Trial Outcomes & Findings for The New GlideRite DLT Stylet®: An Observational Study (NCT NCT01308918)
NCT ID: NCT01308918
Last Updated: 2012-03-26
Results Overview
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.
COMPLETED
50 participants
1 hour (Post intubation)
2012-03-26
Participant Flow
Between May 14th 2010 and January 17th 2011, 50 patients were enrolled in the study at the end of their pre-operative visit to the thoracic surgery department.
No enrolled participant were excluded from the study. All participants were included into the same group.
Participant milestones
| Measure |
GlideScope DLT Intubation With GlideRite DLT Stylet
The double lumen tube (DLT) is the technique of choice to obtain lung isolation. The GlideScope® (GLS, video laryngoscope allowing vizualisation of the airway and tube placement, has been used with a high level of success to assist positioning a single lumen tube (SLT) in normal situations and mainly in situations where the airway is considered or proven to be difficult.We have designed a new semi-rigid intubating stylet, the GlideRite DLT Stylet® (GR-DLT-S), which can be used for primary DLT intubation with the GLS. This pilot study was planned to observe the efficiency and the safety of the GR-DLT-S for primary insertion of DLT with the GLS in patients presenting a normal superior airway. After obtaining local IRB approval, 50 patients scheduled for thoracic surgery (non cardiac) via either thoracoscopy or thoracostomy at l'Institut de cardiologie et de pneumologie de Québec, were enrolled in this observational study.
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|---|---|
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Overall Study
STARTED
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50
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Overall Study
COMPLETED
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50
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The New GlideRite DLT Stylet®: An Observational Study
Baseline characteristics by cohort
| Measure |
GlideScope DLT Intubation
n=50 Participants
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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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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28 Participants
n=5 Participants
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Age, Categorical
>=65 years
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22 Participants
n=5 Participants
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Age Continuous
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58.7 years
STANDARD_DEVIATION 14.3 • n=5 Participants
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Sex: Female, Male
Female
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23 Participants
n=5 Participants
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Sex: Female, Male
Male
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27 Participants
n=5 Participants
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Region of Enrollment
Canada
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50 participants
n=5 Participants
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Body mass index
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26.8 kg/m2
STANDARD_DEVIATION 4.8 • n=5 Participants
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Weight
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74.3 kg
STANDARD_DEVIATION 14.5 • n=5 Participants
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PRIMARY outcome
Timeframe: 1 hour (Post intubation)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.
Outcome measures
| Measure |
GlideScope DLT Intubation
n=50 Participants
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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|---|---|
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Number of Successfull Primary Placement of the Double Lumen Tube.
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49 Participants
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SECONDARY outcome
Timeframe: 1 hour (Post intubation)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.
Outcome measures
| Measure |
GlideScope DLT Intubation
n=50 Participants
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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|---|---|
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Duration of the Intubating Process
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46.3 Seconds
Standard Deviation 32.3
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SECONDARY outcome
Timeframe: 1 hour (Post intubation)Outcome measures
| Measure |
GlideScope DLT Intubation
n=50 Participants
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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|---|---|
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Number of Attempt to Obtain a Successful Intubation
One (1) attempt
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37 Attempts
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Number of Attempt to Obtain a Successful Intubation
Two (2) attempts
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11 Attempts
|
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Number of Attempt to Obtain a Successful Intubation
Three (3) attempts
|
1 Attempts
|
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Number of Attempt to Obtain a Successful Intubation
Failure
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1 Attempts
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SECONDARY outcome
Timeframe: 1 hour (Post intubation)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 hour (Post intubation)Complications defined either as oxygen desaturation below 95%, oxygen desaturation below 90%, minor bleeding, anatomic lesion.
Outcome measures
| Measure |
GlideScope DLT Intubation
n=50 Participants
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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|---|---|
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Number of Complications Associated to the GlideRite DLT Stylet® Utilization
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3 Participants
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Adverse Events
GlideScope DLT Intubation
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Nathalie Gagne
Institut universitaire de cardiologie et de pneumologie de Quebec
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place