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Fiberoptic Bronchoscope of Double Lumen Tube and Single Lumen Tube in Patients With Semi-regid Neck Collar.

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ClinicalTrials.gov Identifier: NCT03392766
Recruitment Status : Recruiting
First Posted : January 8, 2018
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
DAE HEE KIM, Ajou University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Intubation;Difficult Thoracic Diseases Device: single lumen tube and bronchial blocker Device: double lumen tube Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: Comparison of Fiberoptic Intubation Between Double Lumen Tube and Single Lumen Tube in Patients With Semi-rigid Neck Collar Immobilization of the Cervical Spine.
Actual Study Start Date : February 9, 2018
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : December 30, 2018

Arm Intervention/treatment
Experimental: Single lumen tube and bronchial blocker
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 single lumen tube and bronchial blocker.

Experimental: Double lumen tube
neck collar apply. fibreoptic intubation with double lumen tube
Device: double lumen tube
neck collar apply. fibreoptic intubation with double lumen tube.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. insertion time [ 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

  2. railroading time [ 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.

  3. grade of ease of insertion over fibreoptic bronchoscope [ 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.

  4. trauma around the glottis [ Time Frame: through study completion, an average of 4 hour ]
    fibreoptic observation of the glottic bleeding.

  5. complication at the post-anesthesia care unit [ Time Frame: through study completion, an average of 4 hour ]
    hoarseness, sore throat, swallowing difficulty



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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03392766


Contacts
Contact: Dae Hee Kim, M.D. +82-10-3421-1022 anekim@ajou.ac.kr

Locations
Korea, Republic of
Ajou universiry hospital Recruiting
Suwon, Gyeonggi-do, Korea, Republic of
Contact: Dae Hee Kim, MD    +821034211022    anekim@ajou.ac.kr   
Sponsors and Collaborators
Ajou University School of Medicine
Investigators
Principal Investigator: Dae Hee Kim, M.D. Ajou unversity hospital

Responsible Party: DAE HEE KIM, Assistant Professor, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT03392766     History of Changes
Other Study ID Numbers: AJIRB-DEV-OBS-17-247
First Posted: January 8, 2018    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by DAE HEE KIM, Ajou University School of Medicine:
fibreoptic intubation
double lumen tube
difficult intubation

Additional relevant MeSH terms:
Thoracic Diseases
Respiratory Tract Diseases