Dataset Information

A feasibility study evaluating a reservoir storage system for continuous oxygen delivery for children with hypoxemia in Kenya.

ABSTRACT:

Background

Supplemental oxygen is an essential treatment for childhood pneumonia but is often unavailable in low-resource settings or unreliable due to frequent and long-lasting power outages. We present a novel medium pressure reservoir (MPR) which delivers continuous oxygen to pediatric patients through power outages.

Methods

An observational case series pilot study assessing the capacity, efficacy and user appraisal of a novel MPR device for use in low-resource pediatric wards. We designed and tested a MPR in a controlled preclinical setting, established feasibility of the device in two rural Kenyan hospitals, and sought user feedback and satisfaction using a standardized questionnaire.

Results

Preclinical data showed that the MPR was capable of bridging power outages and delivering a continuous flow of oxygen to a simulated patient. The MPR was then deployed for clinical testing in nine pediatric patients at Ahero and Suba Hospitals. Power was unavailable for 2% of the total time observed due to 11 power outages (median 4.6 min, IQR 3.6-13.0 min) that occurred during treatment with the MPR. Oxygen flowrates remained constant across all 11 power outages. Feedback on the MPR was uniformly positive; all respondents indicated that the MPR was easy to use and provided clinically significant help to their patients.

Conclusion

We present a MPR oxygen delivery device that has the potential to mitigate power insecurity and improve the standard of care for hypoxemic pediatric patients in resource-limited settings.

SUBMITTER: Otiangala D

PROVIDER: S-EPMC7934496 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature

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Publications

A feasibility study evaluating a reservoir storage system for continuous oxygen delivery for children with hypoxemia in Kenya.

Otiangala Dickson D Agai Nicholas O NO Olayo Bernard B Adudans Steve S Ng Chin Hei CH Calderon Ryan R Forgie Ella E Bachman Christine C Lieberman Daniel D Bell David D Hawkes Michael M Somoskovi Akos A

BMC pulmonary medicine 20210305 1

<h4>Background</h4>Supplemental oxygen is an essential treatment for childhood pneumonia but is often unavailable in low-resource settings or unreliable due to frequent and long-lasting power outages. We present a novel medium pressure reservoir (MPR) which delivers continuous oxygen to pediatric patients through power outages.<h4>Methods</h4>An observational case series pilot study assessing the capacity, efficacy and user appraisal of a novel MPR device for use in low-resource pediatric wards. ...[more]

PMID: 33663453

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Project description:BACKGROUND:Child mortality due to pneumonia is a major global health problem and is associated with hypoxemia. Access to safe and continuous oxygen therapy can reduce mortality; however, low-income countries may lack the necessary resources for oxygen delivery. We have previously demonstrated proof-of-concept that solar-powered oxygen (SPO2) delivery can reliably provide medical oxygen remote settings with minimal access to electricity. This study aims to demonstrate the efficacy of SPO2 in children hospitalized with acute hypoxemic respiratory illness across Uganda. METHODS:Objectives: Demonstrate efficacy of SPO2 in children hospitalized with acute hypoxemic respiratory illness. STUDY DESIGN:Multi-center, stepped-wedge cluster-randomized trial. SETTING:Twenty health facilities across Uganda, a low-income, high-burden country for pediatric pneumonia. Site selection: Facilities with pediatric inpatient services lacking consistent O2 supply on pediatric wards. PARTICIPANTS:Children aged <?5?years hospitalized with hypoxemia (saturation?<?92%) warranting hospital admission based on clinical judgement. Randomization methods: Random installation order generated a priori with allocation concealment. Study procedure: Patients receive standard of care within pediatric wards with or without SPO2 system installed. OUTCOME MEASURES:Primary: 48-h mortality. Secondary: safety, efficacy, SPO2 system functionality, operating costs, nursing knowledge, skills, and retention for oxygen administration. Statistical analysis of primary outcome: Linear mixed effects logistic regression model with 48-h mortality (dependent variable) as a function of SPO2 treatment (before versus after installation), while adjusting for confounding effects of calendar time (fixed effect) and site (random effect). SAMPLE SIZE:2400 patients across 20 health facilities, predicted to provide 80% power to detect a 35% reduction in mortality after introduction of SPO2, based on a computer simulation of >?5000 trials. DISCUSSION:Overall, our study aims to demonstrate mortality benefit of SPO2 relative to standard (unreliable) oxygen delivery. The innovative trial design (stepped-wedge, cluster-randomized) is supported by a computer simulation. Capacity building for nursing care and oxygen therapy is a non-scientific objective of the study. If successful, SPO2 could be scaled across a variety of resource-constrained remote or rural settings in sub-Saharan Africa and beyond. TRIAL REGISTRATION:Clinicaltrials.gov, NCT03851783. Registered on 22 February 2019.

