Feasibility and impact of a postpartum hemorrhage emergency care package using a bundle approach in Migori County, Kenya.

OBJECTIVE: To investigate the impact of the PPH Emergency Care package (PPH EmC)-a holistic intervention that uses a bundle approach that has been implemented in Kenya, India, Nepal, Bangladesh, and Central America-in a low-resource setting. METHODS: The feasibility and impact of PPH EmC implementation in Migori County, Kenya was studied using a qualitative research design. In March and April 2022 key informants were identified using purposive sampling. Semi-structured interviews were conducted over Zoom from March to May 2022 until thematic saturation was reached. Interviews were transcribed, coded, and analyzed for emerging themes. RESULTS: PPH EmC has positively impacted facility and health system preparedness, referral coordination, teamwork and communication, and overall capacity to provide quality PPH emergency care. Participants reported that PPH EmC is sustainable because of its low cost and support from local partners. CONCLUSION: Implementation of PPH EmC in Migori County, Kenya was feasible and positively impacted PPH emergency care.

Effectiveness of a novel bubble CPAP system for neonatal respiratory support at a referral hospital in the Philippines.

Aim: To examine the impact of introducing and implementing the Vayu bubble continuous positive airway pressure (bCPAP) system on neonatal survival and neonatal respiratory outcomes in a neonatal intensive care unit (NICU) in the Philippines. Methods: We compared clinical outcomes of 1,024 neonates before to 979 neonates after introduction of Vayu bCPAP systems into a NICU. The primary outcome was survival to discharge. Adjusted odds ratios (aORs) with 95% confidence intervals (CIs) were calculated. Analyses were undertaken separately for the entire NICU population and for neonates who received any form of respiratory support. Results: The introduction of the Vayu bCPAP system was associated with (1) significant reductions in intubation (aOR: 0.75; 95% CI: 0.58-0.96) and in the use of nasal intermittent positive-pressure ventilation (NIPPV) (aOR: 0.69; 95% CI: 0.50-0.96) among the entire NICU population and (2) a significant increase in survival to discharge (aOR: 1.53; 95% CI: 1.09-2.17) and significant reductions in intubation (aOR: 0.52; 95% CI: 0.38-0.71), surfactant administration (aOR: 0.60; 95% CI: 0.40-0.89), NIPPV use (aOR: 0.52; 95% CI: 0.36-0.76), and a composite neonatal adverse outcome (aOR: 0.60; 95% CI: 0.42-0.84) among neonates who received any form of respiratory support. Conclusion: The use of the Vayu bCPAP system in a NICU in the Philippines resulted in significant improvement in neonatal respiratory outcomes.

Evaluation of an innovative low flow oxygen blender system for global access.

Background: Safe and effective oxygen delivery methods are not available for the majority of infants and young children globally. A novel oxygen blender system was designed to accurately deliver concentration-controlled, oxygen-enriched air to hypoxemic children up to age five. The system does not require compressed medical air, is compatible with both oxygen tanks and oxygen concentrators, and is low cost. This is the first study that tested the performance of the innovative oxygen blender system. Methods: The performance of the oxygen blender system was assessed in vitro based on delivered oxygen levels and flow rates with an oxygen tank, an oxygen tank using a nasal occlusion model, and an oxygen concentrator. Results: The measured %O2 of the performance test was within ± 5% of full scale (FS) of the target value across all flows and all nasal cannulas. Occlusion testing demonstrated that 50% occlusion did not significantly affect the system outputs. The oxygen blender system was shown to be compatible with both oxygen tanks and oxygen concentrators. Conclusions: The novel oxygen blender system accurately controls oxygen concentrations and blended air flow rates, and is compatible with both oxygen tanks and oxygen concentrators. This innovation may be an opportunity for improved infant and child oxygen treatment worldwide.

Every Second Matters - uterine balloon tamponade implementation across ten medical colleges in Maharashtra and Madhya Pradesh in India: A qualitative study.

OBJECTIVE: To understand facilitators, barriers, and perceptions of the Every Second Matters uterine balloon tamponade (ESM-UBT) package implemented across 10 medical colleges in India, 3 years after the program was introduced. METHODS: Semi-structured interviews were conducted until thematic saturation in March 2020. Multiple provider cadres, including nurses, Obstetrics/Gynecology residents, professors, and program leads, were eligible. Interviews were transcribed and thematically coded using an inductive method. RESULTS: Sixty-two obstetric providers were interviewed. Facilitators of implementation included recurrent training, improved teamwork and communication, strong program leadership, and involvement of lower-level facilities. Barriers to implementation included administrative hurdles, high staff turnover, language barriers, and resources required to reach and train lower-level facilities. Overall, the majority of clinicians viewed the ESM-UBT package as a useful intervention in aiding efforts to reduce maternal deaths from postpartum hemorrhage. CONCLUSIONS: Among 10 medical colleges in India the ESM-UBT package is seen as a beneficial intervention for managing refractory atonic postpartum hemorrhage, and for reducing maternal morbidity and mortality. Identified facilitators of and barriers to implementation of the ESM-UBT package in India should be used to guide future implementation efforts.

