IntubationNoLintNCT03277872
NoL, HR and MABP Responses to Tracheal Intubation Performed With MAC Blade Versus Glidescope
A study testing Laryngoscopy with GlideScope (GVL) Blade and Laryngoscopy with MacIntosh (MAC) Blade in people with Intubation and Nociceptive Pain, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
Trial summary
Prospective, randomized and controlled who will be conducted in Maisonneuve-Rosemont hospital and whose objectives are: To observe if the alterations of the NoL index and the standard monitoring (Mean Arterial Blood Pressure and Heart Rate) (using the variability of NoL index and standard monitoring, peak NoL index… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation, Nociceptive Pain, Anesthesia
- What is being tested?
- Laryngoscopy with GlideScope (GVL) Blade and Laryngoscopy with MacIntosh (MAC) Blade
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 5 Sep 2017to 2 Jul 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA status I or II
- Mallampati class I or II
- Patients > 18 years old
- Elective general, gynecological, neurological, orthopedic, plastic or urological surgery under general anesthesia
- Type of surgery that usually necessitate endotracheal intubation and controlled ventilation
- Non-inlusion Criteria:
Show all 22Show fewer
- Patient refusal
- History of psychiatric diseases or psychological problems (including mental retardation); inability to give consent; language barrier.
- Anticipated difficult airway (Mallampati class III and IV, thyromental distance < 6 cm, mouth opening < 3 cm, neck extension <80° and neck flexion <35°, inability to prognath, meaning bringing lower mandibular before the upper maxilla)
- Patient with history of neck rigidity or instability
- BMI > 30
- Patient with beard (because of recognized risk for difficult ventilation)
- Patient with history of oropharyngeal or tracheal surgery (excluding adenoidectomy, amygdalectomy and teeth removal)
- Severe coronary artery disease
- Serious cardiac arrhythmias (including atrial fibrillation)
- Use of β-blockers (all types)
- History of opioid or illicit drug substance abuse
- Chronic use of psychotropic and/or opioid drugs
- Allergy to remifentanil or propofol
- Pregnancy
- Contraindications to mask ventilation (GI tract obstruction, pregnancy, active GERD, non-fasting patients)
- Difficult mask ventilation (before randomization at the first laryngoscopy)
Who cannot join
- Unexpected difficult airway requesting excessive, possibly painful airway manipulations
- Requiring hemodynamic support with vasopressors or inotropes 5 minutes before first laryngoscopy to 3 minutes after insertion of ETT
Trial locations and contacts
1 site in 1 country.
Canada1 site
Hopital Maisonneuve Rosemont, CIUSSS de l'Est de l'Ile de Montreal
Montreal East, Quebec, H1T2M4
About this study
Official title: NoL Index, Heart Rate and Mean Arterial Blood Pressure Responses to Tracheal Intubation Performed With MacIntosh Blade Versus Glidescope
Prospective, randomized and controlled who will be conducted in Maisonneuve-Rosemont hospital and whose objectives are:
- To observe if the alterations of the NoL index and the standard monitoring (Mean Arterial Blood Pressure and Heart Rate) (using the variability of NoL index and standard monitoring, peak NoL index and peak standard monitoring values, and number of time passed over their respective threshold for nociceptive response) are more accentuated after laryngoscopy using the classical MAC blade versus single-use disposable blade of the Glidescope.
- To observe the nociceptive response (using the variability of NoL index and standard monitoring, peak NoL index and peak standard monitoring values, and number of time passed over their respective threshold for nociceptive response) related to the insertion of endotracheal tube between vocal cords during the intubation.
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.
Read the detailed description
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.
- Conditions
- Intubation, Nociceptive Pain, Anesthesia, Laryngoscopy
- Being tested
- Laryngoscopy with GlideScope (GVL) Blade, Laryngoscopy with MacIntosh (MAC) Blade
- Medical subject headings
- Nociceptive Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laryngoscopy with GlideScope (GVL) BladeDevice
- st Laryngoscopy with GVL Blade
- nd Laryngoscopy with MAC Blade
- rd Laryngoscopy and ETT insertion with either GVL or MAC Blade according to 2nd randomization
Laryngoscopy with MacIntosh (MAC) BladeDevice
- st Laryngoscopy with MAC Blade
- nd Laryngoscopy with GVL Blade
- rd Laryngoscopy and ETT insertion with either GVL or MAC Blade according to 2nd randomization
| Study group | Role | What they receive |
|---|---|---|
| GlideScope (GVL) Blade | Active comparator | 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. Receives: Device: Laryngoscopy with GlideScope (GVL) Blade |
| MacIntosh (MAC) Blade | Active comparator | 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. Receives: Device: Laryngoscopy with MacIntosh (MAC) Blade |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
Secondary outcomes (23)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study start5 Sep 2017
- Primary completion7 Nov 2017
- Study completion2 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this study, each patient will be exposed to three laryngoscopies; one with the single use blade for the GlideScope and without ETT; one with the Macintosh laryngoscopy and without ETT; and one with the ETT insertion (laryngoscopy done with either GlideScope or Macintosh according to second randomization). The order in which will be used either the GlideScope or the MAC blade for the first two laryngoscopies will be decided according to the first randomization. This will lead to 2 different groups for the first randomization process regarding our primary objective: * GVL / MAC-DL / GVL or MAC-DL+ETT, * MAC-DL / GVL / GVL or MAC-DL+ETT. The tool used for the third laryngoscopy will be decided according to a second randomization, necessary to one of our secondary objectives. Each patient will be its own control when comparing nociceptive response to different laryngoscopy/intubation tool (no need for control group).
