Endotracheal Tube Placement Using McGrath MAC® Video Laryngoscope Versus Macintosh Laryngoscope

NCT03503279 | Withdrawn FDA Device

• 1 other identifier: 2017H0236
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims...

• To assess the difference in intubation difficulty scale (IDS) score following ETT placement using McGrath MAC® video laryngoscope versus conventional intubation with Macintosh laryngoscope for bariatric surgery patients
• To assess the difference in hemodynamic stimulation (airway manipulation) events in both groups
• To assess the overall difference of the duration (seconds) of ETT placement between both groups
• To assess the difference of the duration (seconds) of ETT placement during every attempt (maximum of three attempts) between both groups.
• To assess the difference of STOP BANG score between both groups
• To assess the number of intubation attempts between both groups

Conditions

Intubation

Outcome Measures

Primary Outcomes (1)

• Difference in intubation difficulty scale (IDS) score following ETT placement using McGrath MAC® video laryngoscope versus conventional intubation with Macintosh laryngoscope for bariatric surgery patients

  The Intubation Difficulty Scale (IDS) is a mixture of subjective and objective conditions that allows a qualitative and quantitative methodology to the progressive nature of the difficulty of intubation (easy=0, slightly difficult= 0\<IDS≤5, moderate to major difficult= 5\<IDS, impossible intubation= ∞). It could be used to asses intubating conditions and methods with the objective of determining the relative values predictive factors of intubation difficulty and of the techniques used to decrease such difficulties. It has seven parameters that are scored after an intubation: # of intubation attempts; # of alternative techniques used; a modified Cormack grade for glottic visualization; subjective impression of the lifting force needed during laryngoscopy; the need for external laryngeal pressure to optimize glottic exposure; and the position of the vocal cords.

  Through study completion, on average of 1 week

Secondary Outcomes (5)

• Difference in hemodynamic stimulation (airway manipulation) events in both groupsmanipulation in both groups

  within 5 minutes after orotracheal intubation

• Overall difference of the duration (seconds) of ETT placement between both groups

  The length of time between the date and time when the start of endotracheal tube descent maneuver until the date and time when the tube is considered well positioned in the trachea, assessed up to 10 minutes

• Difference of the duration (seconds) of ETT placement during every attempt (maximum of three attempts) between both groups.

  Procedure (The duration of intubation is defined as the time taken from the insertion of the blade beyond the incisors until the verification of the presence of three consecutive normal capnography wave forms.)

• Difference of STOP BANG score between both groups

  Baseline (Preoperative)

• Number of intubation attempts between both groups

  Procedure (Time starting at first attempt to successful attempt)

Study Arms (2)

Macintosh Laryngoscope

NO INTERVENTION

McGrath MAC® Video Laryngoscope

ACTIVE COMPARATOR

Device: McGrath MAC® Video Laryngoscope

Interventions

McGrath MAC® Video Laryngoscope DEVICE

McGrath MAC® Video Laryngoscope have been developed to secure the airway and improve the management of difficult intubation. McGrath MAC® is a self-contained VL with a single-use blade; its structure is similar to the ML, but without the channel that guides the tube and a mounted LCD screen on the handle that is connected to a miniature camera with a light source at the tip of the blade, allowing the clinicians to directly observe surrounding anatomical airway structures during a tracheal intubation

McGrath MAC® Video Laryngoscope

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients (male or female) admitted for elective bariatric surgery under general anesthesia with orotracheal intubation
• Age \> 18 years old
• American Society of Anesthesiologists (ASA) score 1-3
• Patients capable of consenting in English language

You may not qualify if:

• Potential or history of difficult airway (see pages 11 and 12)
• Past medical history of confirmed uncontrolled gastrointestinal diseases including delayed gastric emptying, dysphagia, or other gastrointestinal motility disorders that according to the investigator will not qualify for the study
• Patients with uncontrolled metabolic disorders (e.g., diabetes mellitus, chronic kidney disease) or conditions that according to the investigator will not qualify for the study
• Pregnant women
• Prisoners
• Surgery requiring patient positioning other than supine
• Other mental, physical, and medical conditions where subject participation is inadvisable according to the investigator judgment

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210, United States

Location

Study Officials

• Sergio Bergese

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Doctoral Scholar

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: April 19, 2018
• Study Start: January 1, 2021
• Primary Completion: February 2, 2021
• Study Completion: March 1, 2021
• Last Updated: June 1, 2020

Record last verified: 2020-05

Locations

US (1)