The Efficacy of Trachway (R) Intubating Stylet in the Insertion of the Double Lumen Endobronchial Tube

The Comparison of Direct Laryngoscope and Trachway (R) Intubating Stylet in the Insertion of the Double Lumen Endobronchial Tube

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01517204

Enrollment

Registered

2012-01-25

Start date

2011-05-31

Completion date

2012-05-31

Last updated

2012-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia Intubation Complications

Keywords

Trachway(R) intubating stylet, Left sided double lumen endobronchial tube, Efficacy, Intubation complication

Brief summary

The purpose of this study is to investigate the effects of Trachway(R) compared with direct laryngoscope in tracheal intubation of double-lumen endobronchial tube.

Detailed description

Intubation with the double-lumen endobronchial tube (DLT) remains a great challenge for anesthesiologists. Although new upper airway devices, such as Trachway (R), a video-assisted intubating stylet, had been developed for facilitating airway management. The larger size and the complexity of DLT than single-lumen tube (SLT) makes the difficulties for DLT intubation. Therefore, the investigators designed this study to investigate the effects of Trachway(R)compared with direct laryngoscope in DLT intubation.

Interventions

DEVICEDirect laryngoscope (Macintoish laryngoscope)

Direct laryngoscope was used to facilitate the intubation of left-sided DLT.

DEVICETrachway(R) intubating stylet

Trachway(R) intubating stylet was used to facilitate the intubation of left-sided DLT.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. patients with American Society of Anesthesiologists physical status I-III 2. More than 18 years of age 3. Requiring DLT for thoracic surgery

Exclusion criteria

1. risk of regurgitation and pulmonary aspiration 2. history of gastroesophageal reflux, pregnancy 3. scheduled tracheostomy and postoperative prolonged ventilation in ICU 4. patients with limited neck extension (\< 35°) 5. a distance between the tip of the patient's mandible and hyoid bone of less than 7 cm 6. a sternomental distance of less than 12.5 cm with the head fully extended 7. mouth can not open

Design outcomes

Primary

Measure	Time frame
Main outcome measure is the successful rate of the first intubation	12 month

Secondary

Measure	Time frame	Description
The outcome measure is mean blood pressure (MAP) during intubation period	12 months	MAP was measured before intubation, and after intubation 1, 3,and 5 min.
The outcome measure is the heart rate (HR) during intubation period	12 months	HR was measured and recorded before intubation, and after intubation 1, 3,and 5 min.
The outcome measure is the time needed to insert the DLT	12 months	—
The outcome measure is the incidence of sore throat.	12 months	Sore throat was observed and evaluated after extubation and patient regained consciousness.
The outcome measure is the incidence of hoarseness.	12 months	Hoarseness was observed and evaluated after extubation and patient regained consciousness.
The outcome measure is the incidence of hypoxemia.	12 months	Hypoxemia was defined as SPO2 less than 90%. Hypoxemia was recorded during the period of intubation.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026