Double Lumen Tube IntubationNCT01308918
The New GlideRite DLT Stylet®: An Observational Study
An observational study of Double Lumen Tube Intubation, run by Laval University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Double Lumen Tube Intubation
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- May 2010to Jan 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 18 years old
- Elective thoracic surgery (non cardiac)
Who cannot join
- history of a difficult intubation in the past
- anticipated difficult mask ventilation
- anticipated difficult intubation according to the anesthesiologist's evaluation
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut de cardiologie et de pneumologie de Québec
Québec, Quebec, G1V 4G5
About this study
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.
Read the detailed description
INTRODUCTION Anesthesia in thoracic surgery (non cardiac) often requires pulmonary isolation techniques in order to facilitate the surgery, to protect a healthy lung, and to control the ventilation. The double lumen tube (DLT), in right and left version, is the technique of choice to obtain lung isolation, whereas the bronchial blocker can also be used.
Double-lumen tube One-lung ventilation is required in most of thoracic surgeries. Many strategies can be used to achieve lung isolation: 1) use of endobronchial tube, 2) use of a single-lumen tube (SLT) and a bronchial blocker (BB),or 3) use of a double-lumen tube (DLT). There is many advantages of using a DLT: easier to position, shorter time of lung collapsing and re-expansion than BB, each lung can be suctioned/ventilated separately, and less subject to displacement than BB. Since no medical instrument is perfect, DLT has also some inconvenient: DLT are larger, and less compliant than a SLT. They also have two cuffs, one bronchial and another one tracheal. The latter is causing problem when intubating patients with teeth at the superior jaw. Precautions have to be taken to avoid rupturing the tracheal cuff. These characteristics are exaggerated when anesthesiologist faces a patient with a difficult airway. These cases are usually managed by first proceeding to a standard intubation with a SLT, second, use an airway exchange catheter (AEC) to withdraw the SLT, and then, advance the DLT into the proper position. Thereafter, the gold standard is to confirm the DLT position with a fiberoptic bronchoscope (FOB). If direct laryngoscopy provides poor glottis visualization, another option is to proceed to a FOB-assisted DLT intubation.
Video laryngoscopes Over the last decade, video laryngoscopes have been developed to handle difficult airway management. They have the advantage of improving Cormack-Lehane (CL) grade over direct laryncoscopy. Many manufacturers distribute video laryngoscopes: the Storz® C-MAC™, the McGrath® Series-5™, and the GlideScope® Video Laryngoscope™ (GVL) are few examples. This latter is frequently used in our centre to allow tracheal intubation with a SLT in numerous situations where conventional laryngoscopy is not possible. The GVL requires the same technique than a direct laryngoscopy without a line of sight, turning CL Grade III or IV into CL Grade I or II.
Stylet To facilitate the endotracheal tube (ETT) insertion using the GVL, either a semi-rigid or a malleable stylet must be used. There is also a lot of discussion about the best stylet configuration allowing the tip of the ETT to be positioned at the glottis opening and advancing the tube into the trachea, but no consensus has been obtained yet. Difficult airway management may be optimized by shaping the SLT using a malleable stylet, directing the ETT through vocal cords. The main problem of malleable stylet is that it loses its initial shape when the ETT goes through narrow airways. It is why many clinicians prefer the semi-rigid stylet when using the GlideScope®. Double-lumen tubes are already supplied with a malleable aluminum stylet in order for them to maintain their initial shape, and some authors found that accuracy of placement have improved when it is retained into a left-DLT for the entire intubation procedure.
New semi-rigid stylet Video laryngoscopes have been designed to be mostly used with SLT, but recent publications have suggested using a GlideScope® for primary DLT placement in difficult airways, as described by Hernandez, A et al. in 2005 and Chen, A et al. in 2008. Even if DLT are provided with a stylet, the technique of intubation with the GVL remains difficult, mainly because the aluminum stylet is too malleable. Verathon Inc. has marketed the GlideRite® rigid stylet, especially design to use with the GlideScope®. Its length fits most of SLT, its shape is adapted to the GVL's curvature, and the curvature can be modified to accommodate a difficult airway only with intentional movement. In collaboration with Verathon Inc., we have designed a new semi-rigid intubating stylet that can be use for primary DLT intubation with the Glidescope® Videolaryngoscope, the GlideRite DLT Stylet®. This improved intubating tool is sharing the same curve but is longer than the GlideRite® rigid stylet. It present a specific handle to fit with the DLT and to orient the distal extremity into the right or left bronchus. The new stylet fits 35 to 41 French, left of right-sided DLTs. Anticipated benefits of this new design are a shorter time required to position the DLT, less intubating attempt, lower risk of trauma to the airway, lower risk of desaturation and, lower risk of tracheal cuff' rupture, resulting in a one-step lung isolation.
