Trial Outcomes & Findings for McGrath Videolaryngoscopy and Direct Laryngoscopy Rapid Sequence Intubation (NCT NCT05850052)

Last Updated: 2025-02-03

Results Overview

The visualization of the vocal cords, defined using the modified Cormack and Lehane classification: Grade I: Full view of the glottis (vocal cords are completely visible). Grade IIa: Partial view of the glottis (only the posterior portion of the glottis is visible). Grade IIb: Only the arytenoids or the posterior extremity of the vocal cords are visible (the anterior commissure is not seen). Grade III: Only the epiglottis is visible (the glottis is not visible). Grade IV: Neither the epiglottis nor the glottis is visible (only the soft palate is seen).

Recruitment status

COMPLETED

Study phase

Target enrollment

400 participants

Primary outcome timeframe

From the start time of intubation to time of the end of surgery, up to 12 hours.

Results posted on

2025-02-03

Participant Flow

Randomization data were missing for n = 6 patients.

Participant milestones

Participant milestones
Measure	McGrath Videolaryngoscope for Rapid Endotracheal Intubation The researchers will use the McGrath videolaryngoscope for rapid sequence endotracheal intubation. McGrath videolaryngoscope for rapid sequence endotracheal intubation: Visualize a patient's airway to aid placement of tracheal tube with ease.	Efficacy of Conventional Direct Laryngoscopy The researchers seeks to compare the efficacy of conventional direct laryngoscopy using a Macintosh blade, Conventional direct laryngoscopy using a Macintosh blade: Examine a patient's airway to aid placement of tracheal tube with ease.
Overall Study STARTED	193	201
Overall Study COMPLETED	193	201
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Gender data for one patient is missing in Direct laryngoscopy group

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: From the start time of intubation to time of the end of surgery, up to 12 hours.

Outcome measures

Outcome measures
Measure	McGrath Videolaryngoscope for Rapid Endotracheal Intubation n=193 Participants The researchers will use the McGrath videolaryngoscope for rapid sequence endotracheal intubation. McGrath videolaryngoscope for rapid sequence endotracheal intubation: Visualize a patient's airway to aid placement of tracheal tube with ease.	Efficacy of Conventional Direct Laryngoscopy n=201 Participants The researchers seeks to compare the efficacy of conventional direct laryngoscopy using a Macintosh blade, Conventional direct laryngoscopy using a Macintosh blade: Examine a patient's airway to aid placement of tracheal tube with ease.
Visualization of the Vocal Cords Grade I - Full view of the glottis	90 Participants	85 Participants
Visualization of the Vocal Cords Grade IIa - Partial view of the glottis	63 Participants	67 Participants
Visualization of the Vocal Cords Grade IIb - Only the arytenoids or the posterior extremity of the vocal cords are visible	26 Participants	28 Participants
Visualization of the Vocal Cords Grade III - Only the epiglottis is visible	10 Participants	17 Participants
Visualization of the Vocal Cords Grade IV - Neither the epiglottis nor the glottis is visible	4 Participants	4 Participants

SECONDARY outcome

Timeframe: From the start time of intubation to time of the end of surgery, up to 12 hours.

Population: N = 4 patients were missing the number of attempts in the McGrath Videolaryngoscope group. N = 3 patients were missing the number of attempts in the Direct Laryngoscopy group.

An intubation attempt was recorded once the endotracheal tube entered the oral cavity

Outcome measures

Outcome measures
Measure	McGrath Videolaryngoscope for Rapid Endotracheal Intubation n=189 Participants The researchers will use the McGrath videolaryngoscope for rapid sequence endotracheal intubation. McGrath videolaryngoscope for rapid sequence endotracheal intubation: Visualize a patient's airway to aid placement of tracheal tube with ease.	Efficacy of Conventional Direct Laryngoscopy n=198 Participants The researchers seeks to compare the efficacy of conventional direct laryngoscopy using a Macintosh blade, Conventional direct laryngoscopy using a Macintosh blade: Examine a patient's airway to aid placement of tracheal tube with ease.
Number of Participants With 1, 2, 3, and 4 Intubation Attempts 1 intubation attempt	167 Participants	176 Participants
Number of Participants With 1, 2, 3, and 4 Intubation Attempts 2 intubation attempts	21 Participants	21 Participants
Number of Participants With 1, 2, 3, and 4 Intubation Attempts 3 intubation attempts	0 Participants	1 Participants
Number of Participants With 1, 2, 3, and 4 Intubation Attempts 4 intubation attempts	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From the start time of intubation to time of the end of surgery, up to 12 hours.

Intubation was considered a failure if there was: (1) a failure to intubate after 3 attempts, (2) the need to switch intubators or intubation device, or (3) the need to stop study per anesthesiologist's discretion.