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ciusss de L'Est de l'Île de Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- Verathon, Canadian Hospital Specialties Ltd
- Responsible party
- Principal investigator, Philippe Richebe, Ciusss de L'Est de l'Île de Montréal
- Investigators
- Philippe Richebe, MD, PhD, Principal investigator, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03277872
- Sponsor's protocol ID
- 2018-1144
- Acronym
- NoLint
- Status last verified
- Oct 2021
- First submitted
- 29 Aug 2017
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sbeghen V, Verdonck O, McDevitt J, Zaphiratos V, Brulotte V, Loubert C, Tanoubi I, Drolet P, Belanger ME, Fortier LP, Godin N, Guertin MC, Fortier A, Richebe P. A randomized controlled trial comparing nociception level (NOL) index, blood pressure, and heart rate responses to direct laryngoscopy versus videolaryngoscopy for intubation: the NOLint project. Can J Anaesth. 2021 Jun;68(6):855-867. doi: 10.1007/s12630-021-01936-0. Epub 2021 Mar 11.
PubMed 33709262
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NoL Index, Heart Rate and Mean Arterial Blood Pressure Responses to Tracheal Intubation Performed With MacIntosh Blade Versus Glidescope
- ClinicalTrials.gov ID
- NCT03277872
- Acronym / sponsor ID
- NoLint / 2018-1144
- Conditions
- Intubation, Nociceptive Pain, Anesthesia, Laryngoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ciusss de L'Est de l'Île de MontréalUniversity, hospital or other
- Collaborators
- Verathon, Canadian Hospital Specialties Ltd
- Study start
- 5 Sep 2017 (actual)
- Primary completion
- 7 Nov 2017 (actual)
- Study completion
- 2 Jul 2021 (actual)
- First posted
- 11 Sep 2017 (actual)
- 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.
Prospective, randomized and controlled who will be conducted in Maisonneuve-Rosemont hospital and whose objectives are:
- To observe if the alterations of the NoL index and the standard monitoring (Mean Arterial Blood Pressure and Heart Rate) (using the variability of NoL index and standard monitoring, peak NoL index and peak standard monitoring values, and number of time passed over their respective threshold for nociceptive response) are more accentuated after laryngoscopy using the classical MAC blade versus single-use disposable blade of the Glidescope.
- To observe the nociceptive response (using the variability of NoL index and standard monitoring, peak NoL index and peak standard monitoring values, and number of time passed over their respective threshold for nociceptive response) related to the insertion of endotracheal tube between vocal cords during the intubation.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In this study, each patient will be exposed to three laryngoscopies; one with the single use blade for the GlideScope and without ETT; one with the Macintosh laryngoscopy and without ETT; and one with the ETT insertion (laryngoscopy done with either GlideScope or Macintosh according to second randomization). The order in which will be used either the GlideScope or the MAC blade for the first two laryngoscopies will be decided according to the first randomization. This will lead to 2 different groups for the first randomization process regarding our primary objective: * GVL / MAC-DL / GVL or MAC-DL+ETT, * MAC-DL / GVL / GVL or MAC-DL+ETT. The tool used for the third laryngoscopy will be decided according to a second randomization, necessary to one of our secondary objectives. Each patient will be its own control when comparing nociceptive response to different laryngoscopy/intubation tool (no need for control group).
| Arm | Type | Receives |
|---|---|---|
| GlideScope (GVL) Blade | Active comparator | Device: Laryngoscopy with GlideScope (GVL) BladePatients 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. |
| MacIntosh (MAC) Blade | Active comparator | Device: Laryngoscopy with MacIntosh (MAC) BladePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- ASA status I or II
- Mallampati class I or II
- Patients > 18 years old
- Elective general, gynecological, neurological, orthopedic, plastic or urological surgery under general anesthesia
- Type of surgery that usually necessitate endotracheal intubation and controlled ventilation
Key exclusion criteria (2 listed)
- Unexpected difficult airway requesting excessive, possibly painful airway manipulations
- Requiring hemodynamic support with vasopressors or inotropes 5 minutes before first laryngoscopy to 3 minutes after insertion of ETT
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 |
|---|---|---|
| Laryngoscopy with GlideScope (GVL) Blade1. 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 | Device | GlideScope (GVL) Blade |
| Laryngoscopy with MacIntosh (MAC) Blade1. 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 | Device | MacIntosh (MAC) Blade |
Primary outcome
Delta NoL
Time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
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
23 secondary outcomes
Delta Heart Rate
Time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
Delta Mean Arterial Blood Pressure
Time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
Peak value of NoL
Time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
Peak value of Heart Rate
Time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
Peak value of Mean Arterial Blood Pressure
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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)
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
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
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
Time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
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 4 Oct 2021.
- Derived from this study: PubMed 33709262Sbeghen V, Verdonck O, McDevitt J, Zaphiratos V, Brulotte V, Loubert C, Tanoubi I, Drolet P, Belanger ME, Fortier LP, Godin N, Guertin MC, Fortier A, Richebe P. A randomized controlled trial comparing nociception level (NOL) index, blood pressure, and heart rate responses to direct laryngoscopy versus videolaryngoscopy for intubation: the NOLint project. Can J Anaesth. 2021 Jun;68(6):855-867. doi: 10.1007/s12630-021-01936-0. Epub 2021 Mar 11.
- Individual participant dataSharing planned: No
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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.
Philippe Richebe, MD, PhD principal investigator
Université de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laryngoscopy with GlideScope (GVL) Blade and Laryngoscopy with MacIntosh (MAC) Blade in people with Intubation and Nociceptive Pain, run by Ciusss de L'Est de l'Île de Montréal 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 22 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 4 Oct 2021. 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?
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?
Delta NoL (time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient). 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 NCT03277872, which also lists 1 linked publication.
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 4 Oct 2021.