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

NCT01424605 | Completed DMC

• 1 other identifier: KMUH-IRB-980393
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia Intubation Complication

Keywords

left-sided double lumen bronchial tube; GlideScope videolaryngoscope; direct laryngoscope

Outcome Measures

Primary Outcomes (1)

• Main outcome measure is the successful rate of the first intubation compared with the two devices

  12 month

Secondary Outcomes (3)

• The outcome measure is the time needed to inert the DLT compared with the two devices

  12 months

• The outcome measure were the hemodynamic parameters (such as mean blood pressure, and heart rate) compared with the two devices.

  12 months

• The outcome measure is the incidence of complications (such as sorethroat, oral bleeding, and hypoxemia) compared with the two devices.

  12 months

Study Arms (1)

DLT intubation

EXPERIMENTAL

Procedure: DLT intubation

Interventions

DLT intubation PROCEDURE

Using a video-assisted laryngoscope to facilitate endotracheal tube intubation

Also known as: Intubation with GlideScope

DLT intubation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

department of anesthesia, Kaohsiung medical university memorial hospital

Kaohsiung, Taiwan, 807, Taiwan

Location

MeSH Terms

Interventions

Intubation

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques

Study Officials

• Hung-Te Hsu, MD

  Department of anesthesia, Kaoshiung medical university hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: visiting stuff , department of anesthesia

Study Record Dates

• First Submitted: May 18, 2011
• First Posted: August 29, 2011
• Study Start: January 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: August 29, 2011

Record last verified: 2011-08

Locations

TW (1)