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临床试验/NCT06249659
NCT06249659已完成不适用

Impact of Extubation Location After Surgery on Perioperative Times. A Prospective Multicenter Observational Study. Extub_Loca Study

University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 756 人开始时间: 2020年9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
756
试验地点
1
主要终点
Additional operative room occupancy time associated with awakening and extubation

研究概览

简要总结

The additional time required to awaken a patient is one of the main reasons for not extubating him or her in the operating room (OR). Conversely, transferring an intubated patient to recovery room (RR), prolonging the duration of anesthesia and intubation, in a limited environment in human resources, may lead to increased complications' rates. Little is known about those time lengths and complications rates.

详细描述

The additional time required to awaken a patient is one of the main reasons for not extubating him or her in the operating room (OR). Conversely, transferring an intubated patient to recovery room (RR), prolonging the duration of anesthesia and intubation, in a limited environment in human resources, may lead to increased complications' rates. Little is known about those time lengths and complications rates. The primary objective was to evaluate the additional OR occupancy time associated with awakening and extubation. Secondary objectives were to assess the rate of post-extubation complications and the need for ventilatory support. This was a prospective multicenter observational study involving intubated patients who underwent surgeries in the operating theatres of the Montpellier and Clermont-Ferrand university hospitals. Anesthesia teams were asked to complete a form including data related to the patient, surgical procedure, anesthesia procedure (induction and recovery) and the occurrence of any complications during the procedure. A multivariate analysis was conducted on the full cohort, using a propensity score (IPTW, inverse probability of treatment weighting) to account for imbalances between groups.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • Adult (older than 18 years old)
  • Patients admitted to any operative room of participating centre for a surgical or endoscopic procedure under general anaesthesia requiring endo-tracheal intubation
  • Subjects must be covered by public health insurance
  • Written informed consent from the patient or proxy (if present) before inclusion or once possible when patient has been included in a context of emergency.

排除标准

  • Patient extubated in intensive care unit
  • Patient extubated during on-call hours (because of a reduced number of medical and paramedical staff)
  • Patient extubated following cardiac surgery
  • Refusal of study participation or to pursue the study by the patient
  • Absence of coverage by the French statutory healthcare insurance system
  • Protected person

结局指标

主要结局

Additional operative room occupancy time associated with awakening and extubation

时间窗: From end of procedure until extubation, assessed up to 2 hours

Time between dressing application (or end of procedure if there was no cutaneous effraction) and discharge from the OR

次要结局

  • Reported post-operative pulmonary complications_Day7(Seven first postoperative days)
  • Time from the end of the surgical procedure (closure of surgical site and dressing placement) to extubation(From end of procedure until extubation, assessed up to 2 hours)
  • Time from the end of anaesthesia drug administration to extubation(From end of anesthesia drug administration until extubation, assessed up to 2 hours)
  • Time from the end of the surgical procedure to patient able to be transferred to the ward (as defined by an Aldrete score above 10)(From end of procedure until discharge to surgical ward, assessed up to 6 hours)
  • Impact of sequencing of operating programme in the room concerned on extubation location(From end of procedure until next procedure in the same room, assessed up to one day)
  • Incidence of oxygen support requirement_Day-1(First postoperative day)
  • Oxygen therapy_PACU(From end of procedure until discharge to surgical ward, assessed up to 6 hours)
  • Bradycardia_PACU(From end of procedure until discharge to surgical ward, assessed up to 6 hours)
  • Reversal_NMBA(From end of anesthesia until extubation, assessed up to 2 hours)
  • Hypotension_PACU(From end of procedure until discharge to surgical ward, assessed up to 6 hours)
  • Drugs_opioids(Perioperative)
  • Hypoxemia_PACU(From end of procedure until discharge to surgical ward, assessed up to 6 hours)
  • NMBA_PACU(From end of procedure until discharge to surgical ward, assessed up to 6 hours)
  • Loco-regional anaesthetic technique(Perioperative)
  • Drugs_neuromuscular blocking agents(Perioperative)
  • Drugs_hypnotics(Perioperative)
  • Drugs_adjuvant analgesics(Perioperative)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (1)

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