Impact of the introduction of a low-cost uterine balloon tamponade (ESM-UBT) device for managing severe postpartum hemorrhage in India: A comparative before-and-after study.

OBJECTIVE: To evaluate the impact of introducing a uterine balloon tamponade (ESM-UBT) device for managing severe postpartum hemorrhage (PPH), mainly due to uterine atony, in health facilities in India on the rates of PPH-related maternal death and invasive procedures for PPH control. METHODS: We used a quasi-experimental, difference-in-difference (DID) design to compare changes in the rates of a composite outcome (PPH-related maternal death and/or artery ligation, uterine compression sutures, or hysterectomy) among women delivering in nine intervention facilities compared with those delivering in two control facilities, before and after the introduction of ESM-UBT. RESULTS: The study sample included 214 123 deliveries (n = 78 509 before ESM-UBT introduction; n = 47 211 during ESM-UBT introduction; and n = 88 403 after ESM-UBT introduction). After introduction of ESM-UBT, there was a significant decline in the rate of the primary composite outcome in intervention facilities (21.0-11.4 per 10 000 deliveries; difference -9.6, 95% confidence interval -14.0 to -5.4). Change in the rate of the primary composite outcome was not significant in control facilities (11.7-17.2 per 10 000 deliveries; difference 5.4, 95% confidence interval -3.9 to 14.9). DID analyses showed there was a significant reduction in the rate of the primary composite outcome in intervention facilities relative to control facilities (adjusted DID estimate -15.0 per 10 000 points, 95% confidence interval -23.3 to -6.8; P = 0.005). CONCLUSION: Introduction of the ESM-UBT in health facilities in India was associated with a significant reduction in PPH-related maternal death and/or invasive procedures for PPH control.

A ketamine package for use in emergency cesarean delivery when no anesthetist is available: An analysis of 401 consecutive operations.

OBJECTIVE: To evaluate the safety and effectiveness of a ketamine-based anesthesia package to support emergency cesarean section when no anesthetist is available. METHODS: A prospective case-series was conducted between December 11, 2013 and September 30, 2021 across nine sub-county hospitals in Kenya. Non-anesthetist healthcare providers undertook an evidence-based five-day training course. A structured instrument was used to collect preoperative, intraoperative, and postoperative data, and patients were contacted 6 months following the surgery to collect outcomes. The primary outcome measures were maternal and newborn survival and the ability of the ketamine package (ESM-Ketamine) to safely support cesarean deliveries. RESULTS: A total of 401 emergency cesarean sections were performed using ketamine, administered by 54 non-anesthetist providers. All mothers survived to discharge. Brief oxygen desaturations were recorded among 33 (8.2%) mothers, and agitation and hallucinations occurred among 13 (3.2%). There were no maternal serious adverse events. At 6-month follow-up, 94.2% of mothers who could be reached reported no complaints. Additionally, 402 (92.4%) of the 435 operative births survived to discharge. CONCLUSION: The ESM-Ketamine package can be used by trained non-anesthetist providers to support emergency cesarean sections when no anesthetist is available. Ketamine has significant potential to increase access to emergency cesarean deliveries in resource-limited settings.

Evaluation of a Bubble CPAP System for Low Resource Settings.

BACKGROUND: Despite its established safety, efficacy, and relative simplicity, CPAP treatment is not widely available for newborns and infants in low- and middle-income settings. A novel bubble CPAP system was designed to address the gaps in quality and accessibility of existing CPAP systems by providing blended, humidified, and pressurized gases without the need for electricity, compressed air, or manual power. This was the first study that tested the performance of the system with a simulated patient model. METHODS: In a spontaneously breathing 3-dimensional printed nasal airway model of a preterm neonate, CPAP performance was assessed based on delivered pressure, oxygen level, and humidity at different settings. RESULTS: Preliminary device performance characteristics were within 5% among 3 separate devices. Performance testing showed accurate control of CPAP and oxygen concentration at all settings with the bubble CPAP system. Lung model pressure and oxygen concentration were shown to stay within ±0.5 cm H2O and ±4% of full scale of the device settings, respectively, with relative humidity > 80%. CONCLUSIONS: Performance testing of the bubble CPAP system demonstrated accurate control of CPAP and oxygen concentration with humidity levels suitable for premature newborns on noninvasive support.

