Development and evaluation of an algorithm for peripheral venous catheter placement (ALCOV): protocol for a quasi-experimental study.

INTRODUCTION: Multiple punctures during peripheral venous catheter (PVC) placement increase the risk of complications. Scoring for adult difficult intravenous access (A-DIVA Scale) exists but has never been assessed in the framework of a care algorithm (scoring associated with a new decision-making tree for puncture conditions, the A-DIVA Tree). We seek to implement an catheter placement algorithm to decrease the mean number of punctures per patient. The algorithm will be adjusted based on obstacles and levers revealed by the analysis of clinical data. The benefits of the algorithm will be assessed using a step-by-step implementation of the approach. METHODS AND ANALYSIS: 794 PVC placements will be recorded in two inclusion centres (50%/50%). In phase I, 297 PVC placements will be collected, and 16 individual semistructured interviews will be conducted to evaluate the centres' practices. In phase II, 200 PVC placements will be recorded to assess the impact of the A-DIVA Scale alone. The interphase will allow preliminary results based development of the A-DIVA Tree. In phase III, 297 PVC placements will be recorded to assess the impact of the algorithm on the mean number of punctures per patient. ETHICS AND DISSEMINATION: The study and related consent forms were approved by an institutional review board (Comité de Protection des Personnes Sud-Méditerranée I) on 25 April 2023 under reference number 2023-A00223-42. The results will be disseminated in the form of original articles, presentations and guidelines. TRIAL REGISTRATION NUMBER: NCT05935228.

Influential factors on the echogenicity of peripheral venous catheters: Insights from an experimental phantom study.

INTRODUCTION: Ultrasound-guided placement of peripheral venous catheters requires appropriate equipment. Among the devices used, peripheral venous catheters have different structure and properties. This study aimed to define the impact of these different factors on the echogenicity of peripheral venous catheters. METHOD: An open comparative study was conducted from September 2022 to May 2023. Thirteen devices were introduced in a standardized manner along the longitudinal and transverse axes with the help of guides into a phantom at different angles. Two criteria defined the echogenicity of these devices: the surface occupied by the device in the image (composite criterion: length and diameter of the device and angle of insertion) and its brightness (average of the pixel intensity of gray). Sixty-five ultrasound images were recorded and postprocessed twice (blinded to the previous measurement) by an expert operator, for reproducibility purposes. RESULTS: The intra-observer reproducibility of all measurements was excellent, with an intra-class coefficient of >0.90 over the entire dataset. On the longitudinal axis, echogenicity was significantly influenced by insertion angle (p = 0.009), device length (p = 0.006), and the interaction of cannula component and insertion angle (p = 0.007). On the transverse axis, no factors significantly influenced the device's echogenicity. DISCUSSION: The echogenicity of a device is an essential component of successful ultrasound-guided peripheral venous catheter placement. Optimizing catheter intrinsic factors such as components of the cannula and length, and extrinsic factor like the insertion angle should be considered in their design and use to reduce puncture failure rates.

Benefits of simulation for ultrasound-guided midline placement training: MC-in-Sim pilot study.

INTRODUCTION: Ultrasound-guided placement of Midlines catheters (MCs) is a standard procedure with many benefits for patients. Even if there are some guidelines worldwide, this invasive technique is still taught at the patient's bed and relies on mentoring in many care centers. The performance of this care by novice practitioners raises ethical and quality of care issues mainly because of its risk of complications. This study aimed to propose and assess a simulation-based learning method for the placement of MCs in novice practitioners. METHODS: A single-center prospective observational study was conducted with anesthesia residents who had no prior experience of Midline placement. Two workshops were planned. The first one consisted of a theoretical training and a simulated practical phase. The second workshop included an assessment of theoretical memorization, a practical exercise and adherence to the training program. RESULTS: The median score of the theoretical memorization was 14.6 (interquartile range [IQR]: 13.5-15.8). The MCs placement time was significantly higher (Med: 12.23 min; IQR: 12.21-12.80) for novice practitioners who did not successfully complete solo MCs placement in simulation versus novice practitioners who successfully completed solo MCs placement in simulation 6.66 min (IQR: 5.92-8.93) (p = 0.002). The number of attempts was significantly higher (p = 0.034) for the novice practitioners who did not successfully complete solo MCs placement in simulation with 67% having performed three punctures, against 0% for the novice practitioners who successfully completed solo MCs placement in simulation. All novice practitioners found this training model efficient for learning how to place MCs and considered it allows for reproducibility in care situations. CONCLUSION: This ultrasound-guided MCs training on simulation is an agile and fast alternative to traditional bedside training for anesthesia novice practitioners.

