Feasibility of a randomized controlled trial of enteral vs intravenous resuscitation for adults with major burn injuries in Nepal

Abstract

Introduction

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.

Methods

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.

Results

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.

Conclusion

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.