Ajou universiry hospital
Suwon, Gyeonggi-do, South Korea
NCT Number: NCT03392766
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.
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Notify Me19 year–75 year
All sexes
Interventional
Not applicable
Suwon, Gyeonggi-do, South Korea
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
neck collar apply. fibreoptic intubation with single lumen tube and bronchial blocker.
neck collar apply. fibreoptic intubation with double lumen tube.
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.
Time frame: 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
Time frame: through study completion, an average of 4 hour
the time from fibreoptic bronchoscope positioning above the carina to tracheal tube positioning above the carina.
Time frame: 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.
Time frame: through study completion, an average of 4 hour
fibreoptic observation of the glottic bleeding.
Time frame: through study completion, an average of 4 hour
hoarseness, sore throat, swallowing difficulty
Ajou University School of Medicine
Other
Comparison of Fiberoptic Intubation Between Double Lumen Tube and Single Lumen Tube in Patients With Semi-rigid Neck Collar Immobilization of the Cervical Spine.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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