Anesthesia Intubation ComplicationGlidescopeNCT01424605
The Comparison of Glidescope® and the Direct Laryngoscopy in the Insertion of the Double Lumen Endotracheal Tube
A study testing DLT intubation in people with Anesthesia Intubation Complication, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
Double-lumen bronchial tube (DLT) had been demonstrated to benefit for thoracic surgery and also played an important role to achieve one-lung ventilation (OLV) for exploring the surgical fields. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia Intubation Complication
- What is being tested?
- DLT intubation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2010to Dec 2010
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Anesthesiologists physical status I-III, ≧ 18 years of age, and needed double-lumen endotracheal tube (DLT) for thoracic surgery
Who cannot join
- increased risk for regurgitation and pulmonary aspiration, history of gastroesophageal reflux, and pregnancy
- a tracheostomy or prolonged ventilation on ICU was planned, patients were also excluded
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
department of anesthesia, Kaohsiung medical university memorial hospital
Kaohsiung, Taiwan, 807
About this study
Double-lumen bronchial tube (DLT) had been demonstrated to benefit for thoracic surgery and also played an important role to achieve one-lung ventilation (OLV) for exploring the surgical fields. However, compared with the single-lumen endotracheal tube (SLT), the DLT had larger OD (outer diameter), longer length, and was more complex in its structure. For avoiding oral tissue trauma and shortening the DLT intubating time, thus, an adequate and complete glottic viewing under laryngoscope was needed.
Over the past decade, several video-assisted laryngoscopes had been developed to facilitate the tracheal intubation in the difficult airway. Among these devices, the GlideScope® videolaryngoscope (GVL) (Verathon, Bothell, WA, USA) was a reusable video laryngoscope with a 60° curvature blade. A light source and a digital video camera were installed at the tip of the laryngoscope blade and the pictures of the glottis and the vocal cords were displayed on an LCD monitor. We could insert the endotracheal tube passing the vocal cords into the trachea more precisely and had less tissue damaging under the GVL's guidance.
Compared with direct MacIntosh laryngoscope, the GVL had been reported that it can decrease the intubation time and increase the successful rate of first intubation in normal and difficult airways. However, the efficacy of the GVL in intubating the DLT was unclear and had never been evaluated. Therefore, the aim of this study was to compare the intubation conditions, safety, and patient comfort between using the GVL and the direct Macintosh laryngoscope in a specific population of patients needed DLT intubation. Main outcome measures were intubation success rates and the time needed to intubate the DLT with the two devices.
Read the detailed description
The study protocol was approved by the Institutional Research Board of the Memorial Hospitals of Kaohsiung Medical University and all patients included in the study gave written informed consent. Sixty patients with American Society of Anesthesiologists physical status I-III, ≧ 18 years of age, and needed double-lumen endotracheal tube (DLT) for thoracic surgery were enrolled in this study. Exclusion criteria were increased risk for regurgitation and pulmonary aspiration, history of gastroesophageal reflux, and pregnancy. Furthermore, when a tracheostomy or prolonged ventilation on ICU was planned, patients were also excluded. All tracheal intubations in the study were performed by two experienced (> 10 year) Board Certified anesthesiologists who each had experience of at least 300 tracheal intubations with each device before starting the study.
After the patient had entered the operating room, standard monitoring including ECG, invasive blood pressure measurement on the radial artery and pulse oximetry were established. Patients were randomly assigned to direct MacIntosh laryngoscope group (Group M, n = 30) or GVL group (Group G, n = 30) by opening a sealed envelope after they had entered the operating theatre. Anesthesia was induced with propofol 2-3 mg.kg-1, fentanyl 2μg.kg-1, and rocuronium 0.6mg.Kg-1. After achieving adequate muscle relaxation and anesthetic depth, DLT intubation was performed with direct laryngoscope or GVL. The bronchial and the tracheal cuff of the DLT were lubricated with SURGILUBE® sterile, surgical lubricant (E. FOUGERA \& CO. Melville, New York, A division of Nycomed US Inc.) thinly before intubation.
Measurements The demographic characteristics of both groups included age (years), gender (female/male), weight (kg), height (cm), body mass index (BMI), and ASA classification were recorded. The airway characteristics included the modified Mallampati classification, mouth opening (active and passive), and the thyromental distance were also recorded. Patients were measured of thyromental distance and incisor gap on maximal opening of the mouth and grading of The modified Mallampati classification in the operative room by another anesthesiologist not involved in the study. Passive mouth opening was measured after induction of anesthesia. After pre-oxygenation with oxygen 100%, patients received thiamylal 5 mg.kg-1 and fentanyl 2μg.kg-1 for anesthesia induction and facilitated DLT intubation with rocuronium 0.8 mg.kg-1 and propofol 1.0 mg.kg-1.
