NoL, HR and MABP Responses to Tracheal Intubation Performed With MAC Blade Versus Glidescope

NCT03277872 | Completed

• 1 other identifier: 2018-1144
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Intubation; Nociceptive Pain; Anesthesia; Laryngoscopy

Outcome Measures

Primary Outcomes (1)

• 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

  From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient

Secondary Outcomes (23)

• Delta Heart Rate

  From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient

• Delta Mean Arterial Blood Pressure

  From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient

• Peak value of NoL

  From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient

• Peak value of Heart Rate

  From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient

• Peak value of Mean Arterial Blood Pressure

  From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient

Study Arms (2)

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.

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.

Device: Laryngoscopy with MacIntosh (MAC) Blade

Interventions

Laryngoscopy with GlideScope (GVL) Blade DEVICE

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

GlideScope (GVL) Blade

Laryngoscopy with MacIntosh (MAC) Blade DEVICE

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

MacIntosh (MAC) Blade

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead
• Verathon: collaborator
• Canadian Hospital Specialties Ltd: collaborator

Study Sites (1)

Hopital Maisonneuve Rosemont, CIUSSS de l'Est de l'Ile de Montreal

Montreal East, Quebec, H1T2M4, Canada

Location

Related Publications (1)

• 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.

  PMID: 33709262 DERIVED

MeSH Terms

Conditions

Nociceptive Pain

Interventions

Laryngoscopy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Otorhinolaryngologic Surgical Procedures

Study Officials

• Philippe Richebe, MD, PhD

  Université de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: September 11, 2017
• Study Start: September 5, 2017
• Primary Completion: November 7, 2017
• Study Completion: July 2, 2021
• Last Updated: October 4, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)