Ignite Creation Date:
2024-05-06 @ 10:30 AM
Last Modification Date:
2024-10-26 @ 12:31 PM
Study NCT ID:
NCT03277872
Status:
COMPLETED
Last Update Posted:
2021-10-04
First Post:
2017-08-29
Brief Title:
NoL HR and MABP Responses to Tracheal Intubation Performed With MAC Blade Versus Glidescope
Sponsor:
Ciusss de LEst de lÎle de Montréal
Organization:
Ciusss de LEst de lÎle de Montréal
Study Overview
Official Title:
NoL Index Heart Rate and Mean Arterial Blood Pressure Responses to Tracheal Intubation Performed With MacIntosh Blade Versus Glidescope
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NoLint
Brief 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 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
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 wasnt 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 propofolremifentanil 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
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 wasnt 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 propofolremifentanil 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None