The total time to calculate DLT insertion (T3) was separated into T1 and T2, respectively, defined as started after jaw opening when the GVL or the direct laryngoscope passed the patient's lips and stopped when three complete waves of end-tidal CO2 showed on the monitor of capnography and measured by an independent observer. T1 time interval was calculated from the jaw opening, placement of GVL or standard Macintosh laryngoscope, to the view of glottis opening. T2 time interval was calculated from intubator holding DLT to three complete waves of end-tidal CO2 showed on the monitor of capnography. The procedures to position of DLT were declared in brief as following: the distal 10-12cm of the DLT was curved to approximately 90°; a conventional laryngoscope in group M and a Glidescope in group G to assist position DLT into trachea [4]; the tip of the DLT bronchial lumen was passed through the vocal cords and advanced into the glottis; to remove stylet of DLT; 180° counterclockwise rotation to facilitate the insertion of the bronchial cuff and tracheal lumen past the vocal cords; an additional 90° clockwise rotation to fit the tube into left main bronchus [5]. Grading of laryngo-pharyngeal tissues viewed by intubator according to the Cormack and Lehane classification (grades I-IV) that defined as grade I- complete glottis visible, grade II- anterior glottis not seen, grade III- epiglottis seen, but not glottis, and grade IV- epiglottis not seen [6]. The intubator determined the grades of laryngeal viewing either by direct laryngoscope or by Glidescope® with video monitor. The backwards upwards rightwards pressure (BURP) maneuver to optimize the glottis view was also recorded and the pressure grading was defined as none, light, and heavy.
After the blade of laryngoscope or GlideScope® was removed, we examined blood coating on its surface. The oral cavity, pharynx and larynx for signs of lacerations or bleeding provoked by the intubation was also examined by another otolaryngologist 5 minutes later, who was not aware of the chosen technique to complete intubation.
Hemodynamic parameters were recorded in the operating theatre after starting standard monitoring. Measurement of hemodynamic parameters included of time interval of baseline, intubation and post-intubation 1, 3 and 5 min, respectively. Anesthesia was maintained with sevoflurane. At the end of surgery, patients were trained to breathe spontaneously. The DLT was removed when spontaneous ventilation reached a tidal volume of 8 ml/kg and the patient could respond to simple verbal commands. The patients were interviewed by an independent investigator to determine whether they were suffering from a sore throat or dysphagia the next day of post-operation. We quantified the degree of soreness of the throat and dysphagia by using a visual analogue scale ranging from 0 to 10, with VAS 0 being rated as 'none', 1-3 as 'mild', 4-6 as moderate' and 7-10 as 'severe'.
Assuming a likely difference in mean times to intubate of 10 s with a SD of 10 s, an a priori power analysis revealed a group size of n = 27 was needed to detect a difference with a power of 0.8 at α-level of 0.05. Statistical analysis was performed using the Mann-Whitney U-test for non-parametric and univariate ANOVA for parametric data. Duncan's post-hoc test was performed where appropriate. Hemodynamic data were analyzed with ANOVA for repeated measures. Data are expressed as mean (SD) where applicable or actual numbers. SPSS 16.0.1 software (Apache Software Foundation, Forest Hill, MD, USA) was used for all statistical analyses.
- Conditions
- Anesthesia Intubation Complication
- Being tested
- DLT intubation
- Keywords
- left-sided double lumen bronchial tube, GlideScope videolaryngoscope, direct laryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DLT intubationProcedure or surgery
Also called Intubation with GlideScope
Using a video-assisted laryngoscope to facilitate endotracheal tube intubation
| Study group | Role | What they receive |
|---|---|---|
| DLT intubation | Experimental | Not described Receives: Procedure: DLT intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Main outcome measure is the successful rate of the first intubation compared with the two devices
Measured: 12 month
Secondary outcomes (3)
The outcome measure is the time needed to inert the DLT compared with the two devices
Measured: 12 months
The outcome measure were the hemodynamic parameters (such as mean blood pressure, and heart rate) compared with the two devices.
Measured: 12 months
The outcome measure is the incidence of complications (such as sorethroat, oral bleeding, and hypoxemia) compared with the two devices.