HYPOTHESIS We believe that, under video laryngoscopy, the use of the semi-rigid GlideRite DLT Stylet® for primary insertion of DLT is possible.
The gain of rigidity that we have developed for the GlideRite DLT Stylet® imposes its shape to the DLT, and conserves it while the tube is guided through the superior airway. We hope that the combination of both the GlideScope® and the new semi-rigid stylet will increase the number of successful primary intubation with a double lumen tube. Furthermore, its utilization could drastically decrease associated risks of blind DLT intubation with an AEC. These risks are oxygen desaturation, pulmonary aspiration, and superior airway trauma.
OBJECTIVES The primary objective of this observational study is to determine the GlideRite DLT Stylet® efficiency during endotracheal intubation with a double lumen tube under video laryngoscopy (GlideScope®).
The secondary objectives are:
- To time the intubating process.
- To count the number of attempt to obtain a successful intubation.
- To verify the correlation between the difficult intubation score and a successful intubation.
- To note all complications associated to the GlideRite DLT Stylet® utilization.
METHODS After obtaining local REB approval, 50 patients having a thoracic surgery (non cardiac) via either thoracoscopy or thoracostomy, were enrolled to this observational study between May 14th 2010 and January 17th 2011.
Intraoperative proceeding Before anesthesia was induced, patients were pre-oxygenated in order to obtain an inspired-expired O2 gradient ≤10%. Anesthesia was performed in conformity with local practice standards. Curarization was achieved by injecting a dose of ≥1.0 mg/kg (ideal body weight) of rocuronium (Zémuron®, Merck \& Co., Whitehouse Station, NJ, USA). If mask ventilation was proven to be difficult, the patient was excluded from the study. The malleable stylet was removed from the DLT (Broncho-Cath R- or L-DLT, 35 to 41Fr, Mallinckrodt Inc, St-Louis, MO, USA) and replaced with a GlideRite DLT Stylet® (Verathon Medical ULC, Burnaby, BC, Canada). Before proceeding to the intubation, curarization level was verified with a neuromuscular stimulator, absence of thumb movement when a train-of-four was applied allowed us to begin the protocol.
The timer was started when either the GlideScope® blade (Verathon Medical ULC, Burnaby, BC, Canada) was inserted between the lips and stopped when the tracheal cuff was passed through the vocal cords. In case of patients presenting with upper teeth, the timer was started when the DLT was inserted between the lips. Immediately after intubation, intratracheal position was confirmed with FOB. When a patient had teeth at the superior jaw, the DLT was inserted first into the mouth in order to avoid rupturing the tracheal cuff. External larynx manipulations were allowed at all time. If after one (1) minute, the intubation was not successful, the anesthesiologist could then modify the stylet shape. If after two (2) minutes, the intubation was still not achieved, the DLT and GVL blade were withdrawn, and mask ventilation was started again. At that time, the anesthesiologist could use the intubation technique of his choice. The position of the DLT was confirmed by the visualization of the trachea through the FOB. Throughout this process, if oxygen saturation dropped below 94%, mask ventilation was started to increase saturation up to 98% or more before another intubation could be attempted. If oxygen saturation dropped below 90%, mask ventilation was started to increase saturation up to 98% or more, the patient was then excluded from the study, and the anesthesiologist could use the intubation technique of his choice.
Statistical analysis Data obtained during the preoperative period will be correlated with the success rate, the time to achieve a successful intubation and, the number of attempt.
- Conditions
- Double Lumen Tube Intubation
- Keywords
- Thoracic surgery, Double lumen tube intubation, GlideScope, Stylet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour (Post intubation)
Secondary outcomes (4)
Duration of the Intubating Process
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.
Measured: 1 hour (Post intubation)
Number of Attempt to Obtain a Successful Intubation
Measured: 1 hour (Post intubation)
Correlation Between the Difficult Intubation Score and a Successful Intubation
Measured: 1 hour (Post intubation)
Number of Complications Associated to the GlideRite DLT Stylet® Utilization
Complications defined either as oxygen desaturation below 95%, oxygen desaturation below 90%, minor bleeding, anatomic lesion.
