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Completed

NCT Number: NCT02364622

The Effects of Flexible Intubating Stylet in the Accurate Placement of Double-lumen Endobronchial Tube

The purpose of this study is to determine whether using the flexible Trachway(R) intubating stylet could facilitate and promote the accurate placement of double-lumen endobronchial tube.

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Key information

Conditions

Intubation Complication Intubation, Difficult

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Medical University chung-Ho Memorial Hospital

Kaohsiung City, Taiwan, 803

About this study

How to accurately place the left-sided double-lumen endobronchial tube (DLT) in the trachea remains a great challenge for anesthesiologists. Although new upper airway devices, such as flexible Trachway (R), a video-assisted intubating stylet, had been developed for facilitating airway management, the larger size and the complexity of DLT makes the difficulties for accurate placement of DLT blindly. Therefore, the investigators designed this study to investigate the effects of flexibleTrachway(R) intubating stylet in the placement of left-sided DLT in the trachea.

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

Tranditional fiberoptic bronchoscopy

Device

The accurate placement of left-sided DLT into the left main bronchus was facilitated by tranditional fiberoptic bronchoscopy.

Modified fiberoptic bronchoscopy

Device

The accurate placement of left-sided DLT into the left main bronchus was facilitated by modified fiberoptic bronchoscopy

Flexible Trachway intubating stylet

Device

The accurate placement of left-sided DLT into the left main bronchus was faciliated by using flexible Trachway intubating stylet.

Primary outcomes

  1. Main outcome measure is the successful rate of the first accurate placement of left-sided DLT in the trachea

    Time frame: 12 month

Secondary outcomes

  1. The outcome measure is the time needed to accurate placement of left-sided DLT in the trachea

    Time frame: 12 month

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

    Time frame: 12 month

    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 month

    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 month

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

  5. The outcome measure is the incidence of sore throat

    Time frame: 12 month

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

  6. The outcome measure is the incidence of hoarseness

    Time frame: 12 month

    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 Effects of Flexible Trachway(R) Intubating Stylet in the Accurate Placement of Left-sided Double-lumen Endobronchial Tube

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 18, 2015
Registry last updated
Feb 18, 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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