An interventional study of Laryngoscopy with GlideScope (GVL) Blade and Laryngoscopy with MacIntosh (MAC) Blade in Intubation, Nociceptive Pain and Anesthesia, sponsored by Ciusss de L'Est de l'Île de Montréal. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-04.
Sponsored by Ciusss de L'Est de l'Île de Montréal · Not applicable, Interventional, and Other
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Prospective, randomized and controlled who will be conducted in Maisonneuve-Rosemont hospital and whose objectives are:
Study plans to enroll 50 adult patients scheduled to undergo either general, gynecological, neurological, orthopedic, plastic or urological surgery under general anesthesia and who necessitate endotracheal intubation.
The purpose of this prospective pragmatic study is to evaluate the changes in NoL index, Heart Rate (HR) and Mean Arterial Blood Pressure (MABP) following the painful stimulus that represents laryngoscopy and intubation performed using either the single use blade of the Glidescope (group GVL) or the classically used MAC blade (group MAC). Calculation will be using the variations of NoL, HR and MABP, the peak values of these 3 parameters, and also the area above the curve of each parameter for 3 minutes (above the mean pre-stimulus values) and the amount of time (out of 3 minutes post-stimulus) those 3 parameters will be significantly higher than their respective pre-intubation mean thresholds.
In this prospective, randomized and controlled study, each patient will normally enter the operating room on the day of his surgery. All the normal monitors are installed, along with the NoL monitor. Pre-oxygenation (with 100% 02) is then started. While the patient is doing the pre-oxygenation, MABP, HR and NoL index measures are gathered to establish a baseline for each patient.
Once pre-oxygenation is over, induction with xylocaïne, propofol, remifentanil and rocuronium is given (according to patients' ideal weight). The end of the remifentanil bolus will correspond to the time 0 of our study. To be sure our patients are sleeping and on the same level of anesthetic medication during our study, perfusions of propofol and remifentanil will be administred until tracheal intubation and inhaled anesthetic gaz given. When the patient is asleep and apneic, a Guedel device (chosen according to patient weight and height) is inserted in the mouth, as in usual practice, to ease the manual ventilation until the laryngoscopy. The patient is then ventilated with a face mask. After 5 minutes, the first laryngoscopy is performed (either with GlideScope blade or MAC blade according to randomization). Once a Cormack-Lehane grade I or II is obtained, the movement is ended, and the patient is ventilated again for 4 minutes with the Guedel. If the procedure takes more than 30 seconds to perform (if no view of grade I or II is seen before 30 seconds), the laryngoscopy is considered difficult and the patient will be excluded from the study. At T9 (9 minutes after T0), the second laryngoscopy is done (either with the MacIntosh blade or the GVL blade - the tool used for the second laryngoscopy will always be the one that wasn't used at the first laryngoscopy). The size of the MacIntosh blade (MAC 3 or 4) or the disposable blade for GVL is decided according to the patient size (height and weight). At the second laryngoscopy, the endotracheal tube is still not inserted, only the procedure of laryngoscopy is done, so that we can evaluate the hemodynamic and the NoL index responses related only to the type of device used for laryngoscopy. Then, the operator replaces the Guedel and ventilates the patient with a facemask (100% O2) for 4 more minutes, without stimulating the patient otherwise. At T13 (13 minutes after T0), the third laryngoscopy will be performed (either with the single-use blade for GlideScope or the MacIntosh blade - according to randomization). This time, the ETT is inserted (size 7 or 8, depending on the size and sex of the patient). After ETT insertion, the patient is then ventilated with the anesthesia machine and the perfusions of propofol/remifentanil is discontinued.
Monitors will record HR, MABP and NoL index until 3 minutes after the ETT insertion (end of the study). All the data will be electronically registered every 5 seconds and exported in an anonymous manner for each patient into an excel file at the end of the study.
In this study, each patient is exposed to three laryngoscopies; one with the single use blade for the GlideScope, one with the Macintosh laryngoscopy and one with the ETT insertion (laryngoscopy done with either GlideScope or Macintosh according to randomization). Hence, each patient will be its own control. It will then be more reliable to compare the differences in nociceptive response according to the tool used for laryngoscopy.
96 studies on the registry are indexed under Nociceptive Pain; 18 are open to participants now.
This study's enrollment of 50 is below the median of 61 across 62 interventional studies indexed under Nociceptive Pain.
Browse Nociceptive Pain studies →Ciusss de L'Est de l'Île de Montréal is the lead sponsor of 90 studies on the registry; 32 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Non-inlusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in this arm will have the first laryngoscopy performed with the GlideScope (GVL) blade and the second one with the MacIntosh blade. The tool used for the third laryngoscopy, followed by intubation, (either GlideScope or MAC blade) will be decided according to a second randomization, necessary to one of our secondary objectives.
Device: Laryngoscopy with GlideScope (GVL) Blade
Patients in this arm will have the first laryngoscopy performed with the MacIntosh (MAC) blade and the second one with the GlideScope blade. The tool used for the third laryngoscopy, followed by intubation, (either GlideScope or MAC blade) will be decided according to a second randomization, necessary to one of our secondary objectives.
