A Descriptive Prospective Study of Diaphragmatic Activity in Intubated Neonates Around Extubation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Extubation success
研究概览
简要总结
The objective of this study is to evaluate the role of diaphragmatic electrical activity monitoring (collected by esophageal probe) around extubation of preterm patients in order to consider its use as a standardized objective criterion to aid in the decision to extubate.
详细描述
All parents of newborns meeting the inclusion criteria and without exclusion criteria will be approached for the study. If the parents do not object, the investigators will include patients once a collegial decision to extubate has been made after re-verification of the inclusion/exclusion criteria.
After patient inclusion, patient data collection by Servo-tracker will be set up, and ancillary data (treatments, Neo Comfort scale, respiratory rate, transcutaneous capnography, ventilation parameters, tidal volume) will be recorded at a given time every hour until the patient is extubated.
At the same time, the investigators will extract medical and administrative data from the patients' electronic records into a database that can only be accessed on a department computer, protected by a password.
After extubation, the patient is monitored for 7 days to assess the need for reintubation and collect data if the patient is reintubated. At the end of the 7 days or after reintubation, the patient's study follow-up is complete.
They may be included again if they are extubated again during the study period.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Days 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All newborns born at <32 weeks of amenorrhea hospitalized in the neonatal intensive care unit at CHIC
- •Patient intubated and ventialted with an Edi tube in place
- •Patient eligible for scheduled extubation
排除标准
- •Absence of Edi tube
- •Palliative care situation
- •Patient treated with curare
- •Patients with neuromuscular disorders
- •Accidental extubation
- •Parental refusal
结局指标
主要结局
Extubation success
时间窗: 7 days
Comparaison with patients who experience extubation failure. Focusing on clinical, therapeutic, and ventilatory data. In particular data extracted by the servo-tracker software (collected from the time the software is installed on the ventilator following the decision to extubate until the actual extubation): * Maximum, minimum, and average EDI over the period * Tidal volume: maximum, minimum, and average over the period * Inspiratory time: maximum, minimum, and average over the period * Total time between the decision to extubate and the actual extubation This data will be used to calculate: * Neuro-mechanical efficiency: Mean tidal volume / Mean EDI max * Variability of the EDI max signal: its standard deviation * Respiratory variability: standard deviation of tidal volume
次要结局
- Time to reintubation(7 days)
- Reintubation rate(7 days)
研究者
Xavier Durrmeyer, MD
Coordonnateur
Centre Hospitalier Intercommunal Creteil