John Midhun Thomas, van Blydenstein Sarah Alexandra, Omar Shahed, Bruins Joanne, Tshukutsoane Stephilia
Internal Medicine Registrar, Chris Hani Baragwanath Hospital, Internal Medicine, University of Witwatersrand, South Africa.
Specialist Pulmonologist, Chris Hani Baragwanath Hospital, Internal Medicine, University of Witwatersrand, South Africa.
Afr J Emerg Med. 2022 Sep;12(3):172-176. doi: 10.1016/j.afjem.2022.03.003. Epub 2022 May 20.
Severe Coronavirus Disease 2019 (COVID-19) can develop pneumonia with severe complications. The Oxygen Efficient Respiratory Aid (OxEra) device has been granted SAPHRA approval for emergency COVID-19 pandemic use. The device has the potential to be used widely in the healthcare sector due to its efficient oxygen supply and adjustable wall positive expiratory pressure (PEP).
We assessed whether the OxEra device was safe to use in a healthy adult volunteer population. Our primary objective was to ensure there was no asphyxiation, as assessed by changes observed from baseline End Tidal Carbon Dioxide (ETCO) exceeding 6.3 mmHg and above the 45 mmHg threshold. We also monitored changes in vital organ signs and assessed the pain and comfort of the participant at various intervals with changes in PEPs.
This was an experimental safety study of the OxEra Device on 30 healthy participants at the ICU training centre of Chris Hani Baragwanath Academic Hospital, Johannesburg, South Africa. Each participant had basic vital-signs, ETCO, and Oxygen saturation percentages (SpO%) taken at baseline until the end of 2 h. In the first 20 min, the PEP was increased by 5 cmH0 until 20 min, then continued for the rest of the time on a PEP of 5 cmH0. At each interval, vital signs, subjective comfort, pain, and visual scores were measured.
Thirty healthy participants were enrolled. There was no significant difference in ETCO from baseline until 2 h. No participant experienced an increase in measured ETCO greater than 45 mmHg and no increase in ETCO from baseline was greater than 6.3 mmHg. The median increase in ETCO over the study period was 2 mmHg. There were no significant changes in respiratory rate and blood pressure. The heart rate decreased significantly (73-68 bpm). The VAS and comfort score had a significant increase over the 2 h from baseline of 0-2 at maximum; however, the PAS scores showed no significant increase.
Overall the OxEra device achieved the safety endpoints set out. There was no sign of asphyxiation and there were appropriate physiological responses to changes in PEP once applied. The comfort of the mask did worsen over the 2 h; however, the scores were minimally worse on PEP application but improved once-off PEP. No adverse event was recorded at all.
2019年冠状病毒病（COVID-19）重症患者可发展为伴有严重并发症的肺炎。高效氧合呼吸辅助（OxEra）设备已获得南非卫生产品监管局（SAPHRA）批准，可在COVID-19大流行期间紧急使用。由于其高效的氧气供应和可调节的呼气末正压（PEP），该设备有潜力在医疗保健领域广泛应用。
我们评估了OxEra设备在健康成年志愿者群体中使用是否安全。我们的主要目标是确保不会发生窒息，这通过观察到的呼气末二氧化碳（ETCO）从基线变化超过6.3 mmHg且高于45 mmHg阈值来评估。我们还监测了重要器官体征的变化，并在不同时间间隔随着PEP的变化评估参与者的疼痛和舒适度。
这是一项在南非约翰内斯堡克里斯·哈尼·巴拉干纳特学术医院重症监护培训中心对30名健康参与者进行的OxEra设备实验性安全性研究。在基线时直至2小时结束，对每位参与者测量基本生命体征、ETCO和血氧饱和度百分比（SpO%）。在最初20分钟内，PEP每20分钟增加5 cmH₂O，然后在剩余时间内保持在5 cmH₂O的PEP水平。在每个时间间隔，测量生命体征、主观舒适度、疼痛和视觉评分。
招募了30名健康参与者。直至2小时，ETCO与基线相比无显著差异。没有参与者的测量ETCO增加超过45 mmHg，且ETCO较基线的增加没有超过6.3 mmHg。研究期间ETCO的中位数增加为2 mmHg。呼吸频率和血压没有显著变化。心率显著下降（从73次/分钟降至68次/分钟）。视觉模拟评分（VAS）和舒适度评分在2小时内从基线的最高为0 - 2显著增加；然而，疼痛评分（PAS）没有显著增加。
总体而言，OxEra设备达到了设定的安全终点。没有窒息迹象，并且在应用PEP后对其变化有适当的生理反应。口罩的舒适度在2小时内确实变差；然而，在应用PEP时评分只是略有变差，但一次性应用PEP后有所改善。未记录到任何不良事件。
