The New GlideRite DLT Stylet®: An Observational Study

NCT01308918 | Completed Results

• 1 other identifier: IUCPQ-20420
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Double Lumen Tube Intubation

Keywords

Thoracic surgery; Double lumen tube intubation; GlideScope; Stylet

Outcome Measures

Primary Outcomes (1)

• Number of Successfull Primary Placement of the Double Lumen Tube.

  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.

  1 hour (Post intubation)

Secondary Outcomes (4)

• Duration of the Intubating Process

  1 hour (Post intubation)

• Number of Attempt to Obtain a Successful Intubation

  1 hour (Post intubation)

• Correlation Between the Difficult Intubation Score and a Successful Intubation

  1 hour (Post intubation)

• Number of Complications Associated to the GlideRite DLT Stylet® Utilization

  1 hour (Post intubation)

Study Arms (1)

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.

Eligibility Criteria

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

You may qualify if:

• years old
• Elective thoracic surgery (non cardiac)

You may not qualify if:

• history of a difficult intubation in the past
• anticipated difficult mask ventilation
• anticipated difficult intubation according to the anesthesiologist's evaluation

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

Institut de cardiologie et de pneumologie de Québec

Québec, Quebec, G1V 4G5, Canada

Location

Related Publications (23)

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Results Point of Contact

• Title: Nathalie Gagne
• Organization: Institut universitaire de cardiologie et de pneumologie de Quebec

nathalie.gagne@criucpq.ulaval.ca

418 656-8711

Study Officials

• Jean S Bussières, MD

  Laval University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professeur de clinique

Study Record Dates

• First Submitted: March 1, 2011
• First Posted: March 4, 2011
• Study Start: May 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: March 26, 2012
• Results First Posted: March 26, 2012

Record last verified: 2012-02

Locations

CA (1)