Shrestha Raslina, Mehta Kajal, Dahanayake Dinasha, Yadav Manish, Nakarmi Kiran, Bista Pariwesh, Rai Shankar, Pham Tam, Stewart Barclay T
Department of Burns, Plastics and Reconstructive Surgery, Kirtipur Hospital, Kathmandu, Nepal; Department of General Surgery, Mayo Clinic GSOM, MN, United States.
Department of Surgery, University of Washington School of Medicine, Seattle, WA, United States.
Burns. 2025 Mar;51(2):107347. doi: 10.1016/j.burns.2024.107347. Epub 2024 Dec 27.
Enterally-based resuscitation (EResus) is safe, efficacious, and has operational advantages, particularly in low-resource settings. However, there is a lack of real-world effectiveness studies and evidence-based protocols, which hinders implementation. To address this gap, we conducted a feasibility study ahead of a randomized controlled trial (RCT) of enterally based versus usual resuscitation at a tertiary burn center in Nepal which had no prior clinical trial experience. We aimed to assess the feasibility of conducting collaborative and prospective clinical research in this setting, the acceptability of the intervention, and compliance with the resuscitation and study protocols.
We enrolled and randomized 30 participants. We collected quantitative and qualitative data from participants via resuscitation flowsheets (n = 30), along with in-depth interviews conducted before and after resuscitations with participants (n = 12) and providers (n = 45). Evidence of the capabilities to perform the trial as designed, the acceptability of the intervention, and compliance with the study and resuscitation protocols was identified and described through systematic evaluations of recruitment efficiency, protocol adherence, data collection accuracy, high patient consent rates, and detailed feedback collected through in-depth interviews with participants and providers.
We demonstrated successful research collaboration through the maintenance of weekly study meetings, real-time WhatsApp communication, and funding that allowed for sustainable infrastructure development in Nepal. Screening of 562 burn patients resulted in 33 eligible participants, with a high acceptance rate, as 30 consented to enroll (91 % consent rate). The trial achieved high fidelity in resuscitation protocols, with 93 % adherence to the prescribed enteral resuscitation volumes. No participant dropped out during the study period, indicating strong retention and protocol adherence.
This study established the feasibility of performing a randomized trial in a low-resource context with no prior trial experience. Enterally-based resuscitation is an acceptable and favored intervention with a high rate of enrollment. Hospital staff were able to follow the study and resuscitation protocols with high fidelity, though some optimization was requested. With this evidence of feasibility, the trial will continue enrollment, and the future data may provide valuable insights for advancing burn resuscitation in low-resource settings.
基于肠内途径的复苏（EResus）安全、有效，且具有操作优势，在资源匮乏地区尤为如此。然而，缺乏实际效果研究和循证方案阻碍了其实施。为填补这一空白，我们在尼泊尔一家此前没有临床试验经验的三级烧伤中心，于一项对比基于肠内途径复苏与常规复苏的随机对照试验（RCT）之前开展了一项可行性研究。我们旨在评估在此环境下开展协作性前瞻性临床研究的可行性、干预措施的可接受性以及对复苏和研究方案的依从性。
我们招募了30名参与者并进行随机分组。我们通过复苏流程表（n = 30）收集参与者的定量和定性数据，同时在复苏前后对参与者（n = 12）和医护人员（n = 45）进行深入访谈。通过对招募效率、方案依从性、数据收集准确性、高患者同意率以及通过对参与者和医护人员的深入访谈收集的详细反馈进行系统评估，确定并描述了按设计开展试验所需的能力、干预措施的可接受性以及对研究和复苏方案的依从性的证据。
我们通过维持每周的研究会议、实时WhatsApp沟通以及为尼泊尔可持续基础设施发展提供资金，展示了成功的研究合作。对562名烧伤患者进行筛查后，有33名符合条件的参与者，接受率很高，因为有30名同意入组（同意率为91%）。该试验在复苏方案方面实现了高保真度，93%的患者依从规定的肠内复苏量。在研究期间没有参与者退出，表明保留率高且方案依从性好。
本研究确立了在没有先前试验经验的资源匮乏环境中进行随机试验的可行性。基于肠内途径的复苏是一种可接受且受欢迎的干预措施，入组率高。医院工作人员能够高度忠实地遵循研究和复苏方案，但仍有一些优化需求。有了这一可行性证据，该试验将继续招募患者，未来的数据可能为在资源匮乏地区推进烧伤复苏提供有价值的见解。
