Intubation Complication, Intubation, Difficult
Conditions
Keywords
flexible intubating stylet, double-lumen endobronchial tube
Brief summary
The purpose of this study is to determine whether using the flexible Trachway(R) intubating stylet could facilitate and promote the accurate placement of double-lumen endobronchial tube.
Detailed description
How to accurately place the left-sided double-lumen endobronchial tube (DLT) in the trachea remains a great challenge for anesthesiologists. Although new upper airway devices, such as flexible Trachway (R), a video-assisted intubating stylet, had been developed for facilitating airway management, the larger size and the complexity of DLT makes the difficulties for accurate placement of DLT blindly. Therefore, the investigators designed this study to investigate the effects of flexibleTrachway(R) intubating stylet in the placement of left-sided DLT in the trachea.
Interventions
DEVICETranditional fiberoptic bronchoscopy
The accurate placement of left-sided DLT into the left main bronchus was facilitated by tranditional fiberoptic bronchoscopy.
DEVICEModified fiberoptic bronchoscopy
The accurate placement of left-sided DLT into the left main bronchus was facilitated by modified fiberoptic bronchoscopy
DEVICEFlexible Trachway intubating stylet
The accurate placement of left-sided DLT into the left main bronchus was faciliated by using flexible Trachway intubating stylet.
Sponsors
Kaohsiung Medical University Chung-Ho Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* patients with American Society of Anesthesiologists physical status I-III * More than 18 years of age * Requiring DLT for thoracic surgery
Exclusion criteria
* risk of regurgitation and pulmonary aspiration * history of gastroesophageal reflux, pregnancy * scheduled tracheostomy and postoperative prolonged ventilation in ICU * patients with limited neck extension (\< 35°) * a distance between the tip of the patient's mandible and hyoid bone of less than 7 cm * a sternomental distance of less than 12.5 cm with the head fully extended * mouth can not open
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main outcome measure is the successful rate of the first accurate placement of left-sided DLT in the trachea | 12 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The outcome measure is mean blood pressure (MAP) during intubation period | 12 month | MAP was measured before intubation, and after intubation 1, 3,and 5 min. |
| The outcome measure is the time needed to accurate placement of left-sided DLT in the trachea | 12 month | — |
| The outcome measure is the heart rate (HR) during intubation period | 12 month | HR was measured and recorded before intubation, and after intubation 1, 3,and 5 min |
| The outcome measure is the incidence of sore throat | 12 month | Sore throat was observed and evaluated after extubation and patient regained consciousness |
| The outcome measure is the incidence of hoarseness | 12 month | Hoarseness was observed and evaluated after extubation and patient regained consciousness |
| The outcome measure is the incidence of hypoxemia | 12 month | Hypoxemia was defined as SPO2 less than 90%. Hypoxemia was recorded during the intubation period. |
Countries
Taiwan
Outcome results
None listed