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临床试验/NCT07465055
NCT07465055进行中(未招募)不适用

Impact of Operating Room Extubation on Postoperative Outcomes in Neonates Undergoing Meningomyelocele Repair: A Retrospective Cohort Study

Gaziantep City Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年11月1日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
60
试验地点
1
主要终点
Postoperative Mechanical Ventilation Requirement

研究概览

简要总结

Meningomyelocele is one of the most common neural tube defects requiring surgical repair in the neonatal period. Postoperative respiratory complications and the need for prolonged mechanical ventilation are important causes of morbidity in these patients. The timing of extubation may influence postoperative respiratory outcomes and the duration of neonatal intensive care unit (NICU) stay. This retrospective cohort study aims to evaluate the impact of operating room extubation on postoperative outcomes in neonates undergoing meningomyelocele repair at Gaziantep City Hospital. Clinical, laboratory, and perioperative data will be obtained from hospital records. Postoperative mechanical ventilation requirement, duration of ventilation, NICU length of stay, and perioperative laboratory changes will be compared between neonates extubated in the operating room and those extubated in the intensive care unit.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
0 Days 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Neonates undergoing surgical repair of meningomyelocele
  • Surgery performed under general anesthesia
  • Age ≤ 28 days at the time of surgery
  • Postoperative follow-up in the neonatal intensive care unit (NICU)
  • Availability of complete perioperative clinical and laboratory data

排除标准

  • Preoperative respiratory distress requiring invasive or non-invasive ventilatory support
  • Major congenital anomalies or severe comorbidities (e.g., complex congenital heart disease, severe pulmonary disease, chromosomal abnormalities)
  • Neonates with poor postnatal adaptation (5-minute Apgar score < 7)
  • Preoperative hemodynamic instability
  • Severe prematurity-related respiratory morbidity
  • Prolonged mechanical ventilation due to causes unrelated to meningomyelocele surgery
  • Incomplete or missing perioperative medical records

研究组 & 干预措施

Operating Room Extubation

Neonates who were extubated in the operating room immediately after meningomyelocele repair.

ICU Extubation

Neonates who were transferred intubated to the NICU and extubated in the intensive care unit after meningomyelocele repair.

结局指标

主要结局

Postoperative Mechanical Ventilation Requirement

时间窗: Within the first 48 hours after surgery

Requirement for invasive mechanical ventilation after meningomyelocele repair in neonates.

次要结局

  • Length of NICU Stay(From surgery until discharge from the neonatal intensive care unit, up to 30 days)
  • Change in Blood pH(Preoperative vs postoperative 24 hours)
  • Change in Lactate Level(Baseline (preoperative) and 24 hours after surgery)

研究者

发起方
Gaziantep City Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Recep Karakaşoğlu

Specialist in Anesthesiology and Reanimation

Gaziantep City Hospital

研究点 (1)

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