Project description:Voluntary medical male circumcision (VMMC) service delivery is complex and resource-intensive. In Kenya's context there is still paucity of information on resource use vis-à-vis outputs as programs scale up. Knowledge of technical efficiency, productivity and potential sources of constraints is desirable to improve decision-making.To evaluate technical efficiency and productivity of VMMC service delivery in Nyanza in 2011/2012 using data envelopment analysis.Comparative process evaluation of facilities providing VMMC in Nyanza in 2011/2012 using output orientated data envelopment analysis.Twenty one facilities were evaluated. Only 1 of 7 variables considered (total elapsed operation time) significantly improved from 32.8 minutes (SD 8.8) in 2011 to 30 minutes (SD 6.6) in 2012 (95%CI = 0.0350-5.2488; p = 0.047). Mean scale technical efficiency significantly improved from 91% (SD 19.8) in 2011 to 99% (SD 4.0) in 2012 particularly among outreach compared to fixed service delivery facilities (CI -31.47959-4.698508; p = 0.005). Increase in mean VRS technical efficiency from 84% (SD 25.3) in 2011 and 89% (SD 25.1) in 2012 was not statistically significant. Benchmark facilities were #119 and #125 in 2011 and #103 in 2012. Malmquist Productivity Index (MPI) at fixed facilities declined by 2.5% but gained by 4.9% at outreach ones by 2012. Total factor productivity improved by 83% (p = 0.032) in 2012, largely due to progress in technological efficiency by 79% (p = 0.008).Significant improvement in scale technical efficiency among outreach facilities in 2012 was attributable to accelerated activities. However, ongoing pure technical inefficiency requires concerted attention. Technological progress was the key driver of service productivity growth in Nyanza. Incorporating service-quality dimensions and using stepwise-multiple criteria in performance evaluation enhances comprehensiveness and validity. These findings highlight site-level resource use and sources of variations in VMMC service productivity, which are important for program planning.

Project description:Background Monitoring of superior vena cava saturation (ScvO 2) has become routine in the management of pediatric patients undergoing cardiac surgery. The objective of our study was to evaluate the correlation between continuous ScvO 2 by the application of a fiber-optic oximetry catheter (PediaSat) and intermittent ScvO 2 by using standard blood gas measurements. These results were compared to those obtained by cerebral near infrared spectroscopy (cNIRS).Setting Tertiary pediatric cardiac intensive care unit (PCICU).Methods and main results A retrospective study was conducted in consecutive patients who were monitored with a 4.5 or 5.5 F PediaSat catheter into the right internal jugular vein. An in vivo calibration was performed once the patient was transferred to the PCICU and re-calibration took place every 24 hours thereafter. Each patient had a NIRS placed on the forehead. Saturations were collected every 4 hours until extubation. Ten patients with a median age of 2.2 (0.13-8.5) years and a weight of 12.4 (3.9-24) kg were enrolled. Median sampling time was 32 (19-44) hours: 64 pairs of PediaSat and ScVO2 saturations showed a poor correlation (r=0.62, 95% CI 44-75; p<0.0001) and Bland Altman analysis for repeated measures showed an average difference of 0.34 with a standard deviation of 7,9 and 95% limits of agreement from -15 to 16. Thirty-six pairs of cNIRS and ScVO2 saturations showed a fair correlation (r=0.79, 95% CI 0.60-0.89; p<0.0001) an average difference of -1.4 with a standard deviation of 6 and 95% limits of agreement from -13 to 10. Analysis of median percentage differences between PediaSat and ScvO2 saturation over time revealed that, although not statistically significant, the change in percentage saturation differences was clinically relevant after the 8th hour from calibration (from -100 to +100%).Conclusion PediaSat catheters showed unreliable performance in our cohort. It should be further investigated whether repeating calibrations every 8 hours may improve the accuracy of this system. CNIRS may provide similar results with a lower invasiveness.

