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临床试验/NCT07275502
NCT07275502进行中(未招募)不适用

Prospective Development and Validation of an Objective Classification for Difficult Facemask Ventilation: the MASCAN Score - Secondary Analysis of the Prospective Observational MASCAN Study

Universitätsklinikum Hamburg-Eppendorf1 个研究点 分布在 1 个国家目标入组 423 人开始时间: 2022年11月7日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
423
试验地点
1
主要终点
Difficult facemask ventilation

研究概览

简要总结

Difficult facemask ventilation remains poorly classified. Existing definitions rely on expert opinion and subjective rating of surrogates. This lack of standardization has led to highly variable reported incidences and inconsistencies in clinical practice and research.

This secondary analysis of the prospective observational MASCAN study aims to develop and validate a data-driven objective classification system for difficult facemask ventilation and to determine its diagnostic performance and calibration. Facemask ventilation was facilitated after anaesthesia induction in all patients. An independent observer systematically assessed potential indicators for difficult facemask ventilation that serve as candidate predictor variables for the fitting of a diagnostic multivariable logistic regression model and simplified score to classify difficult facemask ventilation. Cross-validated LASSO regression will be used for variable selection. The area under the receiver operating characteristic curve (AUROC) and calibration curves will be used to quantify the diagnostic performance and calibration, and optimal decision thresholds will be defined.

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

入选标准

  • Patients scheduling for ENT or OMS surgery in general anaesthesia, who require facemask ventilation and tracheal intubation after induction of anesthesia
  • Patients aged at least 18 years
  • Ability to understand the patient information and to personally sign and date the informed consent to participate in the study
  • The patient is co-operative and available for the entire study
  • Provided informed consent/patient representative

排除标准

  • Pregnant or breastfeeding woman
  • Rapid sequence induction or other contraindications for facemask ventilation
  • Planned awake tracheal intubation

结局指标

主要结局

Difficult facemask ventilation

时间窗: 1 hour

Alert documented in patients' health records by the airway operator following facemask ventilation (y/n)

次要结局

  • Impossible facemask ventilation(1 hour)
  • Airway-related adverse events(1 hour)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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