A review of postpartum hemorrhage in low-income countries and implications for strengthening health systems.

Postpartum hemorrhage (PPH) is the leading cause of maternal morbidity and mortality worldwide. Disparities in PPH-associated survival between high and low-/middle-income countries reflect an imperative for low-resource countries to improve strategies for rapid diagnosis and treatment. A review of current PPH diagnosis, prevention, treatment, and access to care in low-income countries has been used to understand, extract, and report the challenges that public health systems face in trying to solve the marked global disparity in PPH outcomes. Improvement in PPH survival begins with holistic strengthening of each step along the continuum of care in health systems and should include performance feedback measures and quality-of-care research.

Re-Examining the Race to Send Ventilators to Low-Resource Settings.

COVID-19 is devastating health systems globally and causing severe ventilator shortages. Since the beginning of the outbreak, the provision and use of ventilators has been a key focus of public discourse. Scientists and engineers from leading universities and companies have rushed to develop low-cost ventilators in hopes of supporting critically ill patients in developing countries. Philanthropists have invested millions in shipping ventilators to low-resource settings, and agencies such as the World Health Organization and the World Bank are prioritizing the purchase of ventilators. While we recognize the humanitarian nature of these efforts, merely shipping ventilators to low-resource environments may not improve outcomes of patients and could potentially cause harm. An ecosystem of considerable technological and human resources is required to support the usage of ventilators within intensive care settings. Medical-grade oxygen supplies, reliable electricity, bioengineering support, and consumables are all needed for ventilators to save lives. However, most ICUs in resource-poor settings do not have access to these resources. Patients on ventilators require continuous monitoring from physicians, nurses, and respiratory therapists skilled in critical care. Health care workers in many low-resource settings are already exceedingly overburdened, and pulling these essential human resources away from other critical patient needs could reduce the overall quality of patient care. When deploying medical devices, it is vital to align the technological intervention with the clinical reality. Low-income settings often will not benefit from resource-intensive equipment, but rather from contextually appropriate devices that meet the unique needs of their health systems.

A condom uterine balloon device among referral facilities in Dar Es Salaam: an assessment of perceptions, barriers and facilitators one year after implementation.

BACKGROUND: Postpartum hemorrhage (PPH) is the leading cause of maternal death in Tanzania. The Every Second Matters for Mothers and Babies- Uterine Balloon Tamponade (ESM-UBT) device was developed to address this problem in women with atonic uterus. The objective of this study was to understand the barriers and facilitators to optimal use of the device, in Dar es Salaam Tanzania 1 year after implementation. METHODS: Semi-structured interviews of skilled-birth attendants were conducted between May and July 2017. Interviews were recorded, coded and analyzed for emergent themes. RESULTS: Among the participants, overall there was a positive perception of the ESM-UBT device. More than half of participants reported the device was readily available and more than 1/3 described ease and success with initial use. Barriers included fear and lack of refresher training. Finally, participants expressed a need for training and device availability at peripheral hospitals. CONCLUSION: The implementation and progression to optimal use of the ESM-UBT device in Tanzania is quite complex. Ease of use and the prospect of saving a life/preserving fertility strongly promoted use while fear and lack of high-level buy-in hindered utilization of the device. A thorough understanding and investigation of these facilitators and barriers are required to increase uptake of the ESM-UBT device.

Uterine balloon tamponade for the treatment of postpartum hemorrhage: a systematic review and meta-analysis.