Outcome measures

Outcome measures
Measure	McGrath Videolaryngoscope for Rapid Endotracheal Intubation n=193 Participants The researchers will use the McGrath videolaryngoscope for rapid sequence endotracheal intubation. McGrath videolaryngoscope for rapid sequence endotracheal intubation: Visualize a patient's airway to aid placement of tracheal tube with ease.	Efficacy of Conventional Direct Laryngoscopy n=201 Participants The researchers seeks to compare the efficacy of conventional direct laryngoscopy using a Macintosh blade, Conventional direct laryngoscopy using a Macintosh blade: Examine a patient's airway to aid placement of tracheal tube with ease.
Intubation Failure.	3 Participants	1 Participants

Adverse Events

McGrath Videolaryngoscope for Rapid Endotracheal Intubation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Efficacy of Conventional Direct Laryngoscopy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

YanYan Han

Cleveland Clinic Foundation

Phone: 216-444-2250

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	McGrath Videolaryngoscope for Rapid Endotracheal Intubation n=193 Participants The researchers will use the McGrath videolaryngoscope for rapid sequence endotracheal intubation. McGrath videolaryngoscope for rapid sequence endotracheal intubation: Visualize a patient's airway to aid placement of tracheal tube with ease.	Efficacy of Conventional Direct Laryngoscopy n=201 Participants The researchers seeks to compare the efficacy of conventional direct laryngoscopy using a Macintosh blade, Conventional direct laryngoscopy using a Macintosh blade: Examine a patient's airway to aid placement of tracheal tube with ease.	Total n=394 Participants Total of all reporting groups
Age, Continuous	46 years n=193 Participants	46 years n=201 Participants	46 years n=394 Participants
Sex: Female, Male Female	119 Participants n=193 Participants • Gender data for one patient is missing in Direct laryngoscopy group	109 Participants n=200 Participants • Gender data for one patient is missing in Direct laryngoscopy group	228 Participants n=393 Participants • Gender data for one patient is missing in Direct laryngoscopy group
Sex: Female, Male Male	74 Participants n=193 Participants • Gender data for one patient is missing in Direct laryngoscopy group	91 Participants n=200 Participants • Gender data for one patient is missing in Direct laryngoscopy group	165 Participants n=393 Participants • Gender data for one patient is missing in Direct laryngoscopy group
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Study center Istanbul	96 participants n=193 Participants	104 participants n=201 Participants	200 participants n=394 Participants
Study center Konya	97 participants n=193 Participants	97 participants n=201 Participants	194 participants n=394 Participants
BMI	28 kg/m^2 n=193 Participants	28 kg/m^2 n=201 Participants	28 kg/m^2 n=394 Participants
History of difficult airway Yes	6 Participants n=193 Participants • This data for one patient is missing in Direct laryngoscopy group	7 Participants n=200 Participants • This data for one patient is missing in Direct laryngoscopy group	13 Participants n=393 Participants • This data for one patient is missing in Direct laryngoscopy group
History of difficult airway No	187 Participants n=193 Participants • This data for one patient is missing in Direct laryngoscopy group	193 Participants n=200 Participants • This data for one patient is missing in Direct laryngoscopy group	380 Participants n=393 Participants • This data for one patient is missing in Direct laryngoscopy group
Mallampati score I (Soft palate, uvula, pillars visible	59 Participants n=192 Participants • The Mallampati score is missing for 1 patient in the McGrath Videolaryngoscope group and for 5 patients in the direct laryngoscopy group	54 Participants n=196 Participants • The Mallampati score is missing for 1 patient in the McGrath Videolaryngoscope group and for 5 patients in the direct laryngoscopy group	113 Participants n=388 Participants • The Mallampati score is missing for 1 patient in the McGrath Videolaryngoscope group and for 5 patients in the direct laryngoscopy group
Mallampati score II (Soft palate, major part of uvula visible)	89 Participants n=192 Participants • The Mallampati score is missing for 1 patient in the McGrath Videolaryngoscope group and for 5 patients in the direct laryngoscopy group	104 Participants n=196 Participants • The Mallampati score is missing for 1 patient in the McGrath Videolaryngoscope group and for 5 patients in the direct laryngoscopy group	193 Participants n=388 Participants • The Mallampati score is missing for 1 patient in the McGrath Videolaryngoscope group and for 5 patients in the direct laryngoscopy group
Mallampati score III (Soft palate, base of uvula visible)	39 Participants n=192 Participants • The Mallampati score is missing for 1 patient in the McGrath Videolaryngoscope group and for 5 patients in the direct laryngoscopy group	35 Participants n=196 Participants • The Mallampati score is missing for 1 patient in the McGrath Videolaryngoscope group and for 5 patients in the direct laryngoscopy group	74 Participants n=388 Participants • The Mallampati score is missing for 1 patient in the McGrath Videolaryngoscope group and for 5 patients in the direct laryngoscopy group
Mallampati score IV (Only hard palate visible	5 Participants n=192 Participants • The Mallampati score is missing for 1 patient in the McGrath Videolaryngoscope group and for 5 patients in the direct laryngoscopy group	3 Participants n=196 Participants • The Mallampati score is missing for 1 patient in the McGrath Videolaryngoscope group and for 5 patients in the direct laryngoscopy group	8 Participants n=388 Participants • The Mallampati score is missing for 1 patient in the McGrath Videolaryngoscope group and for 5 patients in the direct laryngoscopy group
ASA physical status 1 (Healthy)	41 Participants n=193 Participants • This data for one patient is missing in Direct laryngoscopy group	39 Participants n=200 Participants • This data for one patient is missing in Direct laryngoscopy group	80 Participants n=393 Participants • This data for one patient is missing in Direct laryngoscopy group
ASA physical status 2 (Mild systemic illness)	124 Participants n=193 Participants • This data for one patient is missing in Direct laryngoscopy group	135 Participants n=200 Participants • This data for one patient is missing in Direct laryngoscopy group	259 Participants n=393 Participants • This data for one patient is missing in Direct laryngoscopy group
ASA physical status 3 (Severe systemic illness)	28 Participants n=193 Participants • This data for one patient is missing in Direct laryngoscopy group	26 Participants n=200 Participants • This data for one patient is missing in Direct laryngoscopy group	54 Participants n=393 Participants • This data for one patient is missing in Direct laryngoscopy group