跳至主要内容
临床试验/NCT03802643
NCT03802643Unknown不适用

Assessment of Oxygenation Values Before General Anesthesia in Elective Surgery

University of Parma1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2018年12月20日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,000
试验地点
1
主要终点
Evaluation of preoxygenation use in elective surgery, reporting oxygenations values

研究概览

简要总结

Rationale of the study: we aim to clarify the question (related to still unclear and not univocal response) about the protective or unnecessary role of preoxygenation in non-critically ill patients (otherwise with no high risk of desaturation) undergoing general anesthesia before elective surgery.

It will be also necessary differentiate the development of postoperative complications (pulmonary, cardiovascular, neurological, surgical) due to preoxygenation from the ones related with patient comorbidity, intraoperative and surgical causes, tube disconnection.

Procedure: patient's informed consent signature for adhesion at the study will be initially requested. With their acceptance, parameters will be recorded anonymously in the Case Report Form, identified by their initials and an alphanumeric code, until hospital discharge.

The parameters analyzed will be related to:

  • preoperative evaluation; about anamnesis, health general conditions, blood oxygen saturation (Sat02), Metabolic Equivalent of Task (METs)
  • intraoperative evaluation; about oxygenations values, recorded before/during induction and maintenance of general anesthesia
  • postoperative evaluation; about postoperative complications, pulmonary primarily, and secondary cardiovascular, neurological and surgical, based on the medical record.

The data wil be transferred on Excel worksheet, utilized for descriptive analysis related at every variable. By multivariate logistic regression will be evaluated the major factors influencing postoperative pulmonary complications (PPCs) onset in patients undergoing preoxygenation for elective surgery

详细描述

Background of the study:

Preoxygenation is a widely used technique that improves the safety of endotracheal intubation. The procedure is carried out by supplying 100% oxygen (FiO2 of 1.0) before the induction of general anesthesia until both end-tidal oxygen (EtO2)>90% and end-tidal N2 (EtN2)<5% are reached. Both these markers define the efficacy of the procedure. As a result, the lung oxygen content is increased far beyond normal oxygen consumption by saturating the functional residual capacity with 100% oxygen. This allows for a longer safe apnea time (i.e. the time required for oxyhemoglobin saturation to drop below 90%). The rate at which oxyhemoglobin saturation drops during apnea indicates the efficiency of the maneuver.

This procedure is strongly recommended for all patients undergoing general anesthesia since it lengthens safe laryngoscopy time and grants a wider timeframe to respond to a "cannot intubate/cannot oxygenate" (CICO) scenario, a rare yet life threatening situation. It remains unclear whether this should be considered mandatory for non-critically ill and non-obese patients since their oxygen reserves should suffice for the time required to perform endotracheal intubation or regain spontaneous breathing in the event of a CICO scenario. Nonetheless, the guidelines for the management of endotracheal intubation, proposed by the Difficult Airway Society in 2015 United Kingdom state how it is pivotal to preoxygenate every patient before attempting to intubate. Several methods of preoxygenation have been validated and compared according to duration of safe apnea time, duration of the procedure, success rate (defined as "avoiding manual re-ventilation"), and patient tolerance. The choice between these techniques is based on patient characteristics (age, sex, Body Mass Index, American Society of Anesthesiologist score, Cormack-Lehane grade and Glasgow Coma Scale), settings (e.g., operating room, Intensive Care Unit, emergency situations), equipment, and anesthesiologist's preferences. The two standard approaches are six deep breaths in 1 min and tidal volume breathing for three to 5 min, both at 100% inspired oxygen via a face mask.

The main side effect of preoxygenation is absorption atelectasis that occurs when delivering 100% inspired oxygen. This can be avoided using a lower inspired oxygen concentration (90%), positive pressure techniques, and/or recruitment maneuvers post-endotracheal intubation. Due to the short duration of the procedure, the production of reactive oxygen species and cardiovascular responses are minimal and should not prevent routine preoxygenation.

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
否

入选标准

  • •informed consent signature
  • •eligible for preoxygenation before general anesthesia, in elective surgery
  • •age > 18 years
  • •surgery duration > 30 min

排除标准

  • •emergency/urgent surgery
  • •severe respiratory disease: Chronic Obstructive Pulmonary Disease stages III-IV, pulmonary fibrosis, documented bullous emphysema, severe emphysema, pneumothorax
  • •uncontrolled asthma
  • •severe cardiac disease: Heart Failure stages III-IV (New York Heart Association), coronary artery disease stages III-IV (Canadian Cardiovascular Society)
  • •previous thoracic surgery
  • •pregnancy (excluded by anamnesis or laboratory test)
  • •informed consent refusal

结局指标

主要结局

Evaluation of preoxygenation use in elective surgery, reporting oxygenations values

时间窗: From before induction of general anesthesia until the end of surgical procedure, up to 10 hours

Assessment of its efficacy and efficiency in non-critically ill patients, reporting blood oxygen levels just before induction, during induction and maintenance of general anesthesia

Incidence of postoperative pulmonary complications (PPC) related to preoxygenation

时间窗: From immediately after surgery until hospital discharge, up to 26 weeks

Differentiating PPCs due to preoxygenation from the ones related with patient comorbidity, intraoperative and surgical causes, tube disconnection

次要结局

  • Incidence of intraoperative desaturation/hypoxia(From achieved endotracheal intubation until the end of surgical procedure, up to 10 hours)
  • Incidence of cardiovascular postoperative complications(From immediately after surgery until hospital discharge, up to 26 weeks)
  • Incidence of neurological postoperative complications(From immediately after surgery until hospital discharge, up to 26 weeks)
  • Incidence of surgical postoperative complications(From immediately after surgery until hospital discharge, up to 26 weeks)
  • Incidence of Intensive Care Unit admission and its duration(From immediately after surgery until hospital discharge, up to 26 weeks)
  • Incidence of length of in-hospital stay(From immediately after surgery until hospital discharge, up to 26 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elena Giovanna Bignami

Professor

University of Parma

研究点 (1)

Loading locations...

相似试验