Comparison of Fiberoptic Intubation Between Double Lumen Tube and Single Lumen Tube in Patients With Semi-rigid Neck Collar Immobilization of the Cervical Spine.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- intubation time
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Single lumen tube and bronchial blocker
neck collar apply. fibreoptic intubation with single lumen tube and brochial blocker
Intervention: single lumen tube and bronchial blocker (Device)
Double lumen tube
neck collar apply. fibreoptic intubation with double lumen tube
Intervention: double lumen tube (Device)
Outcomes
Primary Outcomes
intubation time
Time Frame: 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 Outcomes
- grade of ease of insertion over fibreoptic bronchoscope(through study completion, an average of 4 hour)
- complication at the post-anesthesia care unit(through study completion, an average of 4 hour)
- railroading time(through study completion, an average of 4 hour)
- insertion time(through study completion, an average of 4 hour)
- trauma around the glottis(through study completion, an average of 4 hour)
Investigators
DAE HEE KIM
Assistant Professor
Ajou University School of Medicine