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The Comparison of Glidescope® and the Direct Laryngoscopy in the Insertion of the Double Lumen Endotracheal Tube

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hung-Te Hsu (980393), Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01424605
First received: May 18, 2011
Last updated: August 26, 2011
Last verified: August 2011
History of Changes
  Purpose

Double-lumen bronchial tube (DLT) had been demonstrated to benefit for thoracic surgery and also played an important role to achieve one-lung ventilation (OLV) for exploring the surgical fields. However, compared with the single-lumen endotracheal tube (SLT), the DLT had larger OD (outer diameter), longer length, and was more complex in its structure. For avoiding oral tissue trauma and shortening the DLT intubating time, thus, an adequate and complete glottic viewing under laryngoscope was needed.

Over the past decade, several video-assisted laryngoscopes had been developed to facilitate the tracheal intubation in the difficult airway. Among these devices, the GlideScope® videolaryngoscope (GVL) (Verathon, Bothell, WA, USA) was a reusable video laryngoscope with a 60° curvature blade. A light source and a digital video camera were installed at the tip of the laryngoscope blade and the pictures of the glottis and the vocal cords were displayed on an LCD monitor. We could insert the endotracheal tube passing the vocal cords into the trachea more precisely and had less tissue damaging under the GVL's guidance.

Compared with direct MacIntosh laryngoscope, the GVL had been reported that it can decrease the intubation time and increase the successful rate of first intubation in normal and difficult airways. However, the efficacy of the GVL in intubating the DLT was unclear and had never been evaluated. Therefore, the aim of this study was to compare the intubation conditions, safety, and patient comfort between using the GVL and the direct Macintosh laryngoscope in a specific population of patients needed DLT intubation. Main outcome measures were intubation success rates and the time needed to intubate the DLT with the two devices.


Condition Intervention
Anesthesia Intubation Complication
 Procedure: DLT intubation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Comparison of Glidescope® and the Direct Laryngoscopy in the Insertion of the Double Lumen Endotracheal Tube

Further study details as provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:

Primary Outcome Measures:
  • Main outcome measure is the successful rate of the first intubation compared with the two devices [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The outcome measure is the time needed to inert the DLT compared with the two devices [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • The outcome measure were the hemodynamic parameters (such as mean blood pressure, and heart rate) compared with the two devices. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • The outcome measure is the incidence of complications (such as sorethroat, oral bleeding, and hypoxemia) compared with the two devices. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Hypoxemia is defined as the SPO2 is below 90%.


Enrollment: 60
Study Start Date: January 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DLT intubation Procedure: DLT intubation
Using a video-assisted laryngoscope to facilitate endotracheal tube intubation
Other Name: Intubation with GlideScope

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Anesthesiologists physical status I-III, ≧ 18 years of age, and needed double-lumen endotracheal tube (DLT) for thoracic surgery

Exclusion Criteria:

  • increased risk for regurgitation and pulmonary aspiration, history of gastroesophageal reflux, and pregnancy
  • a tracheostomy or prolonged ventilation on ICU was planned, patients were also excluded
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01424605

Locations
Taiwan
department of anesthesia, Kaohsiung medical university memorial hospital
Kaohsiung, Taiwan, 807
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
Investigators
Principal Investigator: Hung-Te Hsu, MD Department of anesthesia, Kaoshiung medical university hospital
  More Information

No publications provided

Responsible Party: Hung-Te Hsu (980393), visiting stuff , department of anesthesia, Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT01424605     History of Changes
Other Study ID Numbers: KMUH-IRB-980393, KMUH-IRB-980393
Study First Received: May 18, 2011
Last Updated: August 26, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:
left-sided double lumen bronchial tube
GlideScope videolaryngoscope
direct laryngoscope

ClinicalTrials.gov processed this record on May 19, 2013