OBJECTIVE: To assess the efficacy, effectiveness, and safety of uterine balloon tamponade for treating postpartum hemorrhage. STUDY DESIGN: We searched electronic databases (from their inception to August 2019) and bibliographies. We included randomized controlled trials, nonrandomized studies, and case series that reported on the efficacy, effectiveness, and/or safety of uterine balloon tamponade in women with postpartum hemorrhage. The primary outcome was the success rate of uterine balloon tamponade for treating postpartum hemorrhage (number of uterine balloon tamponade success cases/total number of women treated with uterine balloon tamponade). For meta-analyses, we calculated pooled success rate for all studies, and relative risk with 95% confidence intervals for studies that included a comparative arm. RESULTS: Ninety-one studies, including 4729 women, met inclusion criteria (6 randomized trials, 1 cluster randomized trial, 15 nonrandomized studies, and 69 case series). The overall pooled uterine balloon tamponade success rate was 85.9% (95% confidence interval, 83.9-87.9%). The highest success rates corresponded to uterine atony (87.1%) and placenta previa (86.8%), and the lowest to placenta accreta spectrum (66.7%) and retained products of conception (76.8%). The uterine balloon tamponade success rate was lower in cesarean deliveries (81.7%) than in vaginal deliveries (87.0%). A meta-analysis of 2 randomized trials that compared uterine balloon tamponade vs no uterine balloon tamponade in postpartum hemorrhage due to uterine atony after vaginal delivery showed no significant differences between the study groups in the risk of surgical interventions or maternal death (relative risk, 0.59; 95% confidence interval, 0.02-16.69). A meta-analysis of 2 nonrandomized before-and-after studies showed that introduction of uterine balloon tamponade in protocols for managing severe postpartum hemorrhage significantly decreased the use of arterial embolization (relative risk, 0.29; 95% confidence interval, 0.14-0.63). A nonrandomized cluster study reported that use of invasive procedures was significantly lower in the perinatal network that routinely used uterine balloon tamponade than that which did not use uterine balloon tamponade (3.0/1000 vs 5.1/1000; P < .01). A cluster randomized trial reported that the frequency of postpartum hemorrhage-related invasive procedures and/or maternal death was significantly higher after uterine balloon tamponade introduction than before uterine balloon tamponade introduction (11.6/10,000 vs 6.7/10,000; P = .04). Overall, the frequency of complications attributed to uterine balloon tamponade use was low (≤6.5%). CONCLUSION: Uterine balloon tamponade has a high success rate for treating severe postpartum hemorrhage and appears to be safe. The evidence on uterine balloon tamponade efficacy and effectiveness from randomized and nonrandomized studies is conflicting, with experimental studies suggesting no beneficial effect, in contrast with observational studies. Further research is needed to determine the most effective programmatic and healthcare delivery strategies on uterine balloon tamponade introduction and use.

Postpartum hemorrhage care bundles to improve adherence to guidelines: A WHO technical consultation.

OBJECTIVE: To systematically develop evidence-based bundles for care of postpartum hemorrhage (PPH). METHODS: An international technical consultation was conducted in 2017 to develop draft bundles of clinical interventions for PPH taken from the WHO's 2012 and 2017 PPH recommendations and based on the validated "GRADE Evidence-to-Decision" framework. Twenty-three global maternal-health experts participated in the development process, which was informed by a systematic literature search on bundle definitions, designs, and implementation experiences. Over a 6-month period, the expert panel met online and via teleconferences, culminating in a 2-day in-person meeting. RESULTS: The consultation led to the definition of two care bundles for facility implementation. The "first response to PPH bundle" comprises uterotonics, isotonic crystalloids, tranexamic acid, and uterine massage. The "response to refractory PPH bundle" comprises compressive measures (aortic or bimanual uterine compression), the non-pneumatic antishock garment, and intrauterine balloon tamponade (IBT). Advocacy, training, teamwork, communication, and use of best clinical practices were defined as PPH bundle supporting elements. CONCLUSION: For the first response bundle, further research should assess its feasibility, acceptability, and effectiveness; and identify optimal implementation strategies. For the response to refractory bundle, further research should address pending controversies, including the operational definition of refractory PPH and effectiveness of IBT devices.

Mechanical Properties of the Every Second Matters for Mothers-Uterine Balloon Tamponade (ESM-UBT) Device: In Vitro Tests.

Objective Postpartum hemorrhage (PPH) is the most common cause of maternal mortality and morbidity worldwide, most of which occurs in resource-poor settings. Placement of a uterine balloon may be life-saving in uncontrolled PPH. The Every Second Matters for Mothers-Uterine Balloon Tamponade (ESM-UBT) device is an ultra-low-cost uterine balloon designed for global access. The purpose of this study was to evaluate the mechanical properties of the ESM-UBT device. Study design Intraluminal pressures, diameters, and burst volumes of condom uterine balloons and Foley catheter balloons of ESM-UBT devices were measured in open air and inside uterus models. Condom uterine balloons were tested with uterus model sizes of 100, 250, and 500mL. The condom-catheter O-ring attachment tensile strength was also evaluated. Results All 28 samples of ESM-UBT condom uterine balloons maintained their integrity for at least 3 hours when subjected to pressures of 200 mm Hg or greater across each of the tested uterine volumes. No Foley catheter balloons burst after instillation of 30mL, O-rings withstood forces of 15.4 ± 2.1 N, and condom uterine balloons stretched to 35.8 ± 2.1 cm without loss of integrity. Conclusion The mechanical properties of the ESM-UBT device make it attractive for scale across resource-poor settings.