Hypoxemia is defined as the SPO2 is below 90%.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2011 (estimated)
- Study startJan 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia Intubation ComplicationStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hung-Te Hsu (980393), Kaohsiung Medical University Chung-Ho Memorial Hospital
- Investigators
- Hung-Te Hsu, MD, Principal investigator, Department of anesthesia, Kaoshiung medical university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01424605
- Sponsor's protocol ID
- KMUH-IRB-980393
- Other IDs
- KMUH-IRB-980393
- Acronym
- Glidescope
- Status last verified
- Aug 2011
- First submitted
- 18 May 2011
- Last updated
- 29 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Glidescope® and the Direct Laryngoscopy in the Insertion of the Double Lumen Endotracheal Tube
- ClinicalTrials.gov ID
- NCT01424605
- Acronym / sponsor ID
- Glidescope / KMUH-IRB-980393
- Conditions
- Anesthesia Intubation Complication
- Keywords
- left-sided double lumen bronchial tube, GlideScope videolaryngoscope, direct laryngoscope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 29 Aug 2011 (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.
Double-lumen bronchial tube (DLT) had been demonstrated to benefit for thoracic surgery and also played an important role to achieve one-lung ventilation (OLV) for exploring the surgical fields. However, compared with the single-lumen endotracheal tube (SLT), the DLT had larger OD (outer diameter), longer length, and was more complex in its structure. For avoiding oral tissue trauma and shortening the DLT intubating time, thus, an adequate and complete glottic viewing under laryngoscope was needed.
Over the past decade, several video-assisted laryngoscopes had been developed to facilitate the tracheal intubation in the difficult airway. Among these devices, the GlideScope® videolaryngoscope (GVL) (Verathon, Bothell, WA, USA) was a reusable video laryngoscope with a 60° curvature blade. A light source and a digital video camera were installed at the tip of the laryngoscope blade and the pictures of the glottis and the vocal cords were displayed on an LCD monitor. We could insert the endotracheal tube passing the vocal cords into the trachea more precisely and had less tissue damaging under the GVL's guidance.
Compared with direct MacIntosh laryngoscope, the GVL had been reported that it can decrease the intubation time and increase the successful rate of first intubation in normal and difficult airways. However, the efficacy of the GVL in intubating the DLT was unclear and had never been evaluated. Therefore, the aim of this study was to compare the intubation conditions, safety, and patient comfort between using the GVL and the direct Macintosh laryngoscope in a specific population of patients needed DLT intubation. Main outcome measures were intubation success rates and the time needed to intubate the DLT with the two devices.
Detailed description
The study protocol was approved by the Institutional Research Board of the Memorial Hospitals of Kaohsiung Medical University and all patients included in the study gave written informed consent. Sixty patients with American Society of Anesthesiologists physical status I-III, ≧ 18 years of age, and needed double-lumen endotracheal tube (DLT) for thoracic surgery were enrolled in this study. Exclusion criteria were increased risk for regurgitation and pulmonary aspiration, history of gastroesophageal reflux, and pregnancy. Furthermore, when a tracheostomy or prolonged ventilation on ICU was planned, patients were also excluded. All tracheal intubations in the study were performed by two experienced (> 10 year) Board Certified anesthesiologists who each had experience of at least 300 tracheal intubations with each device before starting the study.
After the patient had entered the operating room, standard monitoring including ECG, invasive blood pressure measurement on the radial artery and pulse oximetry were established. Patients were randomly assigned to direct MacIntosh laryngoscope group (Group M, n = 30) or GVL group (Group G, n = 30) by opening a sealed envelope after they had entered the operating theatre. Anesthesia was induced with propofol 2-3 mg.kg-1, fentanyl 2μg.kg-1, and rocuronium 0.6mg.Kg-1. After achieving adequate muscle relaxation and anesthetic depth, DLT intubation was performed with direct laryngoscope or GVL. The bronchial and the tracheal cuff of the DLT were lubricated with SURGILUBE® sterile, surgical lubricant (E. FOUGERA \& CO. Melville, New York, A division of Nycomed US Inc.) thinly before intubation.
Measurements The demographic characteristics of both groups included age (years), gender (female/male), weight (kg), height (cm), body mass index (BMI), and ASA classification were recorded. The airway characteristics included the modified Mallampati classification, mouth opening (active and passive), and the thyromental distance were also recorded. Patients were measured of thyromental distance and incisor gap on maximal opening of the mouth and grading of The modified Mallampati classification in the operative room by another anesthesiologist not involved in the study. Passive mouth opening was measured after induction of anesthesia. After pre-oxygenation with oxygen 100%, patients received thiamylal 5 mg.kg-1 and fentanyl 2μg.kg-1 for anesthesia induction and facilitated DLT intubation with rocuronium 0.8 mg.kg-1 and propofol 1.0 mg.kg-1.
