Comparison Between Diagnostic Performances of Auscultation and Ultrasonography Respect of Fiberoptic Bronchoscopy in the Valuation of Positioning of Endotracheal Double-lumen Tube in Elective Thoracic Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- To compare trans- thoracic ultrasound method and auscultation in left selective intubation with LDLT, considering them as an alternative to fiberoptic bronchoscope use.
研究概览
简要总结
The study will be to demonstrate that, in patients undergoing elective thoracic surgery, lung ultrasound (LUS) in OR is more sensitive, specific and accurate method than thoracic auscultation, for the evaluation of OLV. The aim of the study is to demonstrate how lung ultrasound can be considered an attractive alternative to the routine use of fiberbronchoscope as a first line diagnostic tool to verify the correct position of left double lumen tube.
详细描述
Most procedures in thoracic surgery require exclusion from ventilation of the lung undergoing surgery. One-lung ventilation (OLV), it is obtained mainly through the placement of a bi-lumen tube (DLT) in the patient's airway. A frequent complication that occurs during OLV it's unrecognized bad positioning of the DLT which can lead to serious complications such as hypoventilation, hypoxemia, not optimal collapse of the operated lung and damage to the trachea or main bronchi.
The latest SIAARTI recommendations (2009) advocate in all patients use of fiberbronchoscope (FOB) to control and correct the positioning of the DLT (gold standard) after the orotracheal intubation and after the positioning in lateral decubitus. The usual clinical practice expects to performing lung exclusion tests by auscultation of the 2 hemithorax in succession. But the scientific evidence shows how this practice has a poor sensitivity and specificity in assessing the correct positioning of the left DLT (LDLT). From literature, as from everyday clinical experience, it is known that FBS cannot always be performed Finally, the research wants to shed light how the fiberoptic bronchoscopy (FBS) is an invasive maneuver that is not free from serious complications (mucosal lesions and infections).
Ultrasound (US) over the last 15 years has made an important contribution to the assessment and management of the airways. US quickly and effectively are able to show the excursion of the diaphragm and pleura, qualitative and quantitative indicators of lung expansion. If the endotracheal tube is in the correct position, a bilateral and symmetrical movement of the domes of each hemi-diaphragm (B-Mode and M-mode) can be appreciated, while in the intercostal window, the so-called "lung-sliding" will be visible. In the absence of ventilation, the diaphragmatic excursion and the "lung-sliding" will not be detectable in the explored hemi-thorax.
Although FBS remains the gold standard for controlling the correct position of LDLT under thoracic anesthesia, and is often crucial as a guide to its repositioning, from the researchers point of view, the use of FOB may not be routinely necessary in all patients, but its use could be reserved for selected cases in which the positioning itself is difficult or in case of intraoperative displacement. Primary objective is to demonstrate how, in patients undergoing elective thoracic surgery, lung ultrasound (LUS) to the operating room is a more sensitive, specific and accurate method than thoracic auscultation, for the evaluation of OLV. LUS is a non-invasive, safe and free from side effects technique that can be performed at the patient's bed. The study aims to demonstrate how LUS can be considered an attractive alternative to the routine use of FOB as a first line diagnostic tool to verify the correct position of LDLT.
For each surgical procedure 3 researchers will participate, each with a specific independent role: the auscultation researcher (AR), which will have the task of performing the oral-tracheal intubation and auscultation with phonendoscope pre-and post-induction of general anesthesia and after positioning the patient in lateral decubitus; the ultrasound researcher (UR), i.e. the anesthesiologist who will perform the pre- and post-induction of the AG ultrasound evaluation and after positioning the patient in lateral decubitus; the Fiberscope Researcher (FR), whom will perform the fibrobroncoscopic verification of the LDLT at the end of the clinical and ultrasound assessment and after the positioning in lateral position. He will reposition the endotracheal tube in case of mal positioning or intra-operative displacement of the same.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Signed informed consent
- •Age > 18 years
- •Patients who underwent elective thoracic surgery (video-assisted thoracic surgery or open thoracotomy) requiring lung isolation and endotracheally intubation by LDLT
排除标准
- •Not signed informed consent
- •Age < 18 years
- •Previous history of thoracic surgery
- •Planned use of right double lumen tube
- •Pleural diseases: pleural spill, pneumothorax, mesothelioma, previous pleurodesis
- •Neuromuscular disease with proved diaphragmatic disfunction
- •Thoracic subcutaneous emphysema
- •Difficult endotracheally intubation or more than 3 attempts made by an experienced anesthesiologist or alternative device use
- •Pregnancy
- •Emergency surgery
结局指标
主要结局
To compare trans- thoracic ultrasound method and auscultation in left selective intubation with LDLT, considering them as an alternative to fiberoptic bronchoscope use.
时间窗: Through study completion, an average of 1 years
Sensitivity, specificity and accuracy of ultrasound method and auscultation method as technique to verify LDLT correct placement, checked with fiberoptic bronchoscope.
次要结局
- Presence/absence of lung sliding throw ultrasound scan in case of correct/incorrect position of LDLT(Through study completion, an average of 1 years)
- Incidence of intra- and post-operating complications(Through study completion, an average of 1 years)
- Measure of diaphragmatic displacement throw ultrasound scan in spontaneous breath and in mechanical ventilation(Through study completion, an average of 1 years)
- Evaluation time to perform lung ultrasound scansion during lung exclusion test(Through study completion, an average of 1 years)
- Incidence of LDLT malpositioning(Through study completion, an average of 1 years)
- Incidence of LDLT displacements after lateral positioning and during surgery(Through study completion, an average of 1 years)
- Presence/absence of lung pulse throw ultrasound scan in case of correct/incorrect position of LDLT(Through study completion, an average of 1 years)
- Evaluation time to perform auscultation during lung exclusion test.(Through study completion, an average of 1 years)
- Evaluation time to verifing of position of LDLT with FOB(Through study completion, an average of 1 years)
- Incidence of ICU admission (planned or unplanned)(Through study completion, an average of 1 years)
- ICU and Hospital length of stay(Through study completion, an average of 1 years)
- Incidence of mortality(Through study completion, an average of 1 years)
研究者
Elena Giovanna Bignami
Professor of Anesthesiology
University of Parma