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Simultaneous reduction of flow and fraction of inspired oxygen (FiO2) versus reduction of flow first or FiO2 first in patients ready to be weaned from high-flow nasal cannula oxygen therapy: study protocol for a randomized controlled trial (SLOWH trial).
Trials. 2020 Jan 14; 21(1):81.T

Abstract

BACKGROUND

High-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/DESIGN

This 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.

DISCUSSION

This 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 REGISTRATION

ClinicalTrials.gov, NCT03845244. Registered on 19 February 2019.

Authors+Show Affiliations

Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea. Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Republic of Korea.Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea. Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Republic of Korea.Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea. Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Republic of Korea.Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea. Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Republic of Korea.Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea. Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Republic of Korea.Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea. Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Republic of Korea.Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea. Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Republic of Korea.Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea. apolio3700@gmail.com. Department of Hospital Medicine, Seoul National University Bundang Hospital, 82, Gumi-ro 173 Beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, 13620, Republic of Korea. apolio3700@gmail.com.

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

31937322

Citation

Kim, Min Chul, et al. "Simultaneous Reduction of Flow and Fraction of Inspired Oxygen (FiO2) Versus Reduction of Flow First or FiO2 First in Patients Ready to Be Weaned From High-flow Nasal Cannula Oxygen Therapy: Study Protocol for a Randomized Controlled Trial (SLOWH Trial)." Trials, vol. 21, no. 1, 2020, p. 81.
Kim MC, Lee YJ, Park JS, et al. Simultaneous reduction of flow and fraction of inspired oxygen (FiO2) versus reduction of flow first or FiO2 first in patients ready to be weaned from high-flow nasal cannula oxygen therapy: study protocol for a randomized controlled trial (SLOWH trial). Trials. 2020;21(1):81.
Kim, M. C., Lee, Y. J., Park, J. S., Cho, Y. J., Yoon, H. I., Lee, C. T., Lee, J. H., & Kim, E. S. (2020). Simultaneous reduction of flow and fraction of inspired oxygen (FiO2) versus reduction of flow first or FiO2 first in patients ready to be weaned from high-flow nasal cannula oxygen therapy: study protocol for a randomized controlled trial (SLOWH trial). Trials, 21(1), 81. https://doi.org/10.1186/s13063-019-4019-7
Kim MC, et al. Simultaneous Reduction of Flow and Fraction of Inspired Oxygen (FiO2) Versus Reduction of Flow First or FiO2 First in Patients Ready to Be Weaned From High-flow Nasal Cannula Oxygen Therapy: Study Protocol for a Randomized Controlled Trial (SLOWH Trial). Trials. 2020 Jan 14;21(1):81. PubMed PMID: 31937322.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Simultaneous reduction of flow and fraction of inspired oxygen (FiO2) versus reduction of flow first or FiO2 first in patients ready to be weaned from high-flow nasal cannula oxygen therapy: study protocol for a randomized controlled trial (SLOWH trial). AU - Kim,Min Chul, AU - Lee,Yeon Joo, AU - Park,Jong Sun, AU - Cho,Young-Jae, AU - Yoon,Ho Il, AU - Lee,Choon-Taek, AU - Lee,Jae Ho, AU - Kim,Eun Sun, Y1 - 2020/01/14/ PY - 2019/03/26/received PY - 2019/12/20/accepted PY - 2020/1/16/entrez PY - 2020/1/16/pubmed PY - 2020/11/18/medline KW - Adult KW - High-flow nasal cannula KW - Protocol KW - Weaning SP - 81 EP - 81 JF - Trials JO - Trials VL - 21 IS - 1 N2 - BACKGROUND: High-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/DESIGN: This 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. DISCUSSION: This 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 REGISTRATION: ClinicalTrials.gov, NCT03845244. Registered on 19 February 2019. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/31937322/Simultaneous_reduction_of_flow_and_fraction_of_inspired_oxygen__FiO2__versus_reduction_of_flow_first_or_FiO2_first_in_patients_ready_to_be_weaned_from_high_flow_nasal_cannula_oxygen_therapy:_study_protocol_for_a_randomized_controlled_trial__SLOWH_trial__ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-4019-7 DB - PRIME DP - Unbound Medicine ER -