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Completed

NCT Number: NCT03889847

Comparison of Fiberoptic Bronchoscopic Intubation Between Silicone and Polyvinylchloride Double Lumen Tube.

One lung ventilation (OLV) is required during thoracic procedure such as lung and esophagus surgery, and carried out by double lumen tube(DLT). Direct insertion of DLT over a fibreoptic bronchoscope (FOB) is considered more difficult and traumatic than that of a single-lumen tube. Recently, One recent simulation study demonstrated that a soft silicone DLT with a flexible, wire-reinforced bronchial tip (Fuji-Phycon tube) may shorten the time to intubation via tube exchange when compared with less compliant, polyvinyochloride(PVC) DLTs such as the Shilly or Rusch DLT. 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 easier than the Shilly tube.

In the present study, The investigators aimed to test the hypothesis that the silicone DLT would be easier than PVC DLT with regard to railroading grade over an FOB. Investigators further aimed to compare the intubation time over the FOB between the silicone DLT and PVC DLT.

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Key information

Conditions

Intubation;Difficult

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ajou universiry hospital

Suwon, Gyeonggi-do, 16499, 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 and one lung ventilation American Society of Anesthesiologist physical status 1,2

Exclusion criteria

  • abnormal upper airway, gastrointestinal disease, risk of aspiration, BMI > 35

Treatment and study plan

Fibreoptic intubation with silicone double lumen tube

Device

Fibreoptic intubation with silicone double lumen tube

Fibreoptic intubation with PVC double lumen tube

Device

Fibreoptic intubation with PVC double lumen tube

Primary outcomes

  1. railroading grade

    Time frame: an average of 2 minutes

    grade of ease of railroading over fibreoptic bronchoscope.

    • no difficulty passing the tube
    • obstruction while passing the tube, relieved by withdrawal and 90 degree counter-clockwise rotation(2-1) or more than 90 degree rotation(2-2)
    • obstruction necessitating more than one manipulation or external laryngeal manipulation
    • direct laryngoscope was required

Secondary outcomes

  1. insertion time

    Time frame: an average of 2 minutes

    time from insertion of FOB into mouth to tube placement into trachea and left main bronchus

  2. number of patients with trauma around glottis, observed by FOB

    Time frame: an average of 2minutes

    glottic trauma observation through FOB outside the tube

  3. number of patients with tube repositioning during the surgery

    Time frame: an average of 3.5 hours

    count of tube repositioning with FOB during the surgery

  4. number of patients with complication of hoarseness, sore throat, and swallowing difficulty

    Time frame: an average of 30 minutes

    hoarseness, sore throat, swallowing difficulty in post-anesthesia care unit

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 26, 2019
Registry last updated
Jan 20, 2021

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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