Measured: 1 hour (Post intubation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2011 (estimated)
- Study startMay 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Double Lumen Tube IntubationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean Bussières, Laval University
- Investigators
- Jean S Bussières, MD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01308918
- Sponsor's protocol ID
- IUCPQ-20420
- Status last verified
- Feb 2012
- First submitted
- 1 Mar 2011
- Last updated
- 26 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Aps C, Towey RM. Experiences with fibre-optic bronchoscopic positioning of single-lumen endobronchial tubes. Anaesthesia. 1981 Apr;36(4):415-8. doi: 10.1111/j.1365-2044.1981.tb10250.x. No abstract available.
PubMed 7246992Campos JH. An update on bronchial blockers during lung separation techniques in adults. Anesth Analg. 2003 Nov;97(5):1266-1274. doi: 10.1213/01.ANE.0000085301.87286.59.
PubMed 14570636Cohen E. Recommendations for airway control and difficult airway management in thoracic anesthesia and lung separation procedures. Are we ready for the challenge? Minerva Anestesiol. 2009 Jan-Feb;75(1-2):3-5. Epub 2008 Nov 28. No abstract available.
PubMed 19039300Brodsky JB. Lung separation and the difficult airway. Br J Anaesth. 2009 Dec;103 Suppl 1:i66-75. doi: 10.1093/bja/aep262.
PubMed 20007992Fortier G, St-Onge S, Bussieres J. Two other simple methods to protect the tracheal cuff of a double-lumen tube. Anesth Analg. 1999 Oct;89(4):1064. doi: 10.1097/00000539-199910000-00047. No abstract available.
PubMed 10512293Perlin DI, Hannallah MS. Double-lumen tube placement in a patient with a difficult airway. J Cardiothorac Vasc Anesth. 1996 Oct;10(6):787-8. doi: 10.1016/S1053-0770(96)80208-4. No abstract available.
PubMed 8910162Cooper RM. Use of a new videolaryngoscope (GlideScope) in the management of a difficult airway. Can J Anaesth. 2003 Jun-Jul;50(6):611-3. doi: 10.1007/BF03018651.
PubMed 12826557Rope TC, Loughnan BA, Vaughan DJ. Videolaryngoscopy--an answer to difficult laryngoscopy? Eur J Anaesthesiol. 2008 May;25(5):434-5. doi: 10.1017/S0265021507002931. No abstract available.
PubMed 18377671Turkstra TP, Harle CC, Armstrong KP, Armstrong PM, Cherry RA, Hoogstra J, Jones PM. The GlideScope-specific rigid stylet and standard malleable stylet are equally effective for GlideScope use. Can J Anaesth. 2007 Nov;54(11):891-6. doi: 10.1007/BF03026792.
PubMed 17975233Neustein SM. The GlideScope-specific rigid stylet to facilitate tracheal intubation with the Glidescope. Can J Anaesth. 2008 Mar;55(3):196-7; author reply 197. doi: 10.1007/BF03016103. No abstract available.
PubMed 18310639van Zundert A, Maassen R, Lee R, Willems R, Timmerman M, Siemonsma M, Buise M, Wiepking M. A Macintosh laryngoscope blade for videolaryngoscopy reduces stylet use in patients with normal airways. Anesth Analg. 2009 Sep;109(3):825-31. doi: 10.1213/ane.0b013e3181ae39db.
PubMed 19690253Maassen R, Lee R, Hermans B, Marcus M, van Zundert A. A comparison of three videolaryngoscopes: the Macintosh laryngoscope blade reduces, but does not replace, routine stylet use for intubation in morbidly obese patients. Anesth Analg. 2009 Nov;109(5):1560-5. doi: 10.1213/ANE.0b013e3181b7303a. Epub 2009 Aug 27.
PubMed 19713258Dupanovic M, Diachun CA, Isaacson SA, Layer D. Intubation with the GlideScope videolaryngoscope using the "gear stick technique". Can J Anaesth. 2006 Feb;53(2):213-4. doi: 10.1007/BF03021834. No abstract available.
