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临床试验/NCT05502926
NCT05502926已完成不适用

Perioperative Lung Ultrasound Score (LUS) for Prediction of Postoperative Pulmonary Complications (PPC)

Moshe Rucham MD1 个研究点 分布在 1 个国家目标入组 163 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
163
试验地点
1
主要终点
post operative oxygen treatment

研究概览

简要总结

Patients undergoing surgery inside their abdomen, with no serious heart or lung diseases, will have a lung ultrasound exam before and after surgery. The patient respiratory status in the post-operative unit and the surgical ward will be monitored for complications after surgery

详细描述

The study will be performed in the Soroka hospital operating room and recovery unit.

On admission to pre-surgery, patients will be investigates for inclusion and exclusion criteria. Those that are eligible for the study will be asked to give formal consent to participate in the study. After consent the examiner will review the patient's past medical history and surgery plan, and will preform the pre-operative LUS exam.

After surgery, the examiner will review the electronic anesthesia record and will preform the post-operative LUS exam within 30 minutes of arrival to the recovery unit or 30 minutes from extubation (in patients that were admitted to the recovery unit still under mechanical ventilation). Upon discharge from the recovery unit the examiner will review the recovery unit electronic record.

After discharge, the examiner will review the patient post-operative surgical ward electronic record.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The population study will include patients 18 years and older, with ASA class I, II or III, presenting for elective intra-abdominal surgery under general anesthesia and are not planned for long-term post-surgical mechanical ventilation.

排除标准

  • Patient will be excluded from the study if they have pre-existing moderate or severe heart or lung disease: a history of ischemic heart disease, moderate or severe systolic or diastolic heart failure, moderate or severe pulmonary hypertension, moderate or severe obstructive or interstitial lung disease. Patients will also be excluded if they had a severe intra-operative pulmonary complication (laryngospasm, bronchospasm, anaphylaxis, emergency surgical airway). Patients who require un-planned long term mechanical ventilation or those who died during surgery will also be excluded.

结局指标

主要结局

post operative oxygen treatment

时间窗: 48 hours

any kind of oxygen therapy (face mask, nasal cannula, CPAP/BIPAP) more then 12 hours after and of surgery, or desaturation \<90%

icu admission / reintubation

时间窗: during hospital stay

unplanned postoperative admission to icu or re-intubation

death

时间窗: 48 hours

postoperative death of any cause

postoperative pneumonia

时间窗: 48 hours

clinical or radiographic diagnosis of pneumonia

次要结局

  • PACU oxygen therapy(during hospital stay)
  • PACU stay(during hospital stay)
  • PACU discharge oxygen therapy(during hospital stay)

研究者

发起方
Moshe Rucham MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Moshe Rucham MD

Principal Investigator

Soroka University Medical Center

研究点 (1)

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