Trial Outcomes & Findings for Efficiency of the King Vision Video Laryngoscope (NCT NCT02482870)

Last Updated: 2023-12-20

Results Overview

Endotracheal intubation attempt is defined as entrance of the endotracheal tube into the patient's mouth. Any major change in the alignment of the laryngoscope is defined as another intubation attempt. Successful endotracheal intubation is defined as the endotracheal cuff passing through the patient's vocal cords. Intubation success rate is defined as: 1 / \[the number of attempts\].

Recruitment status

COMPLETED

Study phase

Target enrollment

388 participants

Primary outcome timeframe

less than 24 hours

Results posted on

2023-12-20

Participant Flow

This study enrolled adult patients scheduled for general anesthesia with intubation in Recep Tayyip Erdogan University Education and Research Hospital. The last patient completed in July 2014.

None of the 388 patients enrolled between January 2014 and July 2014 were excluded from the trial.

Participant milestones

Participant milestones
Measure	Macintosh First, Then King Vision The patients has been intubated first with a Macintosh, then with a King Vision video laryngoscope.	King Vision First, Then Macintosh The patients has been intubated first with a King Vision video laryngoscope, then with a Macintosh laryngoscope.
Overall Study STARTED	186	202
Overall Study COMPLETED	186	202
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficiency of the King Vision Video Laryngoscope

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=388 Participants Each patient were intubated with both Macintosh and King Vision video laryngoscope sequentially. The order of the laryngoscopes was randomized by flipping a coin.
Age, Continuous	48.5 years n=93 Participants
Sex: Female, Male Female	158 Participants n=93 Participants
Sex: Female, Male Male	230 Participants n=93 Participants
Height, Continuous	171 cm n=93 Participants
Weight, Continuous	80 kg n=93 Participants
Body mass index, Continuous	26.9 kg/m^2 n=93 Participants
History of obstructive sleep apnea, Categorical 0 - No history of obstructive sleep apnea	292 Participants n=93 Participants
History of obstructive sleep apnea, Categorical 1 - History of obstructive sleep apnea	96 Participants n=93 Participants
History of snoring, Categorical 0 - No history of snoring	246 Participants n=93 Participants
History of snoring, Categorical 1 - History of snoring	142 Participants n=93 Participants
Mallampati class, Categorical 0 - Ability to see any part of the epiglottis	0 Participants n=93 Participants
Mallampati class, Categorical 1 - Soft palate, fauces, uvula, pillars visible	79 Participants n=93 Participants
Mallampati class, Categorical 2 - Soft palate, fauces, uvula visible	113 Participants n=93 Participants
Mallampati class, Categorical 3 - Soft palate, base of uvula visible	107 Participants n=93 Participants
Mallampati class, Categorical 4 - Soft palate not visible at all	89 Participants n=93 Participants
American Society of Anesthesiologists score, Categorical 1 - A normal healthy patient	192 Participants n=93 Participants
American Society of Anesthesiologists score, Categorical 2 - A patient with mild systemic disease	196 Participants n=93 Participants
Thyromental distance, Continuous	6.2 cm n=93 Participants
Sternomental distance, Continuous	10.9 cm n=93 Participants
Interincisor distance, Continuous	3.3 cm n=93 Participants

PRIMARY outcome

Timeframe: less than 24 hours

Outcome measures

Outcome measures
Measure	Macintosh n=388 Participants Using a Macintosh laryngoscope, first pass intubation success rate has been recorded.	King Vision Video Laryngoscope n=388 Participants Using a King Vision video laryngoscope, first pass intubation success rate has been recorded.
Intubation Success Rate 0 - Could not be intubated	22 participants	13 participants
Intubation Success Rate 1 - Successfully intubated	366 participants	375 participants

SECONDARY outcome

Timeframe: less than 24 hours

Successful endotracheal intubation is defined as the endotracheal cuff passing the patient's vocal cords. Time to intubation with each laryngoscope is recorded.

Outcome measures

Outcome measures
Measure	Macintosh n=388 Participants Using a Macintosh laryngoscope, first pass intubation success rate has been recorded.	King Vision Video Laryngoscope n=388 Participants Using a King Vision video laryngoscope, first pass intubation success rate has been recorded.
Intubation Time	6.6 seconds Interval 5.0 to 8.9	10.8 seconds Interval 6.7 to 17.4

SECONDARY outcome

Timeframe: less than 24 hours

Glottic view time (as defined when the laryngoscopist declared the best Cormack-Lehane score) with each laryngoscope is recorded. Cormack-Lehane score is obtained by directly assessing the distance between the base of the tongue and the roof of the mouth to predict how difficult an intubation will be. It consists of 4 grades: 1. full view of glottis (difficult intubation unlikely) 2. partial view of glottis (\~5% risk of difficult intubation) 3. partial view of epiglottis, none of glottis seen (\~90% risk of difficult intubation) 4. neither glottis nor epiglottis seen (difficult intubation very likely)

