In contemporary clinical practice concerning the administration of inhaled nitric oxide (iNO) within neonatal intensive care units (NICUs), a stepwise reduction approach is frequently employed in accordance with established neonatal guidelines. Nonetheless, the comparative advantages of a linear reduction strategy-characterized by a gradual decrease in inhalation concentration-over the traditional stepwise method in terms of efficacy and safety have yet to be conclusively established. Furthermore, existing iNO delivery devices necessitate that healthcare professionals manually adjust parameters at intervals dictated by the patient's condition. This reliance on subjective clinical judgment often results in variability and a lack of standardization in the duration of the weaning process. Additionally, the protracted and intricate nature of the weaning procedure considerably heightens the workload for healthcare staff. Importantly, the development of a scientifically grounded, standardized, and real-time feedback mechanism for weaning may enhance clinical outcomes for patients and mitigate the risks associated with inappropriate weaning practices or inconsistent manual interventions. Consequently, this study seeks to leverage the newly introduced "intelligent closed-loop weaning" feature of the latest generation of iNO devices to facilitate automated linear concentration reduction during the weaning process. This innovation aims to alleviate the burden on healthcare personnel while establishing a more standardized and scientifically robust weaning protocol. However, it is noteworthy that there is currently a lack of clinical evidence, both domestically and internationally, regarding the safety and efficacy of this device's weaning protocol, underscoring the urgent need to validate its safety and effectiveness in real-world clinical settings.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
The Nitric Oxide Generation and Delivery System is used to deliver nitric oxide for inhalation therapy into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. iNO devices with intelligent closed-loop offline function are required to meet the import and discharge standards. The initial concentration of NO withdrawal is 20ppm. In accordance with the withdrawal criteria outlined in the Chinese Guidelines, it is essential to conduct a comprehensive efficacy evaluation prior to initiating withdrawal. Furthermore, the process of inhaled nitric oxide (iNO) evacuation should commence only if specific conditions are satisfied.
Children's Hospital of Fudan University
Shanghai, China
The occurrence of nitric oxide (NO) rebound hypoxia during the evacuation process
The occurrence of nitric oxide (NO) rebound hypoxia during the evacuation process, operationally defined as the frequency of instances in which peripheral capillary oxygen saturation (SpO2) decreased by more than 5% and the fraction of inspired oxygen (FiO2) increased by 15% in order to maintain partial pressure of arterial oxygen (PaO2) above 60 mmHg (with SpO2 ≥ 90%) during the evacuation of NO
Time frame: Completion of evacuation (expected day 2 of evacuation)
The total duration of inhaled nitric oxide (iNO) evacuation
The entire length of time required to remove or discontinue the use of iNO.
Time frame: Completion of evacuation (expected day 2 of evacuation)
Device Alarm Frequency
The frequency of device alarms recorded during the evacuation process.
Time frame: Completion of evacuation (expected day 2 of evacuation)
NO Concentration Adjustments
The total number of adjustments made to knobs and settings for nitric oxide concentration during evacuation.
Time frame: Completion of evacuation (expected day 2 of evacuation)
Mechanical Ventilation Duration
The duration of mechanical ventilation.
Time frame: Completion of evacuation (expected day 2 of evacuation)
Adverse Events Incidence
The incidence of adverse events associated with nitric oxide treatment.
Time frame: Completion of evacuation (expected day 2 of evacuation)
Complication Rate
The complication rate, specifically focusing on Grade 3-4 intraventricular hemorrhage, intraventricular plasmalacia, moderate to severe bronchopulmonary dysplasia, retinopathy of prematurity necessitating intervention, patent ductus arteriosus requiring either medical or surgical management, pulmonary hemorrhage, and air leak syndrome.
Time frame: Completion of evacuation (expected day 2 of evacuation)
ECMO Utilization Rate
The proportion of cases that required extracorporeal membrane oxygenation (ECMO).
Time frame: Completion of evacuation (expected day 2 of evacuation)
Mortality Rate Before Discharge
The mortality rate prior to discharge.
Time frame: Completion of evacuation (expected day 2 of evacuation)
Healthcare Utilization Preferences
Scores obtained from questionnaires assessing preferences for healthcare utilization.The Likert Scale is used in the questionnaires to measure respondents' attitudes, preferences, or perceptions. It typically ranges from 1 to 5 points, where 1 represents "Strongly Disagree" and 5 represents "Strongly Agree". Respondents select the level that best reflects their opinion, allowing researchers to quantify subjective data and analyze trends effectively.
Time frame: Completion of evacuation (expected day 2 of evacuation)
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