Fetal head position and perineal distension associated with the use of the BD Odon Device™ in operative vaginal birth: a simulation study.

OBJECTIVE: To investigate (1) the placement of the BD Odon Device on the model fetal head and (2) perineal distention during simulated operative vaginal births conducted with the BD Odon Device. DESIGN: Observational simulation study. SETTING: North Bristol NHS Trust, UK. POPULATION OR SAMPLE: Four hundred and forty simulated operative vaginal births. METHODS: Three bespoke fetal mannequins were developed to represent (1) bi-parietal diameter of the 50th centile at term, (2) bi-parietal diameter at the 5th centile at term, and (3) 50th centile head with 2 cm of caput. Siting of the BD Odon Device on model heads was determined before and after 400 simulated operative vaginal births. Variables were analysed to determine their effect on device siting and movement during birth. The fetal mannequins were placed inside a maternal mannequin and the BD Odon Device was placed around the fetal head as per the instructions for use. The location of the air cuff was determined before and after the head was delivered. Perineal distension was determined by recording maximum perineal distention during a simulated operative vaginal birth using the same procedure, as well as scenarios employing an inappropriately non-deflated air cuff (for the BD Odon Device), the Kiwi ventouse and non-rotational forceps. MAIN OUTCOME MEASURES: Site and displacement during birth of the BD Odon Device on a model head. Maximal perineal distension during birth. RESULTS: The BD Odon Device was reliably sited in a standard over the fetal head position (approximately 40 mm above the fetal chin) for all stations, head sizes and positions with no significant displacement. In occipito-posterior births, compared with occipito-anterior or transverse, the BD Odon Device routinely sited further down the fetal head (toward the chin). The BD Odon Device was not associated with more perineal distension compared with forceps or Kiwi ventouse (respectively 21, 26 and 21 mm at posterior fourchette). CONCLUSIONS: The BD Odon Device reliably sited over a safe area of the fetal head in 400 simulated births representative of clinical practice. The BD Odon Device generates similar levels of perineal distension compared with Kiwi ventouse when used correctly. TWEETABLE ABSTRACT: Location of the BD Odon Device on a fetal head in simulation.

Pressure and traction on a model fetal head and neck associated with the use of forceps, Kiwi™ ventouse and the BD Odon Device™ in operative vaginal birth: a simulation study.

OBJECTIVE: To determine the pressure and traction forces exerted on a model fetal head by the BD Odon Device, forceps and Kiwi ventouse during simulated births. DESIGN: Simulation study. SETTING: Simulated operative vaginal birth. POPULATION OR SAMPLE: Eighty-four simulated operative vaginal births. METHODS: A bespoke fetal mannequin with pressure sensors around the head and strain gauge across the neck was used to investigate pressure applied over the head, and traction across the neck during 84 simulated births using the BD Odon Device, non-rotational forceps and Kiwi ventouse. MAIN OUTCOME MEASURES: Peak pressure on the fetal face and lateral aspects of the head during correct use of the BD Odon Device and forceps. Peak pressure on orbits and neck during misplacement of the BD Odon Device and forceps. Peak traction force generated until instrument failure using the BD Odon Device, forceps and Kiwi ventouse. RESULTS: When correctly sited and using 80 kPa inflation pressure on the cuff, the BD Odon Device generated a lower peak pressure on the fetal head than forceps (83 versus 146 kPa). When instruments were purposefully misplaced over the orbits, the BD Odon Device generated a lower peak pressure on the orbits compared with forceps (70 versus 123 kPa). When purposefully misplaced over the neck, the BD Odon Device, compared with forceps, generated a greater peak pressure on the anterio-lateral aspect of the neck (56 versus 17 kPa) and a lower peak pressure on the posterior aspect of the neck (76 versus 93 kPa) than forceps. In cases of true cephalic disproportion, the BD Odon Device 'popped-off' at a lower traction force than did forceps (208 versus 270 N). CONCLUSIONS: In simulated assisted vaginal birth with correctly placed instruments, the peak pressure exerted on the fetal head by a BD Odon Device is lower than the pressure exerted by non-rotational forceps. In cases in which delivery of the fetal head is not possible due to cephalo-pelvic disproportion, lower traction forces could be applied using the BD Odon Device than with forceps before the procedure was abandoned due to device failure. TWEETABLE ABSTRACT: BD Odon Device exerts less pressure on a model fetal head than forceps, but more than Kiwi ventouse.

