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临床试验/2023-508120-35-00
2023-508120-35-00已完成4 期

Impact on gastric emptying measured by antral gastric ultrasound of erythromycin administration in stroke patients with indication for mechanical thrombectomy.

Hospital Foch1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2024年2月9日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
84
试验地点
1
主要终点
The primary endpoint will be the percentage reduction in antral surface area between the initial antral ultrasound and the antral ultrasound after the thrombectomy procedure in the neuroradiology unit.

研究概览

简要总结

To evaluate the efficacy of erythromycin IVSE on decreasing antral surface area by emergency mechanical thrombectomy procedure in patients with ischemic stroke.

入排标准

年龄范围
18 years 至 65+ years(18-64 Years, 65+ Years)
接受健康志愿者

入选标准

  • Major patients with ischemic stroke
  • Requiring emergency interventional neuroradiology for mechanical thrombectomy for stroke, regardless of anesthetic procedure (AG or AL)
  • Informed consent obtained from the patient/relative or following an emergency procedure.
  • Being affiliated to a health insurance plan

排除标准

  • Pregnant woman
  • Deprived of liberty or under tutelage
  • Allergy to macrolides, curares (succinylcholine, rocuronium)
  • Nasogastric tube placement prior to interventional radiology admission
  • Patient already intubated on arrival
  • Minor or protected adult
  • Contraindication to erythromycin administration: known allergy, hepatic porphyria
  • Scheduled return trip, within less than 24 hours, to a neurology department outside Hôpital Foch

结局指标

主要结局

The primary endpoint will be the percentage reduction in antral surface area between the initial antral ultrasound and the antral ultrasound after the thrombectomy procedure in the neuroradiology unit.

The primary endpoint will be the percentage reduction in antral surface area between the initial antral ultrasound and the antral ultrasound after the thrombectomy procedure in the neuroradiology unit.

次要结局

  • The frequency and proportion of patients randomized into the study after the first antral ultrasound for full stomach (with an ultrasonographic antral surface area > 340 mm2). The frequency and proportion of patients not randomized in the study (with an ultrasonographic antral surface < 340 mm2).
  • The proportion of patients with a 30% reduction in antral surface area between the measurement taken at the start of the procedure and that taken at the end of the procedure.
  • The frequency and proportion of patients with an ultrasound anal surface area < 340 mm2 at the end of the procedure.
  • Frequency and proportion of patients for whom ultrasound information had an influence (particularly knowledge of a full stomach) on anesthetic management strategy, as reported by the investigator: change in anesthetic strategy (Yes/No), decision to use orotracheal intubation (Yes/No), decision to place a nasogastric tube (Yes/No).
  • In patients who can benefit from an elevated head position after revascularization, digital measurements of the antral area and determination of the PERLAS score in strict dorsal recumbency followed by 45° proclivity.
  • Calculation of gastric volume in mm3 from antral surface measured in lateral decubitus position
  • The frequency and proportion of complications typically encountered during thrombectomy procedures: hypotension, desaturation, need to increase oxygen flow, difficult upper airway management, inhalation syndrome.
  • During the hospital stay: use of oxygen therapy at H+4 (Yes/No), possible post-procedure transfer to intensive care (Yes/No), occurrence of serious and non-serious adverse events related to erythromycin administration (Yes/No).

研究者

发起方
Hospital Foch
申办方类型
Hospital/Clinic/Other health care facility
责任方
Principal Investigator
主要研究者

Sahar Sellami Jallouli

Scientific

Hospital Foch

研究点 (1)

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