Thoracic SurgeryNCT02305667
Videolaryngoscopes for Double Lumen Tube Intubations
A study testing Macintosh, Glidescope® and Airtraq® in people with Thoracic Surgery and Need for Double Lumen Tubes, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Thoracic Surgery, Need for Double Lumen Tubes
- What is being tested?
- Macintosh, Glidescope® and Airtraq®
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 133 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- May 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists' physical status II/III
- Elective thoracic procedures
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Fahd Hospital of the University
Khobar, Eastern Province, 31952
About this study
Official title: A Comparison of Three Videolaryngoscopes for Double-Lumen Tubes Intubation in Humans. A Randomized Controlled Study
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.
Read the detailed description
Several regional surveys among thoracic anesthesiologists showed that the double-lumen endobronchial tubes (DLT) is still the first choice for lung separation.[1-3] The introduction of videolaryngoscopes (VL) enables the use of the DLTs instead of a bronchial blockers for lung separation in patients with difficult airway.[4-5]
There are numerous VLs, including, stylets, channeled and traditional VLs. The GlideScope®-assisted DLT insertion (Verathon Inc., Bothell, WA, USA), has been associated with variable intubation durations according to the experience of the intubating operators, despite superior vocal cord views.[6-7] The channeled VL, like as the Airtraq® (Prodol Limited, Viscaya, Spain) and the standard non-channeled blade of the King Vision™ (KVL™) (King Systems, Indianapolis, IN, USA), may offer additional benefits for DLT intubation in patients with limited mouth opening or restricted neck movement, [8-10] in whom the use of traditional VL like as the Glidescope® could be difficult. This is because of the larger outer diameter, the distal curvature and the increased rigidity of the DLT.[11]
Of note, the longer intubation durations with the use of different VL-assisted DLT insertion could be shortened with building up the operator's experience.
Comparing the effects of the three studied VLs on the time to DLT intubation in humans has not yet been studied.
We hypothesize that time to successful DLT intubation using the channeled VL, namely, the Airtraq® and KVL™, will be shorter than with the Macintosh (MAC) laryngoscope and GlideScope® VL when used by non-expert anesthesiologists. We will compare the effects of the MAC, GlideScope®, Airtraq® and KVL™ on the time to DLT intubation, laryngoscopic view, ease of intubation, number of intubation attempts, and number of optimization maneuvers in patients undergoing thoracic procedures using DLTs for one-lung ventilation (OLV).
Standard monitoring, and bispectral index (BIS), or state and response entropy based depth of anesthesia, (GE Healthcare, Helsinki, Finland) will be applied to all patients. Neuromuscular blockade will be measured with a train of four stimulation (TOF) of the ulnar nerve. Invasive blood pressure monitoring will be achieved by cannulation of the radial artery. After preoxygenation, general anesthesia will be induced with propofol 1.5 to 3mg kg-1 and fentanyl 2-3 µg kg-1 or remifentanil 0.05-0.2 ug Kg-1 min-1, titrated to achieve a BIS value < 60 or a state entropy values of less than 50 and a difference between response and state entropy of less than 10. Rocuronium (0.6 mg kg-1) will be given to facilitate intubation with an appropriate sized left-sided DLT.
In all groups, during the insertion of the DLT, exercise caution to avoid damage to the tracheal cuff by the upper teeth during its passage through the mouth opening. After DLT intubation, the tracheal cuff will be inflated and ventilation of the lungs commenced. Then, the correct position of its tip will be confirmed with a fiberoptic bronchoscope.
The first intubation attempt will be considered a failure if the trachea is not successfully intubated within 150 s or if the peripheral oxygen saturation (SpO2) decreases by 5%. Following an initial tracheal intubation failure, the participants will be allowed to use any maneuver and device they would normally use to navigate the DLT into the trachea.
Demographic data will be recorded including grade, experience with the VLs, and previous DLT intubation experience with the VLs.
All data, with the exception of the difficulty of device use score, will be recorded by blinded investigators.
A pilot study showed that the mean time to DLT intubation using the GlideScope® VL was 72 seconds with a standard deviation of 45.2 seconds. An a priori power analysis indicated that a sample size of 32 participants was sufficiently large to detect a 50% difference in the time to DLT intubation, during the use of the channeled VL, a type-I error of 0.008 (0.05/6 possible comparisons) and a power of 90%. We will add more patients (10%) for a final sample size of 35 participants to compensate dropping out during the study.
Data will be tested for normality using Kolmogorov-Smirnov test. Categorical data will be analyzed using the Fisher's exact test. Repeated-measures analysis of variance (ANOVA) will be used for continuous parametric variables, and the differences will be corrected by the post hoc Bonferroni test. Kruskal-Wallis test will be used for nonparametric values, and post hoc pairwise comparisons will be performed using the Wilcoxon rank-sum t test Continuous data will be presented as mean (standard deviation, SD), ordinal data will be presented as median (inter-quartile range), and categorical data will be presented as number (%). A value of p< 0.05 will be considered to be statistically significant.