Research procedure acceptability through women during pregnancy and postpartum: A pilot study.

OBJECTIVE: To assess the feasibility and relevancy of a systematic data collection process in characterizing factors influencing research acceptability through women during pregnancy and early postpartum. METHODS: A pilot prospective observational crossover unicentric study was conducted in Est France. All the women (except language barrier and intensive care transfer) were called upon to complete a survey (33 questions). The primary endpoints were the participation rate and the completeness of the information. The secondary endpoint was the participants' sociodemographic background and preferences regarding research (bivariate analysis, P value <0.20). RESULTS: Within the research period (February 23-March 8, 114 childbirths), 105 women fitting the criteria were called upon for the survey. The participation rate and completeness were high. The participation rate was 93% with six lost to follow-up, and one refusal. The global filling rate was 95%. We highlighted two plausible variables of interests for research participation: women age older (P value 0.119) and level of education (P value 0.176). A sufficient cooling-off period, the commitment of women's health providers, and the possibility to accede research results might favor women's involvement. Acceptability would appear to be decreasing when the protocol implied fetal or neonatal data collection (compared to maternal data), unless research led to a better therapeutic option. CONCLUSION: The data collection process is highly feasible and provide consistent data. Larger-scale output obtention should enhance the conception and rollout of projects, first by calculating sample size based on potentials for recruitments adjusted to populations, characteristics and second by fitting the experimental design to women's expectations.

Is accuracy of estimated fetal weight improved by better image quality scores?

OBJECTIVE: To assess in a group of ultrasound operators of various levels of experience the predictive value of systematic quality scoring to assess estimated fetal weight (EFW) validity. METHODS: Screenshots, sonographer experience, and neonate birth weight were collected for 131 ultrasound examinations in the 7 days before birth. The difference (EFW error) between projected birth weight (EFW + [30 g × interval in days to birth]) and actual birth weight was then assessed (absolute value). Three senior sonographers rated all the screenshots (International Society of Ultrasound in Obstetrics and Gynecology 16-point score for image quality) and interobserver reproducibility was assessed concomitantly. The impact of the score on EFW accuracy was then assessed (univariate analysis). Receiver operating characteristic curves allowed us to assess the score's positive predictive value (PPV) for accurate EFW. RESULTS: Mean birth weight was 2998 ± 954 g and mean EFW error was 8.6% ± 7.1%. Both the sonographer's experience and score significantly impacted the EFW error (P < 0.05). The PPVs of systematic image scores for identifying an EFW error greater than 10% and greater than 15% were appropriate for clinical use (areas under the curve 0.61 and 0.70, respectively). Score reproducibility was modest. CONCLUSION: Low image scores and limited ultrasound expertise are associated with an increased risk of inaccurate EFW.

Improving prenatal care during lockdown: Comparing telehealth and in-person care for low-risk pregnant women in the PROTECT pilot study.

OBJECTIVE: to compare telehealth and in-person care during the COVID-19 lockdown in a population of low-risk pregnant women for prenatal care received and perinatal outcome. METHODS: This single-center study began during the first French lockdown in 2020. Women with at least one telehealth (remote) prenatal care visit were compared with those who received care only in person. Data include results from self-administered surveys and perinatal outcomes. The main outcome was the prenatal care experience, assessed by the 5-point Quality of Prenatal Care Questionnaire (QPCQ) score. Exploratory analyses sought to identify connections between perinatal outcomes and any of their levels of QPCQ score, health/eHealth literacy, stress, and social deprivation scores . RESULTS: The experimental group included 55 women and the control group 52. Maternal and neonatal outcomes were similar in both groups. The mean QPCQ scores did not support any difference between the mothers' experience of prenatal care in each group: 4.15±0.52 in the telehealth and 4.26±0.63 in the in-person groups. Similarly, levels of social deprivation, stress, and health and eHealth literacy did not differ between the groups. CONCLUSION: Regardless of social deprivation or literacy level, both telehealth and in-person monitoring appeared to provide equivalent and good-quality prenatal care experiences during the pandemic, ClinicalTrial.gov registration NCT04368832 (30th April 2020).

