Comparison of Endotracheal Tube Suctioning Versus No Suctioning During Emergence From General Anesthesia With Endotracheal Intubation: A Randomized, Single-Blind Study
概览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 408
- 试验地点
- 1
- 主要终点
- Incidence of postoperative desaturation after extubation
概览
简要总结
The goal of this study is to determine whether omitting tracheal suctioning immediately prior to extubation is non-inferior to routine tracheal suctioning with respect to early postoperative oxygenation among adult surgical patients (aged 18-90 years, American Society of Anesthesiologists [ASA] physical status I-III) undergoing elective surgery under general anesthesia with endotracheal intubation.
The study addresses the following questions:
- Primary outcome (non-inferiority):
- Is the risk of postoperative desaturation (oxygen saturation [SpO₂] <92% within 60 minutes after extubation) in the no-suction group not worse than in the routine-suction group by more than 10 percentage points?
- Secondary outcomes (superiority):
- Does omitting tracheal suctioning reduce postoperative cough severity and sore throat?
- Does omitting tracheal suctioning avoid increasing extubation-related adverse events?
Participants will be randomly assigned (1:1) to one of two groups:
- Routine suctioning (SUC): Endotracheal suctioning plus oropharyngeal suctioning immediately before extubation
- No suctioning (NON-SUC): Oropharyngeal suctioning only, without endotracheal suctioning
All participants will receive standard anesthetic care and postoperative monitoring in the post-anesthesia care unit (PACU) for 60 minutes. Follow-up for airway symptoms and patient satisfaction will be conducted at 24 hours after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
The anesthesiologist performing the intervention, the participants, and the investigators involved in intraoperative care and data collection were not masked because the suctioning procedures could not be concealed. The outcomes assessor, responsible for recording postoperative oxygen saturation, airway symptoms, and patient-reported outcomes, was blinded to the group assignment.
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
- •Adults aged 18-90 years with American Society of Anesthesiologists (ASA) physical status I-III.
- •Scheduled for elective surgery under general anesthesia requiring endotracheal intubation.
- •Planned tracheal extubation in the operating room at the end of surgery.
排除标准
- •Inability to provide informed consent or the presence of a significant language barrier that prevents effective communication with the clinical team.
- •Known diagnosis of obstructive sleep apnea (OSA), active pneumonia, or chronic pulmonary disease (e.g., chronic obstructive pulmonary disease, restrictive lung disease).
- •Body mass index (BMI) \>35 kg/m².
- •Pregnancy or increased aspiration risk (e.g., full stomach).
- •Scheduled for maxillofacial, head and neck, or airway surgery.
- •Anticipated surgical duration \>3.5 hours.
- •Anticipated difficult airway, defined as the presence of ≥2 predictors of difficult mask ventilation (DMV) based on Langeron et al., or a documented history of difficult intubation.
研究组 & 干预措施
Routine Endotracheal Suctioning (SUC)
Participants in this arm received routine endotracheal suctioning immediately prior to extubation, performed using standard suction pressure and technique. Oropharyngeal suctioning was also performed according to usual clinical practice.
干预措施: Routine Endotracheal Suctioning (Procedure)
Omission of Endotracheal Suctioning (NON-SUC)
Participants in this arm received oropharyngeal suctioning only prior to extubation. No suction catheter was inserted into the trachea. Standard anesthetic care and monitoring were provided as per routine practice.
干预措施: Omission of Endotracheal Suctioning (Procedure)
结局指标
主要结局
Incidence of postoperative desaturation after extubation
时间窗: First 60 minutes after extubation
Proportion of participants who develop desaturation, defined as peripheral oxygen saturation (SpO₂) \<92% at any time within the first 60 minutes after extubation.
次要结局
- Incidence and severity of postoperative coughing(First 60 minutes after extubation)
- Severity of sore throat during swallowing(First 60 minutes after extubation)
- Requirement and level of oxygen therapy(First 60 minutes after extubation)
- Incidence of postoperative nausea and vomiting(First 60 minutes after extubation)
- Patient satisfaction(At 24 hours after surgery (± 2 hours))
- Incidence of extubation-related adverse events(From arrival in the PACU until discharge from the PACU, assessed up to 6 hours after PACU arrival.)