- Conditions
- Thoracic Surgery, Need for Double Lumen Tubes
- Being tested
- Macintosh, Glidescope®, Airtraq®, King Vision™
- Keywords
- Laryngoscope, Macintosh, Glidescope®, King Vision™, Airtraq®, intubation, double lumen tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MacintoshDevice
double lumen tube intubation using the Macintosh laryngoscope
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
Airtraq®Device
double lumen tube intubation using the Airtraq® videolaryngoscope.
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.
| Study group | Role | What they receive |
|---|---|---|
| Macintosh | Placebo comparator | Double lumen tube intubation using Macintosh laryngoscope Receives: Device: Macintosh |
| Glidescope® | Active comparator | Double lumen tube intubation using Glidescope® videolaryngoscope Receives: Device: Glidescope® |
| Airtraq® | Active comparator | Double lumen tube intubation using Airtraq® videolaryngoscope Receives: Device: Airtraq® |
| King Vision™ | Active comparator | Double lumen tube intubation using King Vision™ videolaryngoscope Receives: Device: King Vision™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).[
Measured: 3 minutes after laryngoscopy
Secondary outcomes (7)
best obtained glottis view during laryngoscopy
using Cormack and Lehane direct view or the 'video assisted view' seen on the video display screen
Measured: 30 sec after laryngosocopy
ease of endobronchial intubation
a visual analogue score (VAS) of ease of endobronchial intubation (0 for much of ease and 100 for extremely difficult)
Measured: 30 sec after laryngosocopy
number of optimization maneuvers
Measured: 150 sec after laryngosocopy
number of the 'backwards upwards rightwards pressure' (BURP) maneuver
Measured: 150 sec after laryngosocopy
failure rate for double lumen tube intubation
Measured: 150 sec after laryngosocopy
sore throat
throat using a VAS from 0, indicating 'none' to 10, 'severe' sore throat
Measured: 48 hours after surgery
hoarseness
hoarseness using numerical scale observed by the anesthesiologist [0: absent, 1: subjective, or 3: aphonic]
Measured: 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study startMay 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic SurgeryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed R El Tahan, MD, Principal investigator, Associate Professor at Anesthesiology DeptAlaa khidr, MD, Study director, Imam Abdulrahman Bin Faisal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02305667
- Sponsor's protocol ID
- ANE-2014-11-27
- Status last verified
- Jan 2017
- First submitted
- 27 Nov 2014
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Three Videolaryngoscopes for Double-Lumen Tubes Intubation in Humans. A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02305667
- Acronym / sponsor ID
- ANE-2014-11-27
- Conditions
- Thoracic Surgery, Need for Double Lumen Tubes
- Keywords
- Laryngoscope, Macintosh, Glidescope®, King Vision™, Airtraq®, intubation, double lumen tube
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Imam Abdulrahman Bin Faisal UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 2 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Several regional surveys among thoracic anesthesiologists showed that the double-lumen endobronchial tubes (DLT) is still the first choice for lung separation.[1-3] The introduction of videolaryngoscopes (VL) enables the use of the DLTs instead of a bronchial blockers for lung separation in patients with difficult airway.[4-5]
There are numerous VLs, including, stylets, channeled and traditional VLs. The GlideScope®-assisted DLT insertion (Verathon Inc., Bothell, WA, USA), has been associated with variable intubation durations according to the experience of the intubating operators, despite superior vocal cord views.[6-7] The channeled VL, like as the Airtraq® (Prodol Limited, Viscaya, Spain) and the standard non-channeled blade of the King Vision™ (KVL™) (King Systems, Indianapolis, IN, USA), may offer additional benefits for DLT intubation in patients with limited mouth opening or restricted neck movement, [8-10] in whom the use of traditional VL like as the Glidescope® could be difficult. This is because of the larger outer diameter, the distal curvature and the increased rigidity of the DLT.[11]
Of note, the longer intubation durations with the use of different VL-assisted DLT insertion could be shortened with building up the operator's experience.
Comparing the effects of the three studied VLs on the time to DLT intubation in humans has not yet been studied.
We hypothesize that time to successful DLT intubation using the channeled VL, namely, the Airtraq® and KVL™, will be shorter than with the Macintosh (MAC) laryngoscope and GlideScope® VL when used by non-expert anesthesiologists. We will compare the effects of the MAC, GlideScope®, Airtraq® and KVL™ on the time to DLT intubation, laryngoscopic view, ease of intubation, number of intubation attempts, and number of optimization maneuvers in patients undergoing thoracic procedures using DLTs for one-lung ventilation (OLV).
