Impact of different weaning strategies of high-frequency ventilation (HFV) on neonatal cerebral oxygen saturation and hemodynamics: protocol for a prospective randomized controlled trial.

Autor: Liu W; Department of Pediatrics, West China Second University Hospital, Sichuan University, No. 20, Section Three, South Renmin Road, Chengdu, China., Xiong T; Department of Pediatrics, West China Second University Hospital, Sichuan University, No. 20, Section Three, South Renmin Road, Chengdu, China. tao_xiong@126.com.; Key Laboratory of Birth Defects and Related Diseases of Women and Children, Ministry of Education, Sichuan University, Chengdu, China. tao_xiong@126.com., Tang J; Department of Pediatrics, West China Second University Hospital, Sichuan University, No. 20, Section Three, South Renmin Road, Chengdu, China.; Key Laboratory of Birth Defects and Related Diseases of Women and Children, Ministry of Education, Sichuan University, Chengdu, China., Shi J; Department of Pediatrics, West China Second University Hospital, Sichuan University, No. 20, Section Three, South Renmin Road, Chengdu, China.; Key Laboratory of Birth Defects and Related Diseases of Women and Children, Ministry of Education, Sichuan University, Chengdu, China., Chen C; Department of Pediatrics, West China Second University Hospital, Sichuan University, No. 20, Section Three, South Renmin Road, Chengdu, China., Huang Y; Department of Pediatrics, West China Second University Hospital, Sichuan University, No. 20, Section Three, South Renmin Road, Chengdu, China., Tian K; Department of Pediatrics, West China Second University Hospital, Sichuan University, No. 20, Section Three, South Renmin Road, Chengdu, China., Zhou R; Department of Pediatrics, West China Second University Hospital, Sichuan University, No. 20, Section Three, South Renmin Road, Chengdu, China., Yuan Z; Department of Pediatrics, West China Second University Hospital, Sichuan University, No. 20, Section Three, South Renmin Road, Chengdu, China., Wang A; Department of Pediatrics, West China Second University Hospital, Sichuan University, No. 20, Section Three, South Renmin Road, Chengdu, China., Zhu J; Department of Pediatrics, West China Second University Hospital, Sichuan University, No. 20, Section Three, South Renmin Road, Chengdu, China.
Jazyk: angličtina
Zdroj: Trials [Trials] 2024 Nov 14; Vol. 25 (1), pp. 765. Date of Electronic Publication: 2024 Nov 14.
DOI: 10.1186/s13063-024-08621-9
Abstrakt: Background: High-frequency ventilation (HFV) is commonly used in neonatal intensive care units to provide respiratory support for critically ill neonates. Currently, there is no standardized procedure for weaning from HFV. Two commonly used strategies are transitioning from HFV to conventional mechanical ventilation (CMV) before extubation (HFV-CMV) and extubation after decreasing mean airway pressure during HFV (HFV-HFV). The impact of these strategies on neonatal cerebral oxygenation and hemodynamics remains incompletely understood.
Methods: We will conduct a prospective, single-center, randomized controlled trial to investigate the effects of two different HFV weaning strategies (HFV-CMV, HFV-HFV) on neonatal cerebral oxygenation and hemodynamics. The patients enrolled in the trial will be randomly allocated to either the HFV-CMV group or the HFV-HFV group in a 1:1 ratio. The primary outcome will be cerebral oxygen saturation (S c O 2 ) before and after the intervention. Second outcomes are cerebral fractional tissue oxygen extraction, heart rate, blood pressure, and the incidence and severity of intraventricular hemorrhage and periventricular leukomalacia. We hypothesize that HFV-CMV results in positive impact on neonatal cerebral oxygenation compared to HFV-HFV. This study aims to identify a better weaning strategy for HFV and contribute evidence-based data to enhance its clinical application in newborns, potentially improving the care and outcomes for neonates receiving HFV.
Discussion: This study aims to assessing the impact of different HFV weaning strategies on neonatal cerebral oxygenation and hemodynamics, as well as the relationship between the duration of HFV under different strategies and neurological complications, to identify better weaning methods for HFV. We hope to contribute evidence-based data to enhance clinical application of HFV in newborns, potentially improving the care and outcomes for neonates receiving HFV.
Trial Registration: Chinese Clinical Trial Registry: ChiCTR2400088628. Registered on August 22, 2024, https://www.chictr.org.cn/bin/project/edit?pid=235926 .
Competing Interests: Declarations Ethics approval and consent to participate {24} This study has been approved by the Ethics Committee of West China Second University Hospital of Sichuan University, with the approval number of 2024 (130). Written, informed consent to participate will be obtained from the parent or legal guardian of the neonates participating in the trial. Consent for publication {32} Not applicable. This manuscript does not contain individual personal data from patients. The participant information materials and informed consent form are available from the corresponding author on request. Competing interests {28} The authors declare that they have no competing interests.
(© 2024. The Author(s).)
Databáze: MEDLINE
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