Design and development of the BD Odon DeviceTM : a human factors evaluation process.

OBJECTIVE: To (1) determine how intended users interact with and use the BD Odon Device in simulation, (2) use these findings to alter progressively the design of the BD Odon Device and (3) validate that these changes have improved the ability of practitioners to use the BD Odon Device. DESIGN: Human factors evaluation study. SETTING: Simulation suite designed to mimic delivery room. POPULATION OR SAMPLE: Three hundred and ninety simulated operative births, performed by 100 practising clinicians. METHODS: Simulated operative vaginal births performed using the BD Odon Device and the device Instructions for use were subjected to three formative human factors evaluations and one human factors validation test. Following each evaluation, findings were reviewed and the design of the BD Odon Device and Instructions for use were modified. MAIN OUTCOME MEASURES: Successful performance of an operative vaginal birth using the BD Odon Device in accordance with provided training and Instructions for use. RESULTS: Using version two of the BD Odon Device, and following exposure to face-to-face training and written instructions, 25% of accouchers were able successfully to perform a simulated operative vaginal birth. In the final evaluation, following device design and training material alterations, all accouchers were able successfully to perform a simulated operative vaginal birth using version four of the BD Odon Device. CONCLUSIONS: Human factors evaluations have enabled a multi-professional device and training materials design team to alter the design of the BD Odon Device and the Instructions for use in an evidence-based fashion. This process has resulted in a device which has a predictable and likely safe pattern of use. TWEETABLE ABSTRACT: Human Factors evaluations help make the BD Odon Device safe and usable for clinical practice.

Prevention of brachial plexus injury-12 years of shoulder dystocia training: an interrupted time-series study.

OBJECTIVE: To investigate management and outcomes of incidences of shoulder dystocia in the 12 years following the introduction of an obstetric emergencies training programme. DESIGN: Interrupted time-series study comparing management and neonatal outcome of births complicated by shoulder dystocia over three 4-year periods: (i) Pre-training (1996-99), (ii) Early training (2001-04), and (iii) Late training (2009-12). SETTING: Southmead Hospital, Bristol, UK, with approximately 6000 births per annum. POPULATION: Infants and their mothers who experienced shoulder dystocia. METHOD: A bi-monthly multi-professional 1-day intrapartum emergencies training course, that included a 30-minute practical session on shoulder dystocia management, commenced in 2000. MAIN OUTCOMES: Neonatal morbidity (brachial plexus injury, humeral fracture, clavicular fracture, 5-minute Apgar score <7) and documented management of shoulder dystocia (resolution manoeuvres performed, traction applied, head-to-body delivery interval). RESULTS: Compliance with national guidance improved with continued training. At least one recognised resolution manoeuvre was used in 99.8% (561/562) of cases of shoulder dystocia in the late training period, demonstrating a continued improvement from 46.3% (150/324, P < 0.001) pre-training, and 92% (241/262, P < 0.001) in the early training period. In parallel there was reduction in the brachial plexus injury at birth (24/324 [7.4%, P < 0.01], pre-training, 6/262 [2.3%] early training, and 7/562 [1.3%] late training. CONCLUSIONS: There are significant benefits to long-term, embedded training programmes with improvements in both management and outcomes. A decade after the introduction of training there were no cases of brachial plexus injury lasting over 12 months in 562 cases of shoulder dystocia.

Practical simulation training for maternity care--where we are and where next.

Improving maternal and perinatal care is a global priority. Practical simulation training for maternity care might prevent many of these deaths. There have been numerous evaluation studies published on the effectiveness of simulation training for obstetric emergencies, with increasing evidence that it is associated with improvement in clinical outcomes. Evidence has begun to move from subjective assessment of participants' experiences towards objective assessment of clinical outcomes. However, the results are not entirely consistent and, at present, all of the evidence associating training with improvements in clinical outcomes relates to neonatal outcomes. This review summarises recent progress in the evaluation of the effectiveness of simulation training for maternity care in both high- and low-resource settings, and presents a vision for ensuring that practical simulation training for maternity care can become an effective tool to reduce global maternal and perinatal morbidity and mortality.

Clinical efficiency in a simulated emergency and relationship to team behaviours: a multisite cross-sectional study.

