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Completed

NCT Number: NCT02190032

Modified Angled Tube vs. Conventional Angled Tube in Double-lumen Endotracheal Tube Intubation

The investigators are trying to compare the individually modified-angled tube and the conventional-angled tube in ease of double lumen endotracheal tube insertion and the incidence of related postoperative complications.

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Key information

Conditions

Intubation, Intratracheal Thoracic Surgical Procedures

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

About this study

Inserting a double lumen endotracheal tube is somewhat more difficult than a single lumen tube intubation because of its larger outer diameter and the more rigid feature. Moreover, the airway axes (oral-,pharyngeal-, and laryngotracheal axis) are not always straight under sniffing condition. Therefore, to make easy to insert a double-lumen tube and reduce the tube-related complications, we are trying to compare the individually angle-modified tube and the manufacturer-provided-angled tube.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects undergoing thoracic surgery under one lung ventilation
  • Subjects older than 20 yrs who can give written informed consent

Exclusion criteria

  • Those who need rapid sequence intubation
  • Those with cervical spinal disease (cervical spinal injury, rheumatoid arthritis with atlantoaxial subluxation)
  • Those with oropharyngeal obstructive disease (including tumor, foreign body)
  • Those who are expected prolonged intubation after surgery
  • Those who are pregnant

Treatment and study plan

Mallinckrodt endotracheal tube with a modified angle

Device

At sniffing position, the distal tip of a double-lumen tube is located at the patient's cricoid cartilage level and then the tube is bent at the intersection point of oral axis and the pharyngolaryngeal axis with an angle between the two axes.

Other names: Tube angle modification, ("MallinckrodeTM endotracheal tube", Covidien)

Mallinckrodt endobronchial tube with a conventional angle

Device

Inserting a manufacturer-provided conventional-angled tube

Other names: Mallinckrodt endobronchial tube, Covidien, with conventional-angled tube

Primary outcomes

  1. The time taken to intubate a double-lumen tube

    Time frame: within 60 sec

    The time taken to insert the tube begins when the laryngoscope passes the patient's lips and ends when the tube passes the vocal cords

Secondary outcomes

  1. The number of attempts needed for successful intubation

    Time frame: Intubation

  2. The time taken for the first attempt of intubation

    Time frame: within 60 sec

  3. Postoperative sore throat, hoarseness or dysphagia

    Time frame: 30 minutes and 24hours after extubation

Other outcomes

  1. Hemodynamic change

    Time frame: 1, 3 and 5 min after intubation

    We will record patient's heart rate, blood pressure and any used cardiovascular drugs at 1, 3 and 5 min after intubation

  2. Intubation difficulty scale score

    Time frame: At intubation

    Intubation difficulty Scale score is a function of seven parameters : number of attempts, number of operators, number of alternative techniques, cormack grade, lifting force needed, laryngeal pressure and vocal cord mobility.

    (Ref: Intubation Difficulty Scale, Anesthesiology 1997;87:1290-7)

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

Comparison of Individually Modified Angled Tube and Conventional Angled Tube in Double-lumen Endotracheal Tube Intubation: A Randomized Clinical Trial

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 15, 2014
Registry last updated
Feb 24, 2015

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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