PubMed 16434769Muallem M, Baraka A. Tracheal intubation using the GlideScope with a combined curved pipe stylet, and endotracheal tube introducer. Can J Anaesth. 2007 Jan;54(1):77-8. doi: 10.1007/BF03021905. No abstract available.
PubMed 17197473Jones PM, Turkstra TP, Armstrong KP, Armstrong PM, Cherry RA, Hoogstra J, Harle CC. Effect of stylet angulation and endotracheal tube camber on time to intubation with the GlideScope. Can J Anaesth. 2007 Jan;54(1):21-7. doi: 10.1007/BF03021895.
PubMed 17197464
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The New GlideRite DLT Stylet®: An Observational Study
- ClinicalTrials.gov ID
- NCT01308918
- Acronym / sponsor ID
- IUCPQ-20420
- Conditions
- Double Lumen Tube Intubation
- Keywords
- Thoracic surgery, Double lumen tube intubation, GlideScope, Stylet
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 4 Mar 2011 (estimated)
- Results
- Posted 26 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
INTRODUCTION Anesthesia in thoracic surgery (non cardiac) often requires pulmonary isolation techniques in order to facilitate the surgery, to protect a healthy lung, and to control the ventilation. The double lumen tube (DLT), in right and left version, is the technique of choice to obtain lung isolation, whereas the bronchial blocker can also be used.
Double-lumen tube One-lung ventilation is required in most of thoracic surgeries. Many strategies can be used to achieve lung isolation: 1) use of endobronchial tube, 2) use of a single-lumen tube (SLT) and a bronchial blocker (BB),or 3) use of a double-lumen tube (DLT). There is many advantages of using a DLT: easier to position, shorter time of lung collapsing and re-expansion than BB, each lung can be suctioned/ventilated separately, and less subject to displacement than BB. Since no medical instrument is perfect, DLT has also some inconvenient: DLT are larger, and less compliant than a SLT. They also have two cuffs, one bronchial and another one tracheal. The latter is causing problem when intubating patients with teeth at the superior jaw. Precautions have to be taken to avoid rupturing the tracheal cuff. These characteristics are exaggerated when anesthesiologist faces a patient with a difficult airway. These cases are usually managed by first proceeding to a standard intubation with a SLT, second, use an airway exchange catheter (AEC) to withdraw the SLT, and then, advance the DLT into the proper position. Thereafter, the gold standard is to confirm the DLT position with a fiberoptic bronchoscope (FOB). If direct laryngoscopy provides poor glottis visualization, another option is to proceed to a FOB-assisted DLT intubation.
Video laryngoscopes Over the last decade, video laryngoscopes have been developed to handle difficult airway management. They have the advantage of improving Cormack-Lehane (CL) grade over direct laryncoscopy. Many manufacturers distribute video laryngoscopes: the Storz® C-MAC™, the McGrath® Series-5™, and the GlideScope® Video Laryngoscope™ (GVL) are few examples. This latter is frequently used in our centre to allow tracheal intubation with a SLT in numerous situations where conventional laryngoscopy is not possible. The GVL requires the same technique than a direct laryngoscopy without a line of sight, turning CL Grade III or IV into CL Grade I or II.
Stylet To facilitate the endotracheal tube (ETT) insertion using the GVL, either a semi-rigid or a malleable stylet must be used. There is also a lot of discussion about the best stylet configuration allowing the tip of the ETT to be positioned at the glottis opening and advancing the tube into the trachea, but no consensus has been obtained yet. Difficult airway management may be optimized by shaping the SLT using a malleable stylet, directing the ETT through vocal cords. The main problem of malleable stylet is that it loses its initial shape when the ETT goes through narrow airways. It is why many clinicians prefer the semi-rigid stylet when using the GlideScope®. Double-lumen tubes are already supplied with a malleable aluminum stylet in order for them to maintain their initial shape, and some authors found that accuracy of placement have improved when it is retained into a left-DLT for the entire intubation procedure.
