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The New GlideRite DLT Stylet®: An Observational Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jean Bussières, Laval University
ClinicalTrials.gov Identifier:
NCT01308918
First received: March 1, 2011
Last updated: February 21, 2012
Last verified: February 2012
  Purpose

Thoracic surgeries usually require lung isolation techniques. Double-lumen tube (DLT), either right or left sided, is the most frequent tool used to realize this technique. In front of difficult airways, the use of videolaryngoscopy (GllideScope®) (GS) may advantageous. Hypothesis: We will test the hypothesis that under GS, the use of a specific semi-rigid stylet is efficacious to insert a DLT, and also safe. The increased rigidity of the GlideRite DLT Stylet for double-lumen tubes will enable the DLT to keep its form while it is railroaded into superior airways. This new stylet combined to Glidescope® utilization will increase the rate of successful intubation, especially in patients with difficult airways. This technique will allow us to directly intubate with a DLT using the GlideScope®, avoiding a beforehand SLT intubation and airway exchange catheter use. Consequently, its use could reduce risks associated to blind insertion of DLT with airway exchange catheter (airway traumatism and pulmonary aspiration). Primary objective: To determine the GlideRite DLT Stylet efficiency for double-lumen tubes orotracheal intubation under videolaryngoscopy (GllideScope®). Secondary objectives: to time successful intubation, to count the number of intubation attempt, to verify the influence of difficult intubation score (DIS) on successful intubation, and to log complications associated to its use. Exclusion criterion are: previous history of difficult intubation, anticipated difficult mask ventilation, and anticipated difficult intubation. Conclusion: The aim of using the GlideRite DLT Stylet for an orotracheal intubation under videolaryngoscopy is to allow the primary intubation with a DLT in patients with abnormal superior airways. These anomalies are more and more frequent. Alternative airway management implies more manipulations, leading to an increased risk of oxygen desaturation, lung aspiration, and airway lesions. Moreover, these alternatives take more time than using a Glidescope, which can be compare to direct laryngoscopy. The development of a semi-rigid stylet, such as the GlideRite DLT Stylet, is a great advancement in the management of primary intubation with DLT, mainly in face of difficult airways.


Condition
Double Lumen Tube Intubation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The New GlideRite DLT Stylet®: An Observational Study

Further study details as provided by Laval University:

Primary Outcome Measures:
  • Number of Successfull Primary Placement of the Double Lumen Tube. [ Time Frame: 1 hour (Post intubation) ] [ Designated as safety issue: No ]
    To evaluate the number of participants where GlideRite DLT Stylet® associated to the video laryngoscopy (GlideScope®)allowed the primary placement of the double lumen tube into their trachea.


Secondary Outcome Measures:
  • Duration of the Intubating Process [ Time Frame: 1 hour (Post intubation) ] [ Designated as safety issue: No ]
    The timer was started when the GLS blade was inserted between the lips and stopped when the proximal part of the tracheal cuff was passed through the vocal cords. When a patient had teeth at the superior jaw, the DLT was first inserted into the mouth prior to the insertion of the GLS blade in order to avoid rupturing the tracheal cuff. For these cases, the timer was started when the DLT was inserted between the lips.

  • Number of Attempt to Obtain a Successful Intubation [ Time Frame: 1 hour (Post intubation) ] [ Designated as safety issue: No ]
  • Correlation Between the Difficult Intubation Score and a Successful Intubation [ Time Frame: 1 hour (Post intubation) ] [ Designated as safety issue: No ]
  • Number of Complications Associated to the GlideRite DLT Stylet® Utilization [ Time Frame: 1 hour (Post intubation) ] [ Designated as safety issue: Yes ]
    Complications defined either as oxygen desaturation below 95%, oxygen desaturation below 90%, minor bleeding, anatomic lesion.


Enrollment: 50
Study Start Date: May 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
GlideScope DLT intubation
Patients having a thoracic surgery (non cardiac) via either thoracoscopy or thoracostomy. Patients were all 18 years old or over, and have read, understood and signed an informed consent at the preoperative evaluation or on surgery morning.

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

50 patients having an elective thoracic surgery (non cardiac) via either thoracopscopy or thoracostomy. Patients were all 18 years old or over, and have read, understood and signed an informed consent at the preoperative evaluation or on surgery morning.

Criteria

Inclusion Criteria:

  • 18 years old
  • Elective thoracic surgery (non cardiac)

Exclusion Criteria:

  • history of a difficult intubation in the past
  • anticipated difficult mask ventilation
  • anticipated difficult intubation according to the anesthesiologist's evaluation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01308918

Locations
Canada, Quebec
Institut de cardiologie et de pneumologie de Québec
Quebec City, Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Laval University
Investigators
Principal Investigator: Jean S Bussières, MD Laval University
  More Information

Publications:

Responsible Party: Jean Bussières, Professeur de clinique, Laval University
ClinicalTrials.gov Identifier: NCT01308918     History of Changes
Other Study ID Numbers: IUCPQ-20420
Study First Received: March 1, 2011
Results First Received: June 22, 2011
Last Updated: February 21, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Laval University:
Thoracic surgery
Double lumen tube intubation
GlideScope
Stylet

ClinicalTrials.gov processed this record on November 20, 2014