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Completed

NCT Number: NCT03392766

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

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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Key information

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ajou universiry hospital

Suwon, Gyeonggi-do, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

single lumen tube and bronchial blocker

Device

neck collar apply. fibreoptic intubation with single lumen tube and bronchial blocker.

Double lumen tube

Device

neck collar apply. fibreoptic intubation with double lumen tube.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Registry information

Official study 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.

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 8, 2018
Registry last updated
Apr 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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