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

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ClinicalTrials.gov Identifier: NCT01424605
Recruitment Status : Completed
First Posted : August 29, 2011
Last Update Posted : August 29, 2011
Sponsor:
Information provided by (Responsible Party):
Hung-Te Hsu (980393), Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Anesthesia Intubation Complication Procedure: DLT intubation Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : January 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia

Arm Intervention/treatment
Experimental: DLT intubation Procedure: DLT intubation
Using a video-assisted laryngoscope to facilitate endotracheal tube intubation
Other Name: Intubation with GlideScope




Primary Outcome Measures :
  1. Main outcome measure is the successful rate of the first intubation compared with the two devices [ Time Frame: 12 month ]

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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( Other Identifier: KaohsiungMU )
First Posted: August 29, 2011    Key Record Dates
Last Update Posted: August 29, 2011
Last Verified: August 2011

Keywords provided by Hung-Te Hsu (980393), Kaohsiung Medical University Chung-Ho Memorial Hospital:
left-sided double lumen bronchial tube
GlideScope videolaryngoscope
direct laryngoscope