Training in Obstetric Ultrasound Biometry: Results from a Multicenter Reproducibility Study.

OBJECTIVES: To assess the intra- and interobserver reproducibility of fetal biometry measurements obtained by trainee (junior) and experienced sonographers (senior) in the contest of two training programs in obstetric ultrasound. METHODS: This was a prospective study on 192 women recruited ensuring an even distribution throughout gestation (18-41 weeks), at University College London Hospital (UCLH), England (87 cases), and at Maternité Regionale Universitaire de Nancy (MRUN), France (105 cases). The training took place in two training centers with experience in ultrasound training and subspecialist training in fetal medicine. Measurements for head circumference (HC), abdominal circumference (AC), and femur length (FL) were obtained twice by junior and senior sonographers, blind to their own and each other's measurements. Differences between and within sonographers were expressed in millimeters and as a percentage of fetal dimensions. Reproducibility was assessed using Bland-Altman plots. RESULTS: Reproducibility was overall high with 95% confidence intervals (CI) within <6% for intraobserver and <8% for interobserver reproducibility. Intraobserver reproducibility was lower within junior than within senior sonographers' measurements for HC (95% CI: <4% versus <3%) and FL (95% CI: <6% and < 5%). Intraobserver reproducibility was similar between the two centers/training programs (AC 95% CI: <6%). Cumulative interobserver reproducibility in both centers was similar to the reproducibility within a single site (95% CI: <5%, <8%, and <7% for HC, AC, and FL, respectively). CONCLUSIONS: Reproducibility of fetal biometry measurement was high in centers with structured training programs regardless of sonographers' experience. Reproducibility was higher in sonographers who completed the training.

Manual rotation of occiput posterior or transverse positions: a systematic review and meta-analysis of randomized controlled trials.

OBJECTIVE: The primary objective of this systematic review was to assess the association between spontaneous vaginal delivery and manual rotation during labor for occiput posterior or transverse positions. Our secondary objective was to assess maternal and neonatal outcomes. DATA SOURCES: An electronic search of PubMed, EMBASE, ClinicalTrials.gov, and the Cochrane Register of Controlled Trials covered the period from January 2000 to September 2021, without language restrictions. STUDY ELIGIBILITY CRITERIA: The eligibility criteria included all randomized trials with singleton pregnancies at ≥37 weeks of gestation comparing the manual rotation groups with the control groups. The primary outcome was the rate of spontaneous vaginal delivery. Additional secondary outcomes were rate of occiput posterior position at delivery, operative vaginal delivery, cesarean delivery, postpartum hemorrhage, obstetrical anal sphincter injury, prolonged second stage of labor, shoulder dystocia, neonatal acidosis, and phototherapy. Subgroup analyses were performed according to types of position (occiput posterior or occiput transverse), techniques used (whole-hand or digital rotation), and parity (nulliparous or parous). METHODS: The quality of each study was evaluated with the revised Cochrane risk-of-bias tool for randomized trials, known as RoB 2. The meta-analysis used random-effects models depending on their heterogeneity, and risks ratios were calculated for dichotomous outcomes. RESULTS: Here, 7 of 384 studies met the inclusion criteria and were selected. They included 1402 women: 704 in the manual rotation groups and 698 in the control groups. Manual rotation was associated with a higher rate of spontaneous vaginal delivery: 64.9% vs 59.5% (risk ratio, 1.09; 95% confidence interval, 1.03-1.16; P=.005; 95% prediction interval, 0.90-1.32). This association was no longer significant after stratification by parity or technique used. Manual rotation was associated with spontaneous vaginal delivery only for the occiput posterior position (risk ratio, 1.08; 95% confidence interval, 1.01-1.15). Furthermore, it was associated with a reduction in occiput posterior or transverse positions at delivery (risk ratio, 0.64; 95% confidence interval, 0.48-0.87) and episiotomies (risk ratio, 0.84; 95% confidence interval, 0.71-0.98). The groups did not differ significantly for cesarean deliveries, operative vaginal deliveries, or neonatal outcomes. CONCLUSION: Manual rotation increased the rate of spontaneous vaginal delivery.

