Association Between Preoperative Oronasal Breathing Patterns and Endotracheal Tube Intolerance During Emergence From General Anesthesia: A Prospective Nested Case-Control Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 224
- 主要终点
- Endotracheal Tube Intolerance
研究概览
简要总结
This is a case-control study designed to enroll 224 patients who will undergo tracheal intubation for general anesthesia in the operating rooms of Peking University People's Hospital between July 20, 2026, and October 31, 2026. The case group will consist of patients who develop coughing before extubation (N=112), while the control group will comprise those without coughing before extubation (N=112).
Data to be collected include general demographic characteristics, smoking and smoking cessation history, comorbid conditions (with particular attention to snoring during sleep and sleep apnea-hypopnea syndrome [SAHS]), history of pulmonary diseases, mode of spontaneous breathing, surgical and anesthetic data, as well as blood pressure and heart rate before, during, and after extubation, pain scores, and sedation levels.
Continuous variables will be presented as mean ± standard deviation (for normally distributed data) or median with interquartile range (IQR) (for non-normally distributed data). Categorical variables will be described using frequencies and percentages (e.g., sex, smoking history). Baseline differences between the case and control groups will be compared using the chi-square test (for categorical variables), Student's t-test (for normally distributed continuous variables), or the Mann-Whitney U test (for non-normally distributed continuous variables). Multivariable logistic regression analysis will be employed to evaluate the independent association between the mode of spontaneous breathing and coughing before extubation, with adjustment for potential confounding factors, and odds ratios (ORs) with their 95% confidence intervals (95%CI) will be calculated. All statistical analyses will be performed using SPSS or R software.
详细描述
Eligible patients will be enrolled for observation. Based on whether coughing occurs before extubation after emergence from anesthesia, patients will be divided into a case group (those who develop coughing) and a control group (those who do not).
Non-invasive cuff blood pressure readings will be recorded before, during, and after extubation. Post-extubation pain scores and sedation levels (assessed using the Ramsay Sedation Scale) will also be documented.
General demographic characteristics, smoking and smoking cessation history, presence of snoring during sleep, comorbid conditions (with particular emphasis on sleep apnea-hypopnea syndrome), history of pulmonary diseases, mode of spontaneous breathing, and surgical and anesthetic data will be collected.
Primary outcome: occurrence of coughing before extubation after emergence from anesthesia.
Definition of coughing: Coughing is defined as the occurrence of cough in a patient who has emerged from anesthesia after administration of reversal agents at the end of surgery, while the tracheal tube is still in place and connected to the ventilator in manual ventilation mode (with the adjustable pressure limiting [APL] valve set at 0 cmH₂O), and when extubation criteria have been met but the tube has not yet been removed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing general anesthesia with endotracheal intubation;
- •Written informed consent obtained.
排除标准
- •Patients with severe psychiatric disorders;
- •Deaf or mute patients who are unable to answer questions;
- •Patients who develop postoperative cognitive dysfunction and are consequently unable to answer questions;
- •Patients who withdraw from the study prematurely;
- •Patients who are extubated after being transferred to the recovery room or intensive care unit (i.e., extubation not performed in the operating room).
研究组 & 干预措施
Mouth Breathing
The patients' breathing pattern is predominantly oral.
Nasal Breathing
The patients' breathing pattern is predominantly nasal.
结局指标
主要结局
Endotracheal Tube Intolerance
时间窗: Pre-extubation period
Definition of Bucking / Emergence Coughing: Bucking is defined as a reflexive cough occurring during the emergence phase following the administration of reversal agents at the conclusion of surgery. It manifests while the patient is mechanically ventilated in the manual ventilation mode via the endotracheal tube (with the adjustable pressure-limiting \[APL\] valve set at 0 cmH₂O), after extubation criteria have been met but prior to the actual removal of the tracheal tube. Severity Grading of Bucking (Clinical Scale): Grade 0: No bucking. Grade 1: Isolated, single cough. Grade 2: Intermittent coughing (more than one episode, non-sustained). Grade 3: Sustained, repetitive coughing accompanied by head lifting (indicating severe emergence agitation/reflex).
次要结局
未报告次要终点
研究者
Yi Feng, MD
Chief of Anesthesiology
Peking University People's Hospital