Standard monitoring, and bispectral index (BIS), or state and response entropy based depth of anesthesia, (GE Healthcare, Helsinki, Finland) will be applied to all patients. Neuromuscular blockade will be measured with a train of four stimulation (TOF) of the ulnar nerve. Invasive blood pressure monitoring will be achieved by cannulation of the radial artery. After preoxygenation, general anesthesia will be induced with propofol 1.5 to 3mg kg-1 and fentanyl 2-3 µg kg-1 or remifentanil 0.05-0.2 ug Kg-1 min-1, titrated to achieve a BIS value < 60 or a state entropy values of less than 50 and a difference between response and state entropy of less than 10. Rocuronium (0.6 mg kg-1) will be given to facilitate intubation with an appropriate sized left-sided DLT.
In all groups, during the insertion of the DLT, exercise caution to avoid damage to the tracheal cuff by the upper teeth during its passage through the mouth opening. After DLT intubation, the tracheal cuff will be inflated and ventilation of the lungs commenced. Then, the correct position of its tip will be confirmed with a fiberoptic bronchoscope.
The first intubation attempt will be considered a failure if the trachea is not successfully intubated within 150 s or if the peripheral oxygen saturation (SpO2) decreases by 5%. Following an initial tracheal intubation failure, the participants will be allowed to use any maneuver and device they would normally use to navigate the DLT into the trachea.
Demographic data will be recorded including grade, experience with the VLs, and previous DLT intubation experience with the VLs.
All data, with the exception of the difficulty of device use score, will be recorded by blinded investigators.
A pilot study showed that the mean time to DLT intubation using the GlideScope® VL was 72 seconds with a standard deviation of 45.2 seconds. An a priori power analysis indicated that a sample size of 32 participants was sufficiently large to detect a 50% difference in the time to DLT intubation, during the use of the channeled VL, a type-I error of 0.008 (0.05/6 possible comparisons) and a power of 90%. We will add more patients (10%) for a final sample size of 35 participants to compensate dropping out during the study.
Data will be tested for normality using Kolmogorov-Smirnov test. Categorical data will be analyzed using the Fisher's exact test. Repeated-measures analysis of variance (ANOVA) will be used for continuous parametric variables, and the differences will be corrected by the post hoc Bonferroni test. Kruskal-Wallis test will be used for nonparametric values, and post hoc pairwise comparisons will be performed using the Wilcoxon rank-sum t test Continuous data will be presented as mean (standard deviation, SD), ordinal data will be presented as median (inter-quartile range), and categorical data will be presented as number (%). A value of p< 0.05 will be considered to be statistically significant.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Macintosh | Placebo comparator | Device: MacintoshDouble lumen tube intubation using Macintosh laryngoscope |
| Glidescope® | Active comparator | Device: Glidescope®Double lumen tube intubation using Glidescope® videolaryngoscope |
| Airtraq® | Active comparator | Device: Airtraq®Double lumen tube intubation using Airtraq® videolaryngoscope |
| King Vision™ | Active comparator | Device: King Vision™Double lumen tube intubation using King Vision™ videolaryngoscope |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists' physical status II/III
- Elective thoracic procedures
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Macintoshdouble lumen tube intubation using the Macintosh laryngoscope | Device | Macintosh |
| Glidescope®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 | Device | Glidescope® |
| Airtraq®double lumen tube intubation using the Airtraq® videolaryngoscope. | Device | Airtraq® |
| King Vision™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. | Device | King Vision™ |
Primary outcome
Time to the duration of endobronchial intubation
Time frame: 3 minutes after laryngoscopy
defined as the time from when the laryngoscope entered between the patient's lips until successful DLT placement (regardless of the number of attempts).[
7 secondary outcomes
best obtained glottis view during laryngoscopy
Time frame: 30 sec after laryngosocopy
ease of endobronchial intubation
Time frame: 30 sec after laryngosocopy
number of optimization maneuvers
Time frame: 150 sec after laryngosocopy
number of the 'backwards upwards rightwards pressure' (BURP) maneuver
Time frame: 150 sec after laryngosocopy
failure rate for double lumen tube intubation
Time frame: 150 sec after laryngosocopy
sore throat
Time frame: 48 hours after surgery
hoarseness
Time frame: 48 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2017.
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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.
Mohamed R El Tahan, MD principal investigator
Associate Professor at Anesthesiology Dept
Alaa khidr, MD study director
Imam Abdulrahman Bin Faisal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Macintosh, Glidescope® and Airtraq® in people with Thoracic Surgery and Need for Double Lumen Tubes, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
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 12 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 24 Jan 2017. 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 Saudi Arabia. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to the duration of endobronchial intubation (time frame: 3 minutes after laryngoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jan 2017.