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Completed

NCT Number: NCT01517204

The Efficacy of Trachway (R) Intubating Stylet in the Insertion of the Double Lumen Endobronchial Tube

The purpose of this study is to investigate the effects of Trachway(R) compared with direct laryngoscope in tracheal intubation of double-lumen endobronchial tube.

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Key information

Conditions

Anesthesia Intubation Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

department of anesthesia, Kaohsiung medical university memorial hospital

Kaohsiung City, Kaohsiung, 807, Taiwan

About this study

Intubation with the double-lumen endobronchial tube (DLT) remains a great challenge for anesthesiologists. Although new upper airway devices, such as Trachway (R), a video-assisted intubating stylet, had been developed for facilitating airway management.

The larger size and the complexity of DLT than single-lumen tube (SLT) makes the difficulties for DLT intubation. Therefore, the investigators designed this study to investigate the effects of Trachway(R)compared with direct laryngoscope in DLT intubation.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • patients with American Society of Anesthesiologists physical status I-III
  • More than 18 years of age
  • Requiring DLT for thoracic surgery

Exclusion criteria

  • risk of regurgitation and pulmonary aspiration
  • history of gastroesophageal reflux, pregnancy
  • scheduled tracheostomy and postoperative prolonged ventilation in ICU
  • patients with limited neck extension (< 35°)
  • a distance between the tip of the patient's mandible and hyoid bone of less than 7 cm
  • a sternomental distance of less than 12.5 cm with the head fully extended
  • mouth can not open

Treatment and study plan

Direct laryngoscope (Macintoish laryngoscope)

Device

Direct laryngoscope was used to facilitate the intubation of left-sided DLT.

Other names: Macintoish laryngoscope

Trachway(R) intubating stylet

Device

Trachway(R) intubating stylet was used to facilitate the intubation of left-sided DLT.

Other names: The Clarus Video System

Primary outcomes

  1. Main outcome measure is the successful rate of the first intubation

    Time frame: 12 month

Secondary outcomes

  1. The outcome measure is the time needed to insert the DLT

    Time frame: 12 months

  2. The outcome measure is mean blood pressure (MAP) during intubation period

    Time frame: 12 months

    MAP was measured before intubation, and after intubation 1, 3,and 5 min.

  3. The outcome measure is the heart rate (HR) during intubation period

    Time frame: 12 months

    HR was measured and recorded before intubation, and after intubation 1, 3,and 5 min.

  4. The outcome measure is the incidence of hypoxemia.

    Time frame: 12 months

    Hypoxemia was defined as SPO2 less than 90%. Hypoxemia was recorded during the period of intubation.

  5. The outcome measure is the incidence of sore throat.

    Time frame: 12 months

    Sore throat was observed and evaluated after extubation and patient regained consciousness.

  6. The outcome measure is the incidence of hoarseness.

    Time frame: 12 months

    Hoarseness was observed and evaluated after extubation and patient regained consciousness.

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Registry information

Official study title

The Comparison of Direct Laryngoscope and Trachway (R) Intubating Stylet in the Insertion of the Double Lumen Endobronchial Tube

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 25, 2012
Registry last updated
Sep 18, 2012

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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