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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 Hospital1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2025年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
62
试验地点
1
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

Lumbar spine surgery is commonly performed in the prone position. Although the prone position provides optimal surgical exposure, it may be associated with several physiological and position-related complications. Increased intra-abdominal and intrathoracic pressures may affect venous return and hemodynamics, while compression of the face, neck, and upper airway may contribute to facial and laryngeal edema. In addition, displacement, obstruction, or kinking of the endotracheal tube may occur after positioning.

Endotracheal tube cuff pressure represents another potential contributor to airway morbidity. The recommended cuff pressure is generally 25-30 cmH₂O. Excessive cuff pressure may impair tracheal mucosal perfusion and contribute to mucosal injury and postoperative airway symptoms. In conventional clinical practice, cuff inflation is often performed by manual palpation of the pilot balloon, whereas cuff manometry allows objective measurement and adjustment of cuff pressure.

Ultrasonographic measurement of laryngeal air column width (ACW) provides a non-invasive method for assessing peri-extubation changes in the upper airway. In this study, ACW is measured after tracheal intubation and again before extubation, and the pre-extubation/post-intubation ACW ratio is used to assess perioperative changes suggestive of laryngeal edema.

This prospective observational study evaluates peri-extubation laryngeal edema in adult patients undergoing elective lumbar stabilization surgery in the prone position at Fatih Sultan Mehmet Training and Research Hospital. Participants are categorized according to the endotracheal tube cuff inflation technique used as part of routine anesthetic care: conventional pilot balloon palpation (Conventional group) or manometer-guided cuff inflation (Manometer group). No study-specific random allocation is performed, and the cuff inflation technique is determined as part of routine anesthetic practice rather than by the research protocol.

After standard monitoring and induction of general anesthesia, patients are intubated by direct laryngoscopy using an appropriately sized reinforced orotracheal tube. In the Conventional group, the endotracheal tube cuff is inflated manually according to the attending anesthesiologist's routine clinical practice, after which cuff pressure is measured using a cuff manometer and recorded. In the Manometer group, cuff pressure is adjusted to 25-30 cmH₂O using a cuff manometer. Thereafter, cuff pressure is measured and recorded at 30-minute intervals throughout the operation in both groups. In the Conventional group, cuff pressure is measured and recorded at these intervals without protocol-driven adjustment, whereas in the Manometer group, cuff pressure is readjusted to 25-30 cmH₂O when necessary.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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 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.

研究组 & 干预措施

Conventional

Other

The endotracheal tube cuff was manually inflated according to the attending anesthesiologist's routine clinical practice. The initial cuff pressure was subsequently measured using a cuff manometer and recorded. During surgery, cuff pressure was measured and recorded at 30-minute intervals without protocol-driven adjustment.

干预措施: Conventional (Procedure)

Manometer

Experimental

The endotracheal tube cuff pressure was initially adjusted to 25-30 cmH₂O using a cuff manometer. During surgery, cuff pressure was measured and recorded at 30-minute intervals and was readjusted to 25-30 cmH₂O when necessary. This cuff management approach was part of routine anesthetic care and was not assigned by the study protocol.

干预措施: manometer (Procedure)

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 (1)

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