Project description:Clinically feasible multiparameter continuous physiological monitoring technologies are needed for use in resource-constrained African healthcare facilities to allow for early detection of critical events and timely intervention for major morbidities in high-risk neonates. We conducted a prospective clinical feasibility study of a novel multiparameter continuous physiological monitoring technology in neonates at Pumwani Maternity Hospital in Nairobi, Kenya. To assess feasibility, we compared the performance of Sibel's Advanced Neonatal Epidermal (ANNE) technology to reference technologies, including Masimo's Rad-97 pulse CO-oximeter with capnography technology for heart rate (HR), respiratory rate (RR), and oxygen saturation (SpO2) measurements and Spengler's Tempo Easy non-contact infrared thermometer for temperature measurements. We evaluated key performance criteria such as up-time, clinical event detection performance, and the agreement of measurements compared to those from the reference technologies in an uncontrolled, real-world setting. Between September 15 and December 15, 2020, we collected and analyzed 503 h of ANNE data from 109 enrolled neonates. ANNE's up-time was 42 (11%) h more for HR, 77 (25%) h more for RR, and 6 (2%) h less for SpO2 compared to the Rad-97. However, ANNE's ratio of up-time to total attached time was less than Rad-97's for HR (0.79 vs 0.86), RR (0.68 vs. 0.79), and SpO2 (0.69 vs 0.86). ANNE demonstrated adequate performance in identifying high and low HR and RR and high temperature events; however, showed relatively poor performance for low SpO2 events. The normalized spread of limits of agreement were 8.4% for HR and 52.2% for RR and the normalized root-mean-square deviation was 4.4% for SpO2. Temperature agreement showed a spread of limits of agreement of 2.8 °C. The a priori-identified optimal limits were met for HR and temperature but not for RR or SpO2. ANNE was clinically feasible for HR and temperature but not RR and SpO2 as demonstrated by the technology's up-time, clinical event detection performance, and the agreement of measurements compared to those from the reference technologies.

Project description:ObjectiveTo assess the feasibility, usability and acceptability of two non-invasive, multiparameter, continuous physiological monitoring (MCPM) technologies for use in neonates within a resource-constrained healthcare setting in sub-Saharan Africa.DesignA qualitative study using in-depth interviews and direct observations to describe healthcare professional and caregiver perspectives and experiences with investigational MCPM technologies from EarlySense and Sibel compared with selected reference technologies.SettingPumwani Maternity Hospital is a public, high-volume, tertiary hospital in Nairobi, Kenya.ParticipantsIn-depth interviews were conducted with five healthcare administrators, 12 healthcare providers and 10 caregivers. Direct observations were made of healthcare providers using the technologies on 12 neonates overall.ResultsDesign factors like non-invasiveness, portability, ease-of-use and ability to measure multiple vital signs concurrently emerged as key themes supporting the usability and acceptability of the investigational technologies. However, respondents also reported feasibility challenges to implementation, including overcrowding in the neonatal unit, lack of reliable access to electricity and computers, and concerns about cost and maintenance needs. To improve acceptability, respondents highlighted the need for adequate staffing to appropriately engage caregivers and dispel misconceptions about the technologies.ConclusionStudy participants were positive about the usefulness of the investigational technologies to strengthen clinical care quality and identification of at-risk neonates for better access to timely interventions. These technologies have the potential to improve equity of access to appropriate healthcare services and neonatal outcomes in sub-Saharan African healthcare facilities. However, health system strengthening is also critical to support sustainable uptake of technologies into routine care.Trial registration numberNCT03920761.

Dataset Information

A feasibility study evaluating a reservoir storage system for continuous oxygen delivery for children with hypoxemia in Kenya.

Background

Methods

Results

Conclusion

Publications

A feasibility study evaluating a reservoir storage system for continuous oxygen delivery for children with hypoxemia in Kenya.

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