Comparative evaluation of the impact of the COVID-19 lockdown on perinatal experience: A prospective multicentre study.

OBJECTIVES: To compare in the early postpartum the perinatal experience during a COVID-19 related lockdown ('lockdown' group) and a pandemic control group subject to looser restrictions. DESIGN AND SETTING: This national multicentre prospective cohort study took place in four French maternity units. POPULATION: Women were recruited during the postpartum stay for the lockdown and pandemic control groups, according to their enrolment period. Both faced the same labour and delivery restrictions but only the pandemic control group could have a postpartum visitor. MAIN OUTCOME MEASURES: The primary outcome was the perinatal experience during childbirth, assessed by the Labour Agentry Scale (LAS) self-administered questionnaire, completed before discharge. RESULTS: The study included 596 women and analysed 571 of them: 260 in the lockdown group and 311 in the pandemic control group. The mean LAS score was lower in the lockdown group (161.1 ± 26.8, 95% confidence interval [CI] 157.8-164.3 versus 163.3 ± 24.0, 95% CI 160.6-166.0; P = 0.289). In multivariable analysis, the LAS score was lower in the lockdown group (-6.2 points, P = 0.009), in women with caesarean (-21.6 points, P < 0.001) versus spontaneous deliveries, and among women financially impacted by the lockdown (-6.4 points, P = 0.007) or who experienced restrictions during childbirth (-8.1 points, P < 0.001). The LAS score rose with the prenatal care quality score (P < 0.001). CONCLUSIONS: The perinatal experience was more negatively affected by lockdown restrictions than by the looser pandemic restrictions for controls, but mode of delivery remained the main factor influencing this experience.

Optimization of Fetal Biometry With 3D Ultrasound and Image Recognition (EPICEA): protocol for a prospective cross-sectional study.

CONTEXT: Variability in 2D ultrasound (US) is related to the acquisition of planes of reference and the positioning of callipers and could be reduced in combining US volume acquisitions and anatomical structures recognition. OBJECTIVES: The primary objective is to assess the consistency between 3D measurements (automated and manual) extracted from a fetal US volume with standard 2D US measurements (I). Secondary objectives are to evaluate the feasibility of the use of software to obtain automated measurements of the fetal head, abdomen and femur from US acquisitions (II) and to assess the impact of automation on intraobserver and interobserver reproducibility (III). METHODS AND ANALYSIS: 225 fetuses will be measured at 16-30 weeks of gestation. For each fetus, six volumes (two for head, abdomen and thigh, respectively) will be prospectively acquired after performing standard 2D biometry measurements (head and abdominal circumference, femoral length). Each volume will be processed later by both a software and an operator to extract the reference planes and to perform the corresponding measurements. The different sets of measurements will be compared using Bland-Altman plots to assess the agreement between the different processes (I). The feasibility of using the software in clinical practice will be assessed through the failure rate of processing and the score of quality of measurements (II). Interclass correlation coefficients will be used to evaluate the intraobserver and interobserver reproducibility (III). ETHICS AND DISSEMINATION: The study and related consent forms were approved by an institutional review board (CPP SUD-EST 3) on 2 October 2018, under reference number 2018-033 B. The study has been registered in https://clinicaltrials.gov registry on 23 January 2019, under the number NCT03812471. This study will enable an improved understanding and dissemination of the potential benefits of 3D automated measurements and is a prerequisite for the design of intention to treat randomised studies assessing their impact. TRIAL REGISTRATION NUMBER: NCT03812471; Pre-results.