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临床试验/NCT06770322
NCT06770322已完成不适用

Comparison of Conventional and Manometry Measurement Methods in the Evaluation of Perioperative Laryngeal Edema by USG in Patients Undergoing Lumbar Stabilization Surgery

Fatih Sultan Mehmet Training and Research Hospital2 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2025年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
65
试验地点
2
主要终点
Measurement of airway column width

研究概览

简要总结

In this study, the investigators aimed to evaluate perioperative laryngeal edema in patients undergoing lumbar stabilization surgery in the pron position, which the investigators use in our routine anesthesia practice, by using conventional and manometry measurement methods and ultrasonography, which the investigators also use frequently in our routine, and to evaluate complications related to laryngeal edema in postoperative service follow-up.

详细描述

Prone position is the position in which the patient is laid on his/her abdomen, arms are turned to the sides and the head is turned to one side. Prone position is one of the most commonly used positions in different surgical procedures. Lumbar spinal surgeries (lumbar stabilization, lumbar disc herniation, etc.) are some of the types of surgical operations performed in the pron position. While giving pron position, the table and necessary materials are prepared. A thin pillow is placed under the head and the head is turned to one side. The arms are extended to the side or placed under the head. The abdomen is freed by placing a small support at the hip and shoulder level. Make sure that the eyes are closed to avoid eye pressure. In patients with large breasts and abdomen, a thin pillow is placed under the chest. The feet are supported with a pillow under the ankles. With this position under anesthesia, diaphragmatic movements are restricted as the body weight is placed on the abdominal wall, and the increase in intra-abdominal pressure makes venous return difficult. The breasts in women and genital organs in men may remain under pressure. Weight on bony structures and fingers may cause pressure trauma. These effects can be eliminated with a pillow placed at the shoulder and pelvis level and free movement of the abdomen is provided.

Hemodynamic and position-related complications can often be observed in patients operated in the pron position.

Complications related to the position itself include loss of vision, conjunctival redness ischemic orbital compartment syndrome, nerve damage, abdominal compartment syndrome, acute glaucoma, diplopia, pneumocephalus, shoulder dislocation, endotracheal tube obstruction, facial edema, enteral nutrition intolerance, accidental extubation and small bowel obstruction may be observed. Hemodynamic complications include decreased venous return due to increased intra-abdominal pressure and consequently decreased stroke volume, increased sympathetic response, increased heart rate, increased systemic and pulmonary vascular resistance and decreased left ventricular compliance due to increased intrathoracic pressure. Laryngeal edema may be observed due to compression on the face, jaw and neck and also due to compression of the intubation tube cuff on the tracheal wall and may constitute a risk factor for the development of postextubation stridor after extubation. Laryngeal edema may cause sore throat, cough, dysphonia, dysphagia and even reintubation due to narrowed airway in the patient after extubation, which is seen in the definition of postextubation stridor.

One of the drawbacks of this position in patients to be given general anesthesia is the decrease in airway safety. There is a possibility of tube dislodgement, displacement and kinking during and after the patients are turned to pron position. Therefore, patients should be intubated with a spiral tube, the tube location should be verified and fixed, and the tube location should be verified again after turning to the pron position.

The ideal pressure of the cuff of the intubation tube is 25-30 cmH2O when measured with a cuff manometer. The conventional method, which has been the practice for years, i.e. inflating the intubation cuff with a syringe according to the clinician's own practice, may cause edema in the tracheal wall and larynx and even tracheal necrosis after a while if the cuff is inflated too much. It has been demonstrated that if the pressure of the intubation tube cuff exceeds 30 cm H2O, the blood flow in the tracheal mucosa starts to decrease and if it exceeds 50 cm H2O, ischemic damage develops.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
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

入选标准

  • Patients who will undergo lumbar spinal surgery under general anesthesia under elective conditions
  • Patients aged 18-65 years, included in the ASA I-III group
  • Patients whose consent has been obtained

排除标准

  • Patients under 18 years of age, over 65 years of age, included in the ASA IV-V group
  • Patients with a history of surgery in the oral cavity, including direct laryngoscopy and biopsy, microlaryngoscopic surgery, tonsillectomy, adenoidectomy, soft palate, oropharynx, hypopharynx, larynx and trachea,
  • Patients with a history of allergies, asthma, reflux, upper respiratory viral or fungal infections and cancer surgeries,
  • Patients receiving radiotherapy to the neck who had multiple intubation attempts in the previous year,
  • Patients undergoing emergency surgery,
  • Patients with advanced cardiac, renal, pulmonary and hepatic failure,
  • Patients who did not give consent to participate in the study.

结局指标

主要结局

Measurement of airway column width

时间窗: through study completion, an average of 6 months

Measurement of the effect of conventional and manometry methods on air column width by ultrasonography. With ultrasonography, laryngeal edema development can be observed in patients by measuring the air column width after intubation and before extubation in the transverse axis with a linear probe over the patient's cricothyroid membrane

次要结局

  • Detection of complications due to postoperative laryngeal edema(It will be evaluated at PACU 5th minute and postoperative 4, 8, 24th hours)

研究者

发起方
Fatih Sultan Mehmet Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mustafa Berkehan Nizamlıoğlu

resident doctor

Fatih Sultan Mehmet Training and Research Hospital

研究点 (2)

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