Effect of the Use of Endotracheal Tube With Subglottic Suction on Laryngospasm and Postoperative Complications in Rhinoplasty Operations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Incidence of laryngospasm
研究概览
简要总结
Suction Above Cuff Endotracheal Tube (SACETT) has a dorsal port above the cuff designed to allow continuous or intermittent suctioning of secretions from the subglottic space. Thus, it facilitates suctioning of excessive secretions around the mouth and the cuff. In this study, we aimed to investigate the effect of the use of SACETT on laryngospasm and postoperative complications in rhinoplasty operations. This randomized controlled clinical trial was conducted in 132 patients undergoing rhinoplasty.
The investigators believe that the use of SACETT in rhinoplasty operations reduces the incidences of laryngospasm, emergence agitation, sore throat, swallowing difficulty, and PONV when compared with classic endotracheal tube.
详细描述
Suction Above Cuff Endotracheal Tube (SACETT) has a dorsal port above the cuff designed to allow continuous or intermittent suctioning of secretions from the subglottic space. Thus, it facilitates suctioning of excessive secretions around the mouth and the cuff. In this study, the investigators aimed to investigate the effect of the use of SACETT on laryngospasm and postoperative complications in rhinoplasty operations.
This randomized controlled clinical trial was conducted in 132 patients undergoing rhinoplasty. The patients were randomly divided into 2 groups: Suction Above Cuff Endotracheal Tube (n:66) (Group SA) and classic endotracheal tube (n:66) (Group C). Complications following general anesthesia were statistically analyzed among the two groups.
55 male patients and 77 female patients were included in the study. The incidences of postoperative laryngospasm and respiratory complications were found to be lower in Group SA compared to Group C. In addition, the incidences of agitation, postoperative nausea and vomiting (PONV), swallowing difficulty, and sore throat were found to be lower in Group SA compared to Group C. However, the incidences of cough, hypotension, and tachycardia were similar in both groups. No PONV, swallowing difficulty, and hypotension were observed in Group SA. The blood volume accumulated in the suction chamber was found to be greater in Group SA compared to Group C.
The investigators believe that the use of SACETT in rhinoplasty operations reduces the incidences of laryngospasm, emergence agitation, sore throat, swallowing difficulty, and PONV when compared with classic endotracheal tube.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who will undergo rhinoplasty surgery,
- •American Society of Anesthesiologists (ASA) I-II patients,
- •Aged 18-65 years
排除标准
- •Patients who had upper or lower respiratory tract infections,
- •a history of allergy,
- •who received isoflurane and desflurane for maintenance of anesthesia,
- •who were the ASA class III-IV,
- •and who had a long uvula,
- •gastroesophageal reflux or sleep apnea,
- •electrolyte disturbances such as hypomagnesemia and hypocalcemia,
- •a BMI (body mass index) over 30 were excluded from the study.
研究组 & 干预措施
Group SA
Group SA intubated with Suction Above Cuff Endotracheal Tube
干预措施: Suction Above Cuff Endotracheal Tube (Other)
Group C
Group C intubated with classic endotracheal tube
结局指标
主要结局
Incidence of laryngospasm
时间窗: 1 mounth
While the presence of findings such as apnea (an apneic event was counted by either documentation of apnea by nursing notes through visual observation or documented pauses ≥15 s), desaturation (peripheral oxygen saturation \<85%) and inspiratory stridor (Stridor is a harsh, vibratory sound of variable pitch caused by partial obstruction of the respiratory passages that results in turbulent airflow through the airway) after extubation was considered as laryngospasm.
次要结局
- emergence agitation(1 mounth)
研究者
Nureddin YUZKAT
Assistant professor
Yuzuncu Yıl University