OBJECTIVE: To identify specific aspects of teamworking associated with greater clinical efficiency in simulated obstetric emergencies. DESIGN: Cross-sectional secondary analysis of video recordings from the Simulation & Fire-drill Evaluation (SaFE) randomised controlled trial. SETTING: Six secondary and tertiary maternity units. SAMPLE: A total of 114 randomly selected healthcare professionals, in 19 teams of six members. METHODS: Two independent assessors, a clinician and a language communication specialist identified specific teamwork behaviours using a grid derived from the safety literature. MAIN OUTCOME MEASURES: Relationship between teamwork behaviours and the time to administration of magnesium sulfate, a validated measure of clinical efficiency, was calculated. RESULTS: More efficient teams were likely to (1) have stated (recognised and verbally declared) the emergency (eclampsia) earlier (Kendall's rank correlation coefficient τ(b) = -0.53, 95% CI from -0.74 to -0.32, P=0.004); and (2) have managed the critical task using closed-loop communication (task clearly and loudly delegated, accepted, executed and completion acknowledged) (τ(b) = 0.46, 95% CI 0.17-0.74, P=0.022). Teams that administered magnesium sulfate within the allocated time (10 minutes) had significantly fewer exits from the labour room compared with teams who did not: a median of three (IQR 2-5) versus six exits (IQR 5-6) (P=0.03, Mann-Whitney U-test). CONCLUSIONS: Using administration of an essential drug as a valid surrogate of team efficiency and patient outcome after a simulated emergency, we found that more efficient teams were more likely to exhibit certain team behaviours relating to better handover and task allocation.

More to teamwork than knowledge, skill and attitude.

OBJECTIVE: To assess whether team performance in simulated eclampsia is related to the knowledge, skills and attitudes of individual team members. DESIGN: Cross-sectional analysis of data from the Simulation and Fire Drill Evaluation randomised controlled trial. SETTING: Six secondary and tertiary maternity units in south-west England. PARTICIPANTS: One hundred and fourteen maternity professionals in 19 teams of six members; one senior and one junior obstetrician; two senior and two junior midwives. METHODS: We validated a team performance ranking scheme with respect to magnesium administration (Magnesium Administration Rank, MAR) by expert consensus (face validity) and correlation with clinical measures (construct validity). We tested for correlation between MAR and measures of knowledge, skills and attitudes. MAIN OUTCOME MEASURES: Correlation between team performance (MAR) and scores in validated multiple-choice questionnaires (MCQs) (knowledge), a measure of individual manual skill to manage an obstetric emergency (skill) and scores in a widely used teamwork/safety attitude questionnaire (attitude). RESULTS: There was no relationship between team performance and cumulative individual MCQs, skill or teamwork/safety attitude scores. CONCLUSIONS: The knowledge, manual skills and attitudes of the individuals comprising each team, measured by established methods, did not correlate in this study with the team's clinical efficiency in the management of simulated eclampsia. The inference is that unidentified characteristic(s) play a crucial part in the efficiency of teams managing emergencies. Any emphasis of training programmes to promote individual knowledge, skills and attitudes alone may have to be re-examined. This highlights a need to understand what makes a team efficient in dealing with clinical emergencies.

The active components of effective training in obstetric emergencies.

Confidential enquiries into poor perinatal outcomes have identified deficiencies in team working as a common factor and have recommended team training in the management of obstetric emergencies. Isolated aviation-based team training programmes have not been associated with improved perinatal outcomes when applied to labour ward settings, whereas obstetric-specific training interventions with integrated teamwork have been associated with clinical improvements. This commentary reviews obstetric emergency training programmes from hospitals that have demonstrated improved outcomes to determine the active components of effective training. The common features identified were: institution-level incentives to train; multi-professional training of all staff in their units; teamwork training integrated with clinical teaching and use of high fidelity simulation models. Local training also appeared to facilitate self-directed infrastructural change.

Documentation of simulated shoulder dystocia: accurate and complete?

