Videolaryngoscopes for Double Lumen Tube Intubations

NCT02305667 | Completed DMC

• 1 other identifier: ANE-2014-11-27
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Compared with the Macintosh laryngoscopy (MAC), the videolaryngoscopes (VL) provide superior glottis views and longer times to double-lumen tube (DLT) intubation. We hypothesize that the use of the King Vision™ (KVL) and the Airtraq® VLs may reduce the time for DLT intubation compared with the Glidescope® (GVL) and MAC in patients undergoing thoracic procedures. Methods: One hundred-forty patients who will be scheduled for elective thoracic procedures using the DLT for one-lung ventilation will be randomly assigned to one of four groups (n=35 per group) to intubate using the MAC, GVL, Airtraq®, or KVL. Time to DLT intubation, glottis view, ease of intubation, number of optimization maneuvers, and failure to intubation (\>150 s.) will be recorded.

Conditions

Thoracic Surgery; Need for Double Lumen Tubes

Keywords

Laryngoscope; Macintosh; Glidescope®; King Vision™; Airtraq®; intubation; double lumen tube

Outcome Measures

Primary Outcomes (1)

• Time to the duration of endobronchial intubation

  defined as the time from when the laryngoscope entered between the patient's lips until successful DLT placement (regardless of the number of attempts).\[

  3 minutes after laryngoscopy

Secondary Outcomes (7)

• best obtained glottis view during laryngoscopy

  30 sec after laryngosocopy

• ease of endobronchial intubation

  30 sec after laryngosocopy

• number of optimization maneuvers

  150 sec after laryngosocopy

• number of the 'backwards upwards rightwards pressure' (BURP) maneuver

  150 sec after laryngosocopy

• failure rate for double lumen tube intubation

  150 sec after laryngosocopy

Study Arms (4)

Macintosh

PLACEBO COMPARATOR

Double lumen tube intubation using Macintosh laryngoscope

Device: Macintosh

Glidescope®

ACTIVE COMPARATOR

Double lumen tube intubation using Glidescope® videolaryngoscope

Device: Glidescope®

Airtraq®

ACTIVE COMPARATOR

Double lumen tube intubation using Airtraq® videolaryngoscope

Device: Airtraq®

King Vision™

ACTIVE COMPARATOR

Double lumen tube intubation using King Vision™ videolaryngoscope

Device: King Vision™

Interventions

Macintosh DEVICE

double lumen tube intubation using the Macintosh laryngoscope

Macintosh

Glidescope® DEVICE

double lumen tube intubation using the Glidescope® videolaryngoscope. The distal portion of a left-sided DLT will be angulated to the right concealing the distal orifice of the tracheal lumen. The DLT will be advanced directly through the vocal cords after initial 90° clockwise rotation, the stylet will be removed, and then the DLT will be advanced gently while rotating in a 180° couterclockwise direction

Glidescope®

Airtraq® DEVICE

double lumen tube intubation using the Airtraq® videolaryngoscope.

Airtraq®

King Vision™ DEVICE

double lumen tube intubation using the King Vision™ videolaryngoscope. the distal 21 cm of the left-sided DLT will be bended to replicate the curve of the non-channeled blade and the proximal curve of the DLT remains directed to the right side. Then, after initial 90° clockwise rotation, the bronchial cuff passes through the vocal cords, the stylet of the DLT will be withdrawn and the DLT will be rotated 180°counterclockwise while advancing the DLT to the desired depth.

King Vision™

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists' physical status II/III
• Elective thoracic procedures

You may not qualify if:

• New York Heart Association (NYHA) functional classification class III to IV
• forced expiratory volume in 1 s (FEV1) less than 50% of predicted values
• forced vital capacity (FVC) less than 50% of predicted values
• severe asthma
• pregnancy
• risk of regurgitation
• risk of pulmonary aspiration
• history of gastro-esophageal reflux
• body mass index more than 40 kg m-2
• anticipated difficult intubation
• preoperative postoperative ventilatory support
• planned postoperative ventilatory support

Sponsors & Collaborators

• Imam Abdulrahman Bin Faisal University: lead

Study Sites (1)

King Fahd Hospital of the University

Khobar, Eastern Province, 31952, Saudi Arabia

Location

Study Officials

• Mohamed R El Tahan, MD

  Associate Professor at Anesthesiology Dept

  PRINCIPAL INVESTIGATOR

• Alaa khidr, MD

  Imam Abdulrahman Bin Faisal University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2014
• First Posted: December 2, 2014
• Study Start: May 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 24, 2017

Record last verified: 2017-01

Locations

SA (1)