New semi-rigid stylet Video laryngoscopes have been designed to be mostly used with SLT, but recent publications have suggested using a GlideScope® for primary DLT placement in difficult airways, as described by Hernandez, A et al. in 2005 and Chen, A et al. in 2008. Even if DLT are provided with a stylet, the technique of intubation with the GVL remains difficult, mainly because the aluminum stylet is too malleable. Verathon Inc. has marketed the GlideRite® rigid stylet, especially design to use with the GlideScope®. Its length fits most of SLT, its shape is adapted to the GVL's curvature, and the curvature can be modified to accommodate a difficult airway only with intentional movement. In collaboration with Verathon Inc., we have designed a new semi-rigid intubating stylet that can be use for primary DLT intubation with the Glidescope® Videolaryngoscope, the GlideRite DLT Stylet®. This improved intubating tool is sharing the same curve but is longer than the GlideRite® rigid stylet. It present a specific handle to fit with the DLT and to orient the distal extremity into the right or left bronchus. The new stylet fits 35 to 41 French, left of right-sided DLTs. Anticipated benefits of this new design are a shorter time required to position the DLT, less intubating attempt, lower risk of trauma to the airway, lower risk of desaturation and, lower risk of tracheal cuff' rupture, resulting in a one-step lung isolation.
HYPOTHESIS We believe that, under video laryngoscopy, the use of the semi-rigid GlideRite DLT Stylet® for primary insertion of DLT is possible.
The gain of rigidity that we have developed for the GlideRite DLT Stylet® imposes its shape to the DLT, and conserves it while the tube is guided through the superior airway. We hope that the combination of both the GlideScope® and the new semi-rigid stylet will increase the number of successful primary intubation with a double lumen tube. Furthermore, its utilization could drastically decrease associated risks of blind DLT intubation with an AEC. These risks are oxygen desaturation, pulmonary aspiration, and superior airway trauma.
OBJECTIVES The primary objective of this observational study is to determine the GlideRite DLT Stylet® efficiency during endotracheal intubation with a double lumen tube under video laryngoscopy (GlideScope®).
The secondary objectives are:
- To time the intubating process.
- To count the number of attempt to obtain a successful intubation.
- To verify the correlation between the difficult intubation score and a successful intubation.
- To note all complications associated to the GlideRite DLT Stylet® utilization.
METHODS After obtaining local REB approval, 50 patients having a thoracic surgery (non cardiac) via either thoracoscopy or thoracostomy, were enrolled to this observational study between May 14th 2010 and January 17th 2011.
Intraoperative proceeding Before anesthesia was induced, patients were pre-oxygenated in order to obtain an inspired-expired O2 gradient ≤10%. Anesthesia was performed in conformity with local practice standards. Curarization was achieved by injecting a dose of ≥1.0 mg/kg (ideal body weight) of rocuronium (Zémuron®, Merck \& Co., Whitehouse Station, NJ, USA). If mask ventilation was proven to be difficult, the patient was excluded from the study. The malleable stylet was removed from the DLT (Broncho-Cath R- or L-DLT, 35 to 41Fr, Mallinckrodt Inc, St-Louis, MO, USA) and replaced with a GlideRite DLT Stylet® (Verathon Medical ULC, Burnaby, BC, Canada). Before proceeding to the intubation, curarization level was verified with a neuromuscular stimulator, absence of thumb movement when a train-of-four was applied allowed us to begin the protocol.
The timer was started when either the GlideScope® blade (Verathon Medical ULC, Burnaby, BC, Canada) was inserted between the lips and stopped when the tracheal cuff was passed through the vocal cords. In case of patients presenting with upper teeth, the timer was started when the DLT was inserted between the lips. Immediately after intubation, intratracheal position was confirmed with FOB. When a patient had teeth at the superior jaw, the DLT was inserted first into the mouth in order to avoid rupturing the tracheal cuff. External larynx manipulations were allowed at all time. If after one (1) minute, the intubation was not successful, the anesthesiologist could then modify the stylet shape. If after two (2) minutes, the intubation was still not achieved, the DLT and GVL blade were withdrawn, and mask ventilation was started again. At that time, the anesthesiologist could use the intubation technique of his choice. The position of the DLT was confirmed by the visualization of the trachea through the FOB. Throughout this process, if oxygen saturation dropped below 94%, mask ventilation was started to increase saturation up to 98% or more before another intubation could be attempted. If oxygen saturation dropped below 90%, mask ventilation was started to increase saturation up to 98% or more, the patient was then excluded from the study, and the anesthesiologist could use the intubation technique of his choice.
Statistical analysis Data obtained during the preoperative period will be correlated with the success rate, the time to achieve a successful intubation and, the number of attempt.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 18 years old
- Elective thoracic surgery (non cardiac)
Key exclusion criteria (3 listed)
- history of a difficult intubation in the past
- anticipated difficult mask ventilation
- anticipated difficult intubation according to the anesthesiologist's evaluation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Successfull Primary Placement of the Double Lumen Tube.