The total time to calculate DLT insertion (T3) was separated into T1 and T2, respectively, defined as started after jaw opening when the GVL or the direct laryngoscope passed the patient's lips and stopped when three complete waves of end-tidal CO2 showed on the monitor of capnography and measured by an independent observer. T1 time interval was calculated from the jaw opening, placement of GVL or standard Macintosh laryngoscope, to the view of glottis opening. T2 time interval was calculated from intubator holding DLT to three complete waves of end-tidal CO2 showed on the monitor of capnography. The procedures to position of DLT were declared in brief as following: the distal 10-12cm of the DLT was curved to approximately 90°; a conventional laryngoscope in group M and a Glidescope in group G to assist position DLT into trachea [4]; the tip of the DLT bronchial lumen was passed through the vocal cords and advanced into the glottis; to remove stylet of DLT; 180° counterclockwise rotation to facilitate the insertion of the bronchial cuff and tracheal lumen past the vocal cords; an additional 90° clockwise rotation to fit the tube into left main bronchus [5]. Grading of laryngo-pharyngeal tissues viewed by intubator according to the Cormack and Lehane classification (grades I-IV) that defined as grade I- complete glottis visible, grade II- anterior glottis not seen, grade III- epiglottis seen, but not glottis, and grade IV- epiglottis not seen [6]. The intubator determined the grades of laryngeal viewing either by direct laryngoscope or by Glidescope® with video monitor. The backwards upwards rightwards pressure (BURP) maneuver to optimize the glottis view was also recorded and the pressure grading was defined as none, light, and heavy.
After the blade of laryngoscope or GlideScope® was removed, we examined blood coating on its surface. The oral cavity, pharynx and larynx for signs of lacerations or bleeding provoked by the intubation was also examined by another otolaryngologist 5 minutes later, who was not aware of the chosen technique to complete intubation.
Hemodynamic parameters were recorded in the operating theatre after starting standard monitoring. Measurement of hemodynamic parameters included of time interval of baseline, intubation and post-intubation 1, 3 and 5 min, respectively. Anesthesia was maintained with sevoflurane. At the end of surgery, patients were trained to breathe spontaneously. The DLT was removed when spontaneous ventilation reached a tidal volume of 8 ml/kg and the patient could respond to simple verbal commands. The patients were interviewed by an independent investigator to determine whether they were suffering from a sore throat or dysphagia the next day of post-operation. We quantified the degree of soreness of the throat and dysphagia by using a visual analogue scale ranging from 0 to 10, with VAS 0 being rated as 'none', 1-3 as 'mild', 4-6 as moderate' and 7-10 as 'severe'.
Assuming a likely difference in mean times to intubate of 10 s with a SD of 10 s, an a priori power analysis revealed a group size of n = 27 was needed to detect a difference with a power of 0.8 at α-level of 0.05. Statistical analysis was performed using the Mann-Whitney U-test for non-parametric and univariate ANOVA for parametric data. Duncan's post-hoc test was performed where appropriate. Hemodynamic data were analyzed with ANOVA for repeated measures. Data are expressed as mean (SD) where applicable or actual numbers. SPSS 16.0.1 software (Apache Software Foundation, Forest Hill, MD, USA) was used for all statistical analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DLT intubation | Experimental | Procedure: DLT intubation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Anesthesiologists physical status I-III, ≧ 18 years of age, and needed double-lumen endotracheal tube (DLT) for thoracic surgery
Key exclusion criteria (2 listed)
- increased risk for regurgitation and pulmonary aspiration, history of gastroesophageal reflux, and pregnancy
- a tracheostomy or prolonged ventilation on ICU was planned, patients were also excluded
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 |
|---|---|---|
| DLT intubationAlso: Intubation with GlideScopeUsing a video-assisted laryngoscope to facilitate endotracheal tube intubation | Procedure or surgery | DLT intubation |
Primary outcome
Main outcome measure is the successful rate of the first intubation compared with the two devices
Time frame: 12 month
3 secondary outcomes
The outcome measure is the time needed to inert the DLT compared with the two devices
Time frame: 12 months
The outcome measure were the hemodynamic parameters (such as mean blood pressure, and heart rate) compared with the two devices.
Time frame: 12 months
The outcome measure is the incidence of complications (such as sorethroat, oral bleeding, and hypoxemia) compared with the two devices.
Time frame: 12 months
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 29 Aug 2011.
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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.
Hung-Te Hsu, MD principal investigator
Department of anesthesia, Kaoshiung medical university hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DLT intubation in people with Anesthesia Intubation Complication, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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 1 inclusion and 2 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 29 Aug 2011. 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 Taiwan. 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?
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?
Main outcome measure is the successful rate of the first intubation compared with the two devices (time frame: 12 month). 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 29 Aug 2011.