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Completed

NCT Number: NCT03846713

Thermosoftening of Double-lumen Tube for Airway Exchanger Catheter

The purpose of this study is to investigate the effect of double-lumen tube thermal-softening before intubation on the success rate of tube exchange by airway exchange catheter.

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Key information

Conditions

Intubation Complication Hoarseness Infections Laryngeal Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Pharyngitis Respiration Disorders Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Respiratory Sore Throat Stomatognathic Diseases Voice Disorders

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 110-744, 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 that requires bronchoscopy study before the placement of double-lumen tubes

Exclusion criteria

  • Preoperative hoarseness or a sore throat
  • History of upper airway diseases
  • Anticipated difficult airway

Treatment and study plan

non-thermosoftening

Procedure

By using airway exchange catheter, tube exchange is performed from single to double lumen tube that was put into normal saline at room temperature.

thermosoftening

Procedure

By using airway exchange catheter, tube exchange is performed from single to double lumen tube that was put into warm normal saline (40°C).

Primary outcomes

  1. Time to intubate

    Time frame: Intraoperative (During exchanging single- to double-lumen tube)

    Length of time to exchange endotracheal tube from single- to double-lumen tube using airway exchange catheter.

Secondary outcomes

  1. Postoperative hoarseness (4-points scoring)

    Time frame: up to 48 hours after surgery

  2. postoperative sore throat (4-points scoring)

    Time frame: up to 48 hours after surgery

  3. Vocal cord injuries assessed by videolaryngoscope

    Time frame: up to 1 hour after double-lumen tube extubation

    vocal cord injuries observed after tube-exchange

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Effect of Thermal-softening of Double-lumen Endobronchial Tubes on Success Rate of Airway Exchange Catheter

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 20, 2019
Registry last updated
Jun 25, 2025

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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