Doppler (TCD).Sixty-four patients undergoing CPB were monitored with TCD and UT-NIRS (CerOx™). The mean velocity index (Mx) was calculated as a moving, linear correlation coefficient between slow waves of TCD-measured CBF velocity and MAP. The cerebral flow velocity index (CFVx) was calculated as a similar coefficient between slow waves of cerebral flow index measured using UT-NIRS and MAP. When MAP is outside the autoregulation range, Mx is progressively more positive. Optimal blood pressure was defined as the MAP with the lowest Mx and CFVx. The right- and left-sided optimal MAP values were averaged to define the individual optimal MAP and were the variables used for analysis.The Mx for the left side was 0.31 ± 0.17 and for the right side was 0.32 ± 0.17. The mean CFVx for the left side was 0.33 ± 0.19 and for the right side was 0.35 ± 0.19. Time-averaged Mx and CFVx during CPB had a statistically significant "among-subject" correlation (r = 0.39; 95% confidence interval [CI], 0.22-0.53; P < 0.001) but had only a modest agreement within subjects (bias 0.03 ± 0.20; 95% prediction interval for the difference between Mx and CFVx, -0.37 to 0.42). The MAP with the lowest Mx and CFVx ("optimal blood pressure") was correlated (r = 0.71; 95% CI, 0.56-0.81; P < 0.0001) and was in modest within-subject agreement (bias -2.85 ± 8.54; 95% limits of agreement for MAP predicted by Mx and CFVx, -19.60 to 13.89). Coherence between ipsilateral middle CBF velocity and cerebral flow index values averaged 0.61 ± 0.07 (95% CI, 0.59-0.63).There was a statistically significant correlation and agreement between CBF autoregulation monitored by CerOx compared with TCD-based Mx.

Dataset Information

Pilot test of an online training module on near-infrared spectroscopy monitoring for the randomised clinical trial SafeBoosC-III.

Publications

Pilot test of an online training module on near-infrared spectroscopy monitoring for the randomised clinical trial SafeBoosC-III.

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