Time frame: 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.
4 secondary outcomes
Duration of the Intubating Process
Time frame: 1 hour (Post intubation)
Number of Attempt to Obtain a Successful Intubation
Time frame: 1 hour (Post intubation)
Correlation Between the Difficult Intubation Score and a Successful Intubation
Time frame: 1 hour (Post intubation)
Number of Complications Associated to the GlideRite DLT Stylet® Utilization
Time frame: 1 hour (Post intubation)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 7246992Aps C, Towey RM. Experiences with fibre-optic bronchoscopic positioning of single-lumen endobronchial tubes. Anaesthesia. 1981 Apr;36(4):415-8. doi: 10.1111/j.1365-2044.1981.tb10250.x. No abstract available.
- Background: PubMed 14570636Campos JH. An update on bronchial blockers during lung separation techniques in adults. Anesth Analg. 2003 Nov;97(5):1266-1274. doi: 10.1213/01.ANE.0000085301.87286.59.
- Background: PubMed 19039300Cohen E. Recommendations for airway control and difficult airway management in thoracic anesthesia and lung separation procedures. Are we ready for the challenge? Minerva Anestesiol. 2009 Jan-Feb;75(1-2):3-5. Epub 2008 Nov 28. No abstract available.
- Background: PubMed 20007992Brodsky JB. Lung separation and the difficult airway. Br J Anaesth. 2009 Dec;103 Suppl 1:i66-75. doi: 10.1093/bja/aep262.
- Background: PubMed 10512293Fortier G, St-Onge S, Bussieres J. Two other simple methods to protect the tracheal cuff of a double-lumen tube. Anesth Analg. 1999 Oct;89(4):1064. doi: 10.1097/00000539-199910000-00047. No abstract available.
- Background: PubMed 8910162Perlin DI, Hannallah MS. Double-lumen tube placement in a patient with a difficult airway. J Cardiothorac Vasc Anesth. 1996 Oct;10(6):787-8. doi: 10.1016/S1053-0770(96)80208-4. No abstract available.
- Background: PubMed 12826557Cooper RM. Use of a new videolaryngoscope (GlideScope) in the management of a difficult airway. Can J Anaesth. 2003 Jun-Jul;50(6):611-3. doi: 10.1007/BF03018651.
- Background: PubMed 18377671Rope TC, Loughnan BA, Vaughan DJ. Videolaryngoscopy--an answer to difficult laryngoscopy? Eur J Anaesthesiol. 2008 May;25(5):434-5. doi: 10.1017/S0265021507002931. No abstract available.
- Background: PubMed 17975233Turkstra TP, Harle CC, Armstrong KP, Armstrong PM, Cherry RA, Hoogstra J, Jones PM. The GlideScope-specific rigid stylet and standard malleable stylet are equally effective for GlideScope use. Can J Anaesth. 2007 Nov;54(11):891-6. doi: 10.1007/BF03026792.
- Background: PubMed 18310639Neustein SM. The GlideScope-specific rigid stylet to facilitate tracheal intubation with the Glidescope. Can J Anaesth. 2008 Mar;55(3):196-7; author reply 197. doi: 10.1007/BF03016103. No abstract available.
- Background: PubMed 19690253van Zundert A, Maassen R, Lee R, Willems R, Timmerman M, Siemonsma M, Buise M, Wiepking M. A Macintosh laryngoscope blade for videolaryngoscopy reduces stylet use in patients with normal airways. Anesth Analg. 2009 Sep;109(3):825-31. doi: 10.1213/ane.0b013e3181ae39db.
- Background: PubMed 19713258Maassen R, Lee R, Hermans B, Marcus M, van Zundert A. A comparison of three videolaryngoscopes: the Macintosh laryngoscope blade reduces, but does not replace, routine stylet use for intubation in morbidly obese patients. Anesth Analg. 2009 Nov;109(5):1560-5. doi: 10.1213/ANE.0b013e3181b7303a. Epub 2009 Aug 27.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean S Bussières, MD principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Double Lumen Tube Intubation, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Successfull Primary Placement of the Double Lumen Tube. (time frame: 1 hour (Post intubation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01308918, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2012.