Intubation;Difficult
Conditions
Keywords
Fiberoptic intubation, double lumen tube
Brief summary
One lung ventilation (OLV) is required during thoracic procedure such as lung and esophagus surgery, and carried out by double lumen tube(DLT). Direct insertion of DLT over a fibreoptic bronchoscope (FOB) is considered more difficult and traumatic than that of a single-lumen tube. Recently, One recent simulation study demonstrated that a soft silicone DLT with a flexible, wire-reinforced bronchial tip (Fuji-Phycon tube) may shorten the time to intubation via tube exchange when compared with less compliant, polyvinyochloride(PVC) DLTs such as the Shilly or Rusch DLT. HumanBroncho® (Insung Medical, Seoul, Korea) is a new silicone DLT with a soft, flexible, non-bevelled, wire-reinforced tip. The oval shape, obtuse angle, and short lateral internal diameter of the bronchial lumen and its flexibility may allow for advancement to the trachea over the FOB easier than the Shilly tube. In the present study, The investigators aimed to test the hypothesis that the silicone DLT would be easier than PVC DLT with regard to railroading grade over an FOB. Investigators further aimed to compare the intubation time over the FOB between the silicone DLT and PVC DLT.
Interventions
DEVICEFibreoptic intubation with silicone double lumen tube
Fibreoptic intubation with silicone double lumen tube
DEVICEFibreoptic intubation with PVC double lumen tube
Fibreoptic intubation with PVC double lumen tube
Sponsors
Ajou University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* patients undergoing thoracic surgery and one lung ventilation American Society of Anesthesiologist physical status 1,2
Exclusion criteria
* abnormal upper airway, gastrointestinal disease, risk of aspiration, BMI \> 35
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| railroading grade | an average of 2 minutes | grade of ease of railroading over fibreoptic bronchoscope. 1. no difficulty passing the tube 2. obstruction while passing the tube, relieved by withdrawal and 90 degree counter-clockwise rotation(2-1) or more than 90 degree rotation(2-2) 3. obstruction necessitating more than one manipulation or external laryngeal manipulation 4. direct laryngoscope was required |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| insertion time | an average of 2 minutes | time from insertion of FOB into mouth to tube placement into trachea and left main bronchus |
| number of patients with trauma around glottis, observed by FOB | an average of 2minutes | glottic trauma observation through FOB outside the tube |
| number of patients with tube repositioning during the surgery | an average of 3.5 hours | count of tube repositioning with FOB during the surgery |
| number of patients with complication of hoarseness, sore throat, and swallowing difficulty | an average of 30 minutes | hoarseness, sore throat, swallowing difficulty in post-anesthesia care unit |
Countries
South Korea
Outcome results
None listed