Clinical trial NCT02364622: The Effects of Flexible Intubating Stylet in the Accurate Placement of Double-lumen Endobronchial Tube
Official title: The Effects of Flexible Trachway(R) Intubating Stylet in the Accurate Placement of Left-sided Double-lumen Endobronchial Tube
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation Complication
Intubation, Difficult
Keywords: flexible intubating stylet
double-lumen endobronchial tube
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2015-02-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Main outcome measure is the successful rate of the first accurate placement of left-sided DLT in the trachea
timeFrame: 12 month
Secondary outcomes:
measure: The outcome measure is the time needed to accurate placement of left-sided DLT in the trachea
timeFrame: 12 month
measure: The outcome measure is mean blood pressure (MAP) during intubation period
timeFrame: 12 month
measure: The outcome measure is the heart rate (HR) during intubation period
timeFrame: 12 month
measure: The outcome measure is the incidence of hypoxemia
timeFrame: 12 month
measure: The outcome measure is the incidence of sore throat
timeFrame: 12 month
measure: The outcome measure is the incidence of hoarseness
timeFrame: 12 month
Other outcomes:
Locations:
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Medical University chung-Ho Memorial Hospital
Study officials:
affiliation: Department of Anesthesia, Kaohsiung Medical University Chung-Ho Memorial Hospital
name: Hung-Te Hsu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hsu HT, Kuo YW, Ma CW, Su MP, Tseng KY, Li CL, Cheng KI. Trachway(R) flexible stylet facilitates the correct placement of double-lumen endobronchial tube: a prospective, randomized study. BMC Anesthesiol. 2022 Aug 15;22(1):260. doi: 10.1186/s12871-022-01800-8.