Device: Laryngoscopy with MacIntosh (MAC) Blade
1. st Laryngoscopy with GVL Blade 2. nd Laryngoscopy with MAC Blade 3. rd Laryngoscopy and ETT insertion with either GVL or MAC Blade according to 2nd randomization
1. st Laryngoscopy with MAC Blade 2. nd Laryngoscopy with GVL Blade 3. rd Laryngoscopy and ETT insertion with either GVL or MAC Blade according to 2nd randomization
Delta NoL
To compare the variation of NoL (delta NoL) after laryngoscopy using the single use blade for Glidescope (GVL) versus MAC blade (MAC) in anesthetized patients
Time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
Delta Heart Rate
To compare the variation of the standard hemodynamic parameter after laryngoscopy using the single use blade for Glidescope (GVL) versus MAC blade (MAC) in anesthetized patients
Time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
Delta Mean Arterial Blood Pressure
To compare the variation of the standard hemodynamic parameter after laryngoscopy using the single use blade for Glidescope (GVL) versus MAC blade (MAC) in anesthetized patients
Time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
Peak value of NoL
To compare the peak value of NoL after laryngoscopy in the GVL group versus the MAC group
Time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
Peak value of Heart Rate
To compare the peak value of standard hemodynamic parameter after laryngoscopy in the GVL group versus the MAC group
Time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
Peak value of Mean Arterial Blood Pressure
To compare the peak value of standard hemodynamic parameter after laryngoscopy in the GVL group versus the MAC group
Time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
Amount of time (in seconds) Mean Arterial Blood Pressure is over its baseline value after laryngoscopy stimulus
To compare the amount of time (in seconds) the MABP will spend over its respective mean pre-stimulus value after laryngoscopy with GVL versus MAC
Time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
Amount of time (in seconds) NoL, is over its baseline value after laryngoscopy stimulus
To compare the amount of time (in seconds) the NoL will spend over its respective mean pre-stimulus values after laryngoscopy with GVL versus MAC
Time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
Amount of time (in seconds) Heart Rate is over its baseline value after laryngoscopy stimulus
To compare the amount of time (in seconds) the HR will spend over its respective mean pre-stimulus value after laryngoscopy with GVL versus MAC
Time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
Area Under the Curve for NoL for GVL versus MAC blade
To compare the area under the curve between GVL versus MAC-Dl laryngoscopy that NoL spends above its baseline value and calculated for the 3 minutes after the stimulus
Time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
Area Under the Curve for Heart Rate for GVL versus MAC blade
To compare the area under the curve between GVL versus MAC-Dl laryngoscopy that HR spends above its baseline value and calculated for the 3 minutes after the stimulus
Time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
Area Under the Curve for Mean Arterial Blood Pressure for GVL versus MAC blade
To compare the area under the curve between GVL versus MAC-Dl laryngoscopy that MABP spends above its baseline value and calculated for the 3 minutes after the stimulus
Time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
Variation of NoL for laryngoscopy versus laryngoscopy + endotracheal intubation
To compare the variation of NoL after the laryngoscopy alone versus laryngoscopy + endotracheal tube (ETT) insertion in the GVL and the Mac group
Time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
Variation of HR for laryngoscopy versus laryngoscopy + endotracheal intubation
To compare the variation of HR after the laryngoscopy versus laryngoscopy + endotracheal tube (ETT) insertion in the GVL and the Mac group
Time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
Variation of MABP for laryngoscopy versus laryngoscopy + endotracheal intubation
To compare the variation of MABP after the laryngoscopy versus laryngoscopy + endotracheal tube (ETT) insertion in the GVL and the Mac group
Time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
Peak value of NoL for laryngoscopy versus laryngoscopy + endotracheal intubation
To compare the peak value of NoL after the laryngoscopy + endotracheal tube (ETT) insertion in the GVL and the Mac group
Time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
Peak value of HR for laryngoscopy versus laryngoscopy + endotracheal intubation
To compare the peak value of HR after the laryngoscopy + endotracheal tube (ETT) insertion in the GVL and the Mac group
Time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
Peak value of MABP for laryngoscopy versus laryngoscopy + endotracheal intubation
To compare the peak value of MABP after the laryngoscopy + endotracheal tube (ETT) insertion in the GVL and the Mac group
Time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
Area Under the Curve of NoL for laryngoscopy versus laryngoscopy + endotracheal intubation
To compare the AUC of NoL after the laryngoscopy + endotracheal tube (ETT) insertion in the GVL and the Mac group
Time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
Area Under the Curve of HR for laryngoscopy versus laryngoscopy + endotracheal intubation
To compare the AUC of HR after the laryngoscopy + endotracheal tube (ETT) insertion in the GVL and the Mac group
Time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
Area Under the Curve of MABP for laryngoscopy versus laryngoscopy + endotracheal intubation (with both devices)
To compare the AUC of MABP after the laryngoscopy + endotracheal tube (ETT) insertion in the GVL and the Mac group
Time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
Delta NoL analyzed according to order of randomization to see if this order influences its response
To compare the influence of the order of the tool used for laryngoscopies with the variation of NoL, after laryngoscopy using the single use blade for Glidescope (GVL) and MAC blade (MAC) in anesthetized patients
Time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
Delta Heart Rate analyzed according to order of randomization to see if this order influences its response
To compare the influence of the order of the tool used for laryngoscopies with the variation of HR, after laryngoscopy using the single use blade for Glidescope (GVL) and MAC blade (MAC) in anesthetized patients
Time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
Delta Mean Arterial Blood Pressure analyzed according to order of randomization to see if this order influences its response
To compare the influence of the order of the tool used for laryngoscopies with the variation of MABP, after laryngoscopy using the single use blade for Glidescope (GVL) and MAC blade (MAC) in anesthetized patients
Time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
Plan to share: No
Ran from Sep 2017 to primary completion in Nov 2017, 2 months.
Of 37 non-industry interventional studies with no phase under Nociceptive Pain, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 32. This study's 2 months is below that.
Counting every sponsor, half of 42 studies reached it within 8 months; a quarter within 3 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Ciusss de L'Est de l'Île de Montréal