Intraoperative awareness and experience with a ketamine-based anaesthesia package to support emergency and essential surgery when no anaesthetist is available.

INTRODUCTION: Five of the 7.2 billion people on earth have limited access to emergency and essential surgical procedures. The lack of safe, affordable and timely anaesthesia services are primary barriers to universal surgical coverage. The objective of this study was to assess intraoperative awareness when the 'Every Second Matters for Emergency and Essential Surgery - Ketamine' (ESM-Ketamine) package was used to support emergency and essential surgeries and painful procedures in rural Kenya when no anaesthetist was available. METHODS: Forty-seven consecutive adult patients that underwent an operative procedure under ESM-Ketamine at Sagam Community Hospital in Luanda, Kenya were enrolled. Participants underwent two semi-structured interviews that explored the patient's experience with ESM-Ketamine both after the operative procedure and four to six weeks after surgery. RESULTS: Forty-seven participants completed the first interview and 37 (78.7%) the second interview. Thirty-seven (78.7%) cases were procedural sedations and ten were (21.3%) emergency surgeries. Intraoperative awareness occurred in nine (24.3%) participants who underwent procedural sedation and two (20%) who underwent emergency surgery. Twenty-six (55.3%) participants reported dreams during the procedure. Thirty-two (86.5%) participants considered their experience positive, and 35 (95%) would recommend a procedure supported by ketamine to a friend. DISCUSSION: Most patients whose painful procedures and emergency operations were supported by the ESM-Ketamine package when no anaesthetist was available reported favourable experiences.

Feasibility of a Ketamine Anesthesia Package in Support of Obstetric and Gynecologic Procedures in Kenya When No Anesthetist is Available.

The objective was to assess the feasibility and safety of the ̳Every Second Matters for Emergency and Essential Surgery - Ketamine' (ESM-Ketamine) package in support of obstetric and gynecologic emergency and essential surgery when no anesthetist is available. A consecutive case series was conducted in twelve hospitals across five severely resource-limited counties in Kenya. 530 women underwent obstetric or gynecological operative procedures supported by non-anesthetist clinicians using the ESM-Ketamine package between November 1, 2013 and September 30, 2017. Main outcomes included reasons for ESM-Ketamine activations and ketamine-related adverse events. There were two (0.4%) prolonged (>30 seconds) oxygen desaturations below 92%. Brief oxygen desaturations (<30 seconds) below 92% occurred in 15 (2.8%) cases and 113 (21.3%) were administered diazepam to treat hallucinations or agitation. There were no ketamine-related deaths or injuries. The ESM- Ketamine package appears feasible and safe for use in support of obstetric and gynecologic surgeries when no anesthetist is available.

Hyaluronidase-Assisted Resuscitation in Kenya for Severely Dehydrated Children.

BACKGROUND: Dehydration, mainly due to diarrheal illnesses, is a leading cause of childhood mortality worldwide. Intravenous (IV) therapy is the standard of care for patients who were unable to tolerate oral rehydration; however, placing IVs in fragile, dehydrated veins can be challenging. Studies in resource-rich settings comparing hyaluronidase-assisted subcutaneous rehydration with standard IV rehydration in children have demonstrated several benefits of subcutaneous rehydration, including time and success of line placement, ease of use, satisfaction, and cost-effectiveness. METHODS: A single-arm trial assessing the feasibility of hyaluronidase-assisted subcutaneous resuscitation for the treatment of moderately to severely dehydrated individuals in western Kenya was conducted. Children aged 2 months or older who presented with moderately to severely dehydration clinically warranting parenteral rehydration and had at least 2 failed IV attempts were eligible. Study staff received training on standard dehydration management and hyaluronidase infusion processes. Children received all other standards of care. They were monitored from presentation and through discharge, with a 1-week phone follow-up. Predischarge surveys were completed by caregivers, and semistructured interviews with providers were performed. RESULTS: A total of 51 children were enrolled (median age, 13.0 months; interquartile range of 18 months). Fifty-one patients (100%) had severe dehydration. The median length of subcutaneous infusion was 3.0 hours (interquartile range [IQR], 2.95). The median total subcutaneous infusion was 700.0 mL (IQR, 420 mL). Median time to resolution of moderate to severe dehydration symptoms was 3.0 hours (IQR, 2.95 hours). There were no significant complications. CONCLUSIONS: Hyaluronidase-assisted subcutaneous resuscitation is a feasible alternative to IV hydration in moderately to severely dehydrated children with difficult to obtain IV access in resource-limited areas.