Optimal Head and Neck Position for Videolaryngoscopy

NCT03810937 | Unknown

• 1 other identifier: ANS004
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Airway Complication of Anesthesia

Outcome Measures

Primary Outcomes (1)

• optimal head position during videolaryngoscopy intubation

  the optimum head position during videolaryngoscopy intubation will be successful first pass tracheal intubation.

  intratracheal intubation procedure

Secondary Outcomes (1)

• best laryngeal exposure

  intratracheal intubation procedure

Study Arms (2)

Group sniffing (S)

ACTIVE COMPARATOR

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

Group Flat (F)

ACTIVE COMPARATOR

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

Interventions

head position OTHER

head positioning in sniffing or flat position

Group Flat (F); Group sniffing (S)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Fahad Specialist Hospital Dammam: lead

Study Sites (1)

King Fahad Specialist Hospital

Dammam, Eastern Province, 31444, Saudi Arabia

RECRUITING

MeSH Terms

Interventions

Head-Down Tilt

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• MUNIR H BAMADHAJ, MD

  King Fahad Specialist Hospital Dammam

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MUNIR H BAMADHAJ, MD

CONTACT

00966138442222; MUNIR.BAMDHAJ@KFSH.MED.SA

ZAKI M ALZAHER, MD

CONTACT

00966138442222; ZAKI.ALZAHIR@KFSH.MED.SA

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Analysis of the recorded videolaryngoscopic attempts will be performed later by a blinded researcher who was not involved with airway management.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomized in 2 groups: * Group sniffing (S): 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. * Group flat (F): same procedure will be done but starting from sniffing position and the patient will be intubated in flat position.

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: January 22, 2019
• Study Start: August 1, 2018
• Primary Completion: February 1, 2019
• Study Completion: March 1, 2019
• Last Updated: January 25, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)