An interventional study of single lumen tube and bronchial blocker and double lumen tube in Intubation;Difficult and Thoracic Diseases, sponsored by Ajou University School of Medicine. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-04-23.
Sponsored by Ajou University School of Medicine · Not applicable, Interventional, and Other
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.
72 studies on the registry are indexed under Thoracic Diseases; 13 are open to participants now.
This study's enrollment of 80 is above the median of 65 across 52 interventional studies indexed under Thoracic Diseases.
Browse Thoracic Diseases studies →Ajou University School of Medicine is the lead sponsor of 173 studies on the registry; 16 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
neck collar apply. fibreoptic intubation with single lumen tube and brochial blocker
Device: single lumen tube and bronchial blocker
neck collar apply. fibreoptic intubation with double lumen tube
Device: double lumen tube
neck collar apply. fibreoptic intubation with single lumen tube and bronchial blocker.
neck collar apply. fibreoptic intubation with double lumen tube.
intubation time
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
insertion time
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
railroading time
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
grade of ease of insertion over fibreoptic bronchoscope
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
trauma around the glottis
fibreoptic observation of the glottic bleeding.
Time frame: through study completion, an average of 4 hour
complication at the post-anesthesia care unit
hoarseness, sore throat, swallowing difficulty
Time frame: through study completion, an average of 4 hour
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2018 to primary completion in Apr 2019, 14 months.
Of 27 interventional studies with no phase under Thoracic Diseases, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 42. This study's 14 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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