Intubation;Difficult, Thoracic Diseases
Conditions
Keywords
fibreoptic intubation, double lumen tube, difficult intubation
Brief summary
Many intrathoracic procedures demand optimal collapse of the operative lung to facilitate surgical exposure. Single-lung ventilation can be achieved using a double-lumen tube (DLT), a Univent tube, or an independent bronchial blocker. Insertion of a DLT using a direct laryngoscope can be more difficult than that of single-lumen tube (SLT), especially in patients for whom airway difficulty is anticipated. The safest of the proposed methods involves the placement of an SLT with the aid of an fibreoptic bronchoscope (FOB), following which the SLT is replaced with a DLT using an airway exchange technique in these patients. 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 with as much as ease as a standard SLT. In the present study, the investigators aimed to test the hypothesis that the HumanBroncho® DLT would be non-inferior to a standard SLT with regard to intubation time over an FOB in patients with semi-rigid neck collar simulating difficult airway.
Interventions
neck collar apply. fibreoptic intubation with single lumen tube and bronchial blocker.
DEVICEdouble lumen tube
neck collar apply. fibreoptic intubation with 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 requiring one lung ventilation. American Society of Anesthesiologist, Physical Status 1,2
Exclusion criteria
* abnormality of upper airway gastroesophageal disease risk of aspiration BMI \> 35
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| intubation time | through study completion, an average of 4 hour | the time from the passage of the fibreoptic bronchoscope beyond the teeth, to tracheal tube positioning above the carina. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| insertion time | through study completion, an average of 4 hour | the time from the passage of the fibreoptic bronchoscope beyond the teeth, to fibreoptic bronchoscope positioning above the carina |
| railroading time | through study completion, an average of 4 hour | the time from fibreoptic bronchoscope positioning above the carina to tracheal tube positioning above the carina. |
| grade of ease of insertion over fibreoptic bronchoscope | through study completion, an average of 4 hour | 1, no difficulty passing the tube; 2, obstruction while passing the tube, relieved by withdrawal and a 90° counter-clockwise rotation; 3, obstruction necessitating more than one manipulation or external laryngeal manipulation; 4, direct laryngoscopy was required. |
| trauma around the glottis | through study completion, an average of 4 hour | fibreoptic observation of the glottic bleeding. |
| complication at the post-anesthesia care unit | through study completion, an average of 4 hour | hoarseness, sore throat, swallowing difficulty |
Countries
South Korea
Outcome results
None listed