Abstract
BackgroundHigh-flow nasal cannula (HFNC) oxygen therapy has been widely used in critically ill patients. Despite the effectiveness of HFNC as a treatment, optimal methods to withdraw HFNC after recovery from preexisting conditions have not been investigated to date. In this study, we will evaluate the safety and efficacy of simultaneous reduction of flow and fraction of inspired oxygen (FiO2) compared with sequential reduction of either flow first or FiO2 reduction first in patients with HFNC.Methods/designThis is a prospective, investigator-initiated, randomized controlled trial with three experimental intervention groups. A total of 100 adult patients receiving HFNC and satisfying weaning criteria will be enrolled and randomly assigned to one of the following groups: flow reduction (FR) first, FiO2 reduction (OR) first, or simultaneous reduction (SR). In the FR group, flow will be reduced first by 10 L/min/h. When it reaches 20 L/min, FiO2 will then be reduced by 0.1 /h until it reaches 0.3. In the OR group, the FiO2 will be gradually reduced first by 0.1 /h until it reaches 0.3, then flow will be reduced by 10 L/min until it reaches 20 L/min. Finally, in the SR group, both the flow and FiO2 will be gradually reduced simultaneously by 10 L/min and 0.1/h, respectively. Weaning will proceed only when patients satisfy the weaning criteria at every weaning point. When the HFNC weaning-off targets are reached (20 L/min and 0.3 for flow and FiO2, respectively), the patient will be transferred to conventional oxygen therapy (mainly low-flow nasal prongs). The primary outcome is the time to successful weaning from HFNC for 24 h. Secondary outcomes will include the success or failure rate in weaning off HFNC and changes in arterial blood gas analyses, intolerance rate, length of hospital stay, and in-hospital mortality.DiscussionThis study will be the first clinical trial to investigate the safety and efficacy of three different methods of weaning in adult patients receiving HFNC. Once this study is completed, we expect to be able to suggest the better strategy for withdrawal of HFNC based on the results.Trial registrationClinicalTrials.gov, NCT03845244. Registered on 19 February 2019.
Highlights
High-flow nasal cannula (HFNC) oxygen therapy has been widely used in critically ill patients
Once this study is completed, we expect to be able to suggest the better strategy for withdrawal of HFNC based on the results
Numerous well-designed studies have been conducted into the use of the HFNC in the treatment of critically ill patients, and HFNC is widely used in the treatment of patients with various diagnoses including acute hypoxemic respiratory failure or acute respiratory distress syndrome (ARDS) [5, 6], and is used in post-extubation treatment [7,8,9], post-cardiothoracic surgery respiratory distress [10, 11], and respiratory compromise induced by heart failure [12, 13]
Summary
We considered a study design that would minimize the risk to the patients. In contrast to immediate withdrawal, stepwise weaning may minimize atelectotrauma and gradually increase respiratory muscle strength without the associated risk of atelectasis. After completion of the study, we hope to be able to suggest the best strategy for the withdrawal of the HFNC in adult patients. There are several strengths of this study design This will be the first study to evaluate HFNC weaning strategies in an adult population. It has been designed as a prospective RCT, which is one of the most powerful study designs. Trial status Protocol version 1.0 (approval date 12 November 2018) This trial started recruiting in January 2019.
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