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临床试验/NCT05224895
NCT05224895Unknown不适用

Evaluation of the Effect of Trendelenburg Position on the Ultrasonographic Airway Measurements and Critical Respiratory Events

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2022年2月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
70
试验地点
1
主要终点
postoperative Tongue thickness2

研究概览

简要总结

The aim of this study is to compare the changes in upper airway edema with the preoperative and postoperative ultrasonographic measurements of patients who undergo pobotic prostatectomy in the trendelenburg position.

The secondary aim is to investigate the correlation between OSAS risk levels determined by the STOP-BANG score in the preoperative period of the patients participating in the study airway ultrasound measurements and postoperative critical respiratory events in the preoperative and postoperative period.

详细描述

In the preoperative period, age, body weight, height, neck circumference, comorbidities (Charlson comorbidity index), ASA score, Modified mallampati classification, STOP-BANG risk score will be recorded.Intraoperative monitorization data will be recorded.

Following ultrasonographic airway measurements will be performed preoperatively and postoperatively.

A low frequency convex probe will be used for ultrasonography. To achieve a fixed position of the tongue, patients will be placed supine without a pillow, with their head fully tilted back, and asked to hold their tongue loosely, without phonation, with their mouth closed and tongue tips lightly touching the incisors. The probe will be placed under the chin in the median sagittal plane and adjusted to obtain a clear median sagittal tongue view.

Tongue thickness: When the ultrasound probe is placed under the chin on the median sagittal plane, with the mouth closed in the supine position, the tongue is in a natural position and the patient is silent, and the tongue root is displayed on the screen, the maximal vertical diameter from the tongue surface to the submental skin will be measured and recorded as tongue thickness .

Median sagittal tongue cross-sectional area: The sagittal cross-sectional area of the tongue will then be measured by tracing the circumference of the tongue on the ultrasound machine.

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 75 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Robotic Laparoscopic Prostatectomy
  • ASA I-II-III-IV risk group -

排除标准

  • contraindication of trendelenburg position,
  • history of maxillofacial deformity, tumor or trauma,
  • history of difficult airway,
  • decompensated cardiac, respiratory, hepatic, renal disease,
  • with cervical spine fracture
  • patient refusal -

结局指标

主要结局

postoperative Tongue thickness2

时间窗: postoperative 2. hour

When the ultrasound probe is placed under the chin on the median sagittal plane, with the mouth closed in the supine position, the tongue is in a natural position and the patient is silent, and the tongue root is displayed on the screen, the maximal vertical diameter from the tongue surface to the submental skin will be measured and recorded as tongue thickness

Preoperative Lateral parapharyngeal wall thickness

时间窗: Baseline, preoperative

The distance between the arteria carotid interna and the echogenic surface of the pharynx and the distance between the skin and the lateral wall of the pharynx will be measured

postoperative Lateral parapharyngeal wall thickness1

时间窗: immediately postextubation

The distance between the arteria carotid interna and the echogenic surface of the pharynx and the distance between the skin and the lateral wall of the pharynx will be measured

postoperative Lateral parapharyngeal wall thickness2

时间窗: postoperative 2. hour

The distance between the arteria carotid interna and the echogenic surface of the pharynx and the distance between the skin and the lateral wall of the pharynx will be measured

preoperative Tongue volume

时间窗: Baseline, preoperative

Tongue volume will then be obtained by multiplying the mid-sagittal tongue cross-sectional area by the tongue width

postoperativeTongue volume2

时间窗: postoperative 2. hour

Tongue volume will then be obtained by multiplying the mid-sagittal tongue cross-sectional area by the tongue width

postoperative Tongue thickness1

时间窗: immediately postextubation

When the ultrasound probe is placed under the chin on the median sagittal plane, with the mouth closed in the supine position, the tongue is in a natural position and the patient is silent, and the tongue root is displayed on the screen, the maximal vertical diameter from the tongue surface to the submental skin will be measured and recorded as tongue thickness

postoperative Tongue volume1

时间窗: immediately postextubation

Tongue volume will then be obtained by multiplying the mid-sagittal tongue cross-sectional area by the tongue width

Preoperative Tongue thickness

时间窗: Baseline, preoperative

When the ultrasound probe is placed under the chin on the median sagittal plane, with the mouth closed in the supine position, the tongue is in a natural position and the patient is silent, and the tongue root is displayed on the screen, the maximal vertical diameter from the tongue surface to the submental skin will be measured and recorded as tongue thickness

Number of participants with Critical respiratory events

时间窗: Within postoperative 2 hours

A PACU critical respiratory event (CRE), any unexpected hypoxemia (hemoglobin oxygen saturation \< 90%), hypoventilation (respiratory rate \< 8 bpm or arterial carbon dioxide tension \> 50 mmHg), or upper airway obstruction (stridor or laryngospasm) will be considered as requiring active and specific intervention (ventilation, tracheal intubation, opioid or muscle relaxant antagonism, oral/nasal airway or airway manipulation).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

ismail aytaç

principal investigator

Ankara City Hospital Bilkent

研究点 (1)

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