Comparison of 3 Direct Laryngoscopes for Tracheal Intubation in Patients Undergoing Lumbar Spine Surgery

NCT02955511 | Terminated Results FDA Device

• 1 other identifier: Pro00045198
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothesis The use of Macintosh blade sized #3.5 (vs Macintosh size #3) would reduce the time required to achieve successful tracheal intubation and improve the glottic view. Study objective The purpose of this research study is to compare 3 different laryngoscope blades (sizes: 3.5, 3.5 and 3) and see if the blades size 3.5 will reduce the time required to achieve successful tracheal intubation and improve the physician's view of the glottis compared to the standard direct laryngoscope using the blade size 3, in patients undergoing lumbar surgery. Primary end point: time to achieve successful tracheal intubation. Secondary end points: glottic view at intubation, number of intubation attempts and effectiveness of the integrated suction in the Inscope Direct Laryngoscope.

Conditions

Anesthesia; Airway

Outcome Measures

Primary Outcomes (3)

• Intubation Time (Using a Stopwatch)

  Intubation Time: It is the time taken to intubate: from the initial insertion of the laryngoscope blade to the placement of the tracheal tube (approximately 3 minutes). An intubation attempt: It is defined as the insertion of the laryngoscope blade into a patient's mouth, with the objective of inserting an endotracheal tube into the trachea.

  up to 3 minutes

• Glottis Visualization POGO Score

  The percentage of the glottis visualized (POGO) score It represents the percentage of glottic opening seen; the score ranges from 0% when none of the glottis is seen to 100% when the entire glottis, including the anterior commissure, is seen.

  During intubation procedure, up to 1 minute

• Time From the Insertion of the Laryngoscope Blade to Confirm w/ CO2 Waveform

  The time following the initial insertion of the laryngoscope blade into the mouth to confirm w/ CO2 waveform

  During intubation procedure, up to 3 minutes

Secondary Outcomes (2)

• Intubation Attempts

  3 minutes

• Glottis Visualization Using Cormack Lehane

  During intubation procedure, up to 1 minute

Study Arms (3)

Blade MAC size 3

ACTIVE COMPARATOR

Patient will be intubated using a: Direct Laryngoscope (DL) Mac size 3 (Sun-Med GreenLine®/D™ Macintosh)

Device: Blade MAC size 3

Blade MAC size 3.5

ACTIVE COMPARATOR

Patient will be intubated using a: DL-blade mac size 3.5 (Sun-Med Greenline®/D™ Macintosh)

Device: Blade MAC size 3.5

Inscope Blade size 3.5

EXPERIMENTAL

Patient will be intubated using a: Inscope DL-blade size 3.5

Device: Inscope Blade size 3.5

Interventions

Blade MAC size 3 DEVICE

Patient will be intubated using the DL- Blade MAC size 3

Blade MAC size 3

Blade MAC size 3.5 DEVICE

Patient will be intubated using the DL- Blade MAC size 3.5

Blade MAC size 3.5

Inscope Blade size 3.5 DEVICE

Patient will be intubated using the Inscope Blade size 3.5

Inscope Blade size 3.5

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing lumbar spine surgery procedures under general anesthesia
• Patients with a documented BMI of \<35
• Willingness and ability to sign an informed consent document
• years of age of either gender
• American Society of Anesthesiologists (ASA) physical status classification I - II or III

You may not qualify if:

• Patients who are deemed to be such a significant of an airway risk that they necessitate awake fiberoptic intubation or a difficult tracheal intubation is anticipated
• Patients with history of difficult intubation
• Patients with oxygen saturation less than 95% at room air
• Patients with history facial abnormalities, oral-pharyngeal cancer or reconstructive surgery
• Any pathologies of the mouth, pharynx or larynx, or the access to the airway is restricted
• Patients with Immobilized cervical spine, or history of cervical abnormalities
• Patients with a history of uncontrolled gastroesophageal reflux, hiatus hernia or diabetic gastroparesis
• Any coagulation disorder
• Pregnant patients
• Emergency surgeries
• Any other conditions or use of any medication which may interfere with the conduct of the Study

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Results Point of Contact

• Title: Dr. Ofelia Loani Elvir Lazo, Research Project Advisor
• Organization: Cedars Sinai Medical Center

ofelia.elvir-lazo@cshs.org

3104231682

Study Officials

• Roya Yumul, MD, PhD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: November 4, 2016
• Study Start: January 2, 2018
• Primary Completion: September 15, 2021
• Study Completion: September 15, 2021
• Last Updated: October 19, 2022
• Results First Posted: October 19, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)