OBJECTIVE: To investigate completeness and accuracy of record keeping by comparison of documentation and actual events, recorded on video and through a force-monitoring device, during simulated shoulder dystocia. DESIGN: An observational study. SETTING: Six maternity units in South West of England. POPULATION: Seventy-one midwives and 39 doctors. METHODS: Doctors and midwives documented their management of a shoulder dystocia simulation on paper used in their hospital (simple notepaper or preformatted form). Documentation was compared with video recording of each simulation and an electronic record of force applied during delivery. MAIN OUTCOME MEASURES: Documentation of head-to-body delivery time (and comparison with actual delivery time). Documentation of force (and comparison with actual applied force). RESULTS: A total of 110 participants documented their actions, 70.9% used a preformatted sheet, 29.1% used hospital notepaper. Fifty-six percent documented head-to-body delivery interval (HBDI) with 56% overestimating the time by more than 1 minute. Force used during the simulation was documented by 70.9%, with no relationship between the subjective description of force applied and the maximum recorded force. The anterior shoulder was documented by 78.2% and correctly identified in 80%. Documentation of force was more likely if a preformatted sheet was used (88 versus 53%, P = 0.016). Documentation of the laterality of the anterior shoulder was tended to be more accurate with plain hospital notepaper (93 versus 78%, P = 0.3526). CONCLUSIONS: Manoeuvres performed were well documented. HBDI and force applied were not documented accurately in the majority of simulated deliveries. Use of a preformatted sheet appeared to improve completeness, but not accuracy, of documentation.

Change in knowledge of midwives and obstetricians following obstetric emergency training: a randomised controlled trial of local hospital, simulation centre and teamwork training.

OBJECTIVES: To explore the effect of obstetric emergency training on knowledge. Furthermore, to assess if acquisition of knowledge is influenced by the training setting or teamwork training. DESIGN: A prospective randomised controlled trial. SETTING: Training was completed in six hospitals in the South West of England, UK and at the Bristol Medical Simulation Centre, UK. POPULATION: Midwives and obstetric doctors working for the participating hospitals were eligible for inclusion in the study. A total of 140 participants (22 junior and 23 senior doctors, 47 junior and 48 senior midwives) were studied. METHODS: Participants were randomised to one of four obstetric emergency training interventions: (1) 1-day course at local hospital, (2) 1-day course at simulation centre, (3) 2-day course with teamwork training at local hospital and (4) 2-day course with teamwork training at simulation centre. MAIN OUTCOME MEASURES: Change in knowledge was assessed by a 185 question Multiple-Choice Questionnaire (MCQ) completed up to 3 weeks before and 3 weeks after the training intervention. RESULTS: There was a significant increase in knowledge following training; mean MCQ score increased by 20.6 points (95% CI 18.1-23.1, P < 0.001). Overall, 123/133 (92.5%) participants increased their MCQ score. There was no significant effect on the MCQ score of either the location of training (two-way analysis of variants P = 0.785) or the inclusion of teamwork training (P = 0.965). CONCLUSIONS: Practical, multiprofessional, obstetric emergency training increased midwives' and doctors' knowledge of obstetric emergency management. Furthermore, neither the location of training, in a simulation centre or in local hospitals, nor the inclusion of teamwork training made any significant difference to the acquisition of knowledge in obstetric emergencies.

Patient-actor perception of care: a comparison of obstetric emergency training using manikins and patient-actors.

OBJECTIVE: To explore the effect of training on patient-actor perception of care during simulated obstetric emergencies. METHOD: A subanalysis from a prospective randomised controlled trial in six UK hospitals and the Bristol Medical Simulation Centre, UK. Midwives and doctors working in participating hospitals were eligible for inclusion. 140 participants (22 junior and 23 senior doctors, 47 junior and 48 senior midwives) were randomised to one of four obstetric emergency training interventions: 1-day course at local hospitals; 1-day course at simulation centre; 2-day course with teamwork training at local hospitals; and 2-day course with teamwork training at simulation centre. Local training used patient-actors and low-fidelity part-task trainers whereas simulation centre training used full-bodied computerised manikins and high-fidelity part-task trainers. Three weeks before and after the training, the participants managed three simulated obstetric emergencies. Patient-actors scored their care after each simulation using a patient-actor perception score (communication, safety, respect). RESULTS: The following numbers of scores were awarded: 139 and 132 participant and 46 and 48 team scenarios, before and after training, respectively. There was a significant improvement in all scores in all scenarios after the training (p = 0.017 to >0.001). Perception of safety and communication during postpartum haemorrhage was significantly improved following training with patient-actors compared with training with manikins (safety p = 0.048, communication p = 0.035). Teamwork training offered no additional benefit to patient-actors' perception of their care. CONCLUSIONS: All multiprofessional training improved patient-actor perception of care. Training using a patient-actor may be better at improving perception of safety and communication than training with a computerised manikin simulator.