Optimal Head and Neck Position for Videolaryngoscopy

Optimal Head and Neck Position for Videolaryngoscopy Intubation

The introduction of videolaryngoscopy constituted a revolution in airway management since it could provide better laryngeal exposure (indirect) in situations of difficult or impossible visualization by direct laryngoscopy. The use of Videolaryngoscopes, however, does not always guarantee adequate exposure or end up always in successful tracheal intubation. Failed tracheal intubation with videolaryngoscopy has been reported. We hypothesized that may be the failure was due to omitting some preparatory steps, including optimal head positioning, leading to a less than expected exposure and/or difficult or impossible intubation. There are no recommendations currently from the scientific organizations regarding the optimal head position when using a GlideScope and it is unknown currently whether head position can affect visualization or tracheal intubation attempts when using this device.

Study Overview

• Status: Unknown
• Conditions: Airway Complication of Anesthesia
• Intervention / Treatment: Other: head position

Detailed Description

• Multicentric,randomized, prospective and controlled study.
• After Institutional Review Board approval, signed written informed consents will be obtained from 165 adult patients with American Society of Anesthesiologists physical status 1-3 who are scheduled for elective surgery requiring endotracheal intubation.
• The following parameters will assessed and documented during the preoperative airway evaluation: BMI, mouth opening, thyromental distance, range of neck movement, and modified Mallampati classification. An 8cm non-compressible pillow.
• Patients will be randomized following coin toss into two groups depending on intubation position; Group Sniffing position(S) for obverse side and group flat position(F) for reverse side
• After premedication, American Society of Anesthesiologists' standard monitors will be applied, and preoxygenation for 3 to 5 minutes will be performed. After anesthesia induction and complete muscle relaxation as evidenced by loss of all evoked adductor pollicis responses to train of four stimulation of the ulnar nerve:
• Group sniffing (S): investigator will start by performing first videolaryngoscopy to find best view in flat position then the anesthesiologist will remove the Glidescope and the patient will be positioned in sniffing position using the pillow and another videolaryngoscopy will be attempted in sniffing position to find best view in this position and the patient will be intubated in this position.
• Group flat (F): same procedure will be done but starting from sniffing position and the patient will be intubated in flat position.
• The laryngoscopist will be asked not to use external laryngeal manipulation and to use the same lifting force throughout the study period. If these maneuvers deemed necessary for tracheal intubation (no visualization of vocal cords from full inflation to full deflation or the reverse, the laryngoscopist will be asked grade the view before applying the maneuver then use the required maneuver and record which intervention was needed and utilized.
• The estimated time to review theses different head elevation degrees is around 45 seconds.
• After preoxygenation technique we have a margin of 6 to 8 minutes of apnea without significant desaturation. Investigator will exclude also patients with high risk of desaturation (obesity and initial low saturation).
• The indirect laryngoscopic views will be graded using the same grading method used for direct laryngoscopy i.e. modified Cormack and Lehane. POGO score (percent of glottis opening viewed) will be also used to subcategorize subjects whose views lie between grade 1 and 3 C&L.

Analysis of the recorded videolaryngoscopic attempts will be performed later by a blinded researcher who was not involved with airway management.

• Study Type: Interventional
• Enrollment (Anticipated): 170
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MUNIR H BAMADHAJ, MD; Phone Number: 3993 00966138442222; Email: MUNIR.BAMDHAJ@KFSH.MED.SA
• Study Contact Backup: Name: ZAKI M ALZAHER, MD; Phone Number: 3939 00966138442222; Email: ZAKI.ALZAHIR@KFSH.MED.SA

Study Locations

• Saudi Arabia
  • Eastern Province
    • Dammam, Eastern Province, Saudi Arabia, 31444
      • Recruiting
      • King Fahad Specialist Hospital
      • Contact: AHED M ZAIDANE, MD; Phone Number: 3993 +966138442222; Email: AHED.ZEIDAN@KFSH.MED.SA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patients with American Society of Anesthesiologists physical status 1-3 who are scheduled for elective surgery requiring endotracheal intubation.

Exclusion Criteria:

• history of difficult intubation, poor dentition, gastroesophageal reflux disease ,initial low oxygen saturation, severe/morbid obesity (body mass index [BMI] greater than 35 kg/m2),neck deformities, atlano-axial subluxation or at risk of aspiration.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group sniffing (S); intervention: Head position changes : we will start by performing first videolaryngoscopy to find best view in flat position then the anesthesiologist will remove the Glidescope and the patient will be positioned in sniffing position using the pillow and another videolaryngoscopy will be attempted in sniffing position to find best view in this position and the patient will be intubated in this position.	Other: head position; head positioning in sniffing or flat position
Active Comparator: Group Flat (F); intervention: Head position changes same procedure will be done but starting from sniffing position and the patient will be intubated in flat position.	Other: head position; head positioning in sniffing or flat position

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
optimal head position during videolaryngoscopy intubation	the optimum head position during videolaryngoscopy intubation will be successful first pass tracheal intubation.	intratracheal intubation procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
best laryngeal exposure	the best laryngeal exposure (according to modified Cormack and Lehane classification) head position	intratracheal intubation procedure

Collaborators and Investigators

• Sponsor: King Fahad Specialist Hospital Dammam
• Investigators: Principal Investigator: MUNIR H BAMADHAJ, MD, King Fahad Specialist Hospital Dammam

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Anticipated): February 1, 2019
• Study Completion (Anticipated): March 1, 2019

Study Registration Dates

• First Submitted: January 18, 2019
• First Submitted That Met QC Criteria: January 18, 2019
• First Posted (Actual): January 22, 2019

Study Record Updates

• Last Update Posted (Actual): January 25, 2019
• Last Update Submitted That Met QC Criteria: January 23, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: ANS004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No