Outcome measures

Outcome measures
Measure	Macintosh n=388 Participants Using a Macintosh laryngoscope, first pass intubation success rate has been recorded.	King Vision Video Laryngoscope n=388 Participants Using a King Vision video laryngoscope, first pass intubation success rate has been recorded.
Glottic View Time	7.3 seconds Interval 5.8 to 8.8	7.9 seconds Interval 6.0 to 11.8

SECONDARY outcome

Timeframe: less than 24 hours

Best Cormack-Lehane score (as declared by the laryngoscopist) obtained with both laryngoscopes is recorded. Cormack-Lehane score is graded according to the following criteria (1 is best, and 4 is worst): 1. full view of glottis (difficult intubation unlikely) 2. partial view of glottis (\~5% risk of difficult intubation) 3. partial view of epiglottis, none of glottis seen (\~90% risk of difficult intubation) 4. neither glottis nor epiglottis seen (difficult intubation very likely)

Outcome measures

Outcome measures
Measure	Macintosh n=388 Participants Using a Macintosh laryngoscope, first pass intubation success rate has been recorded.	King Vision Video Laryngoscope n=388 Participants Using a King Vision video laryngoscope, first pass intubation success rate has been recorded.
Cormack-Lehane Score 1 - Most of the glottis is visible	149 participants	357 participants
Cormack-Lehane Score 2 - At most half of the glottis is seen	139 participants	31 participants
Cormack-Lehane Score 3 - Only the epiglottis is visible	93 participants	0 participants
Cormack-Lehane Score 4 - No laryngeal structures are visible	7 participants	0 participants

SECONDARY outcome

Timeframe: The participants' will be followed for the duration of hospital stay, an expected average of 2 days

Any complication related to the laryngoscopy and intubation, such as cut, bleeding, damage to the teeth, laryngospasm, bronchospasm, desaturation below 90%, is recorded.

Outcome measures

Outcome measures
Measure	Macintosh n=388 Participants Using a Macintosh laryngoscope, first pass intubation success rate has been recorded.	King Vision Video Laryngoscope n=388 Participants Using a King Vision video laryngoscope, first pass intubation success rate has been recorded.
Airway Complications 0 - No complication	384 participants	382 participants
Airway Complications 1 - Minor cuts on the lips	4 participants	6 participants

Adverse Events

King Vision First, Then Macintosh

Serious events: 0 serious events

Other events: 3 other events

Deaths: 6 deaths

Macintosh First, Then King Vision

Serious events: 0 serious events

Other events: 3 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	King Vision First, Then Macintosh n=202 participants at risk These patients had been intubated with a King Vision video laryngoscope first, and then with a Macintosh laryngoscope. Airway complications related to the laryngoscopy and intubation (cuts, bleeding, damage to the teeth, laryngospasm, bronchospasm, desaturation below 90%) had been recorded.	Macintosh First, Then King Vision n=186 participants at risk These patients had been intubated with a Macintosh laryngoscope first, and then with a King Vision video laryngoscope. Airway complications related to the laryngoscopy and intubation (cuts, bleeding, damage to the teeth, laryngospasm, bronchospasm, desaturation below 90%) had been recorded.
Respiratory, thoracic and mediastinal disorders Situation of "can't intubate, can't ventilate"	0.00% 0/202 • 6 months Patients were supervised and observed for adverse events during the period they spent in the operating room, and post anesthetic care unit, by the attending anesthesiologist and anesthesia technician.	0.00% 0/186 • 6 months Patients were supervised and observed for adverse events during the period they spent in the operating room, and post anesthetic care unit, by the attending anesthesiologist and anesthesia technician.
Respiratory, thoracic and mediastinal disorders Laryngospasm/Bronchospasm	0.00% 0/202 • 6 months Patients were supervised and observed for adverse events during the period they spent in the operating room, and post anesthetic care unit, by the attending anesthesiologist and anesthesia technician.	0.00% 0/186 • 6 months Patients were supervised and observed for adverse events during the period they spent in the operating room, and post anesthetic care unit, by the attending anesthesiologist and anesthesia technician.
Respiratory, thoracic and mediastinal disorders Desaturation below 90%	0.00% 0/202 • 6 months Patients were supervised and observed for adverse events during the period they spent in the operating room, and post anesthetic care unit, by the attending anesthesiologist and anesthesia technician.	0.00% 0/186 • 6 months Patients were supervised and observed for adverse events during the period they spent in the operating room, and post anesthetic care unit, by the attending anesthesiologist and anesthesia technician.

Other adverse events

Other adverse events
Measure	King Vision First, Then Macintosh n=202 participants at risk These patients had been intubated with a King Vision video laryngoscope first, and then with a Macintosh laryngoscope. Airway complications related to the laryngoscopy and intubation (cuts, bleeding, damage to the teeth, laryngospasm, bronchospasm, desaturation below 90%) had been recorded.	Macintosh First, Then King Vision n=186 participants at risk These patients had been intubated with a Macintosh laryngoscope first, and then with a King Vision video laryngoscope. Airway complications related to the laryngoscopy and intubation (cuts, bleeding, damage to the teeth, laryngospasm, bronchospasm, desaturation below 90%) had been recorded.
Skin and subcutaneous tissue disorders Cuts on lips	1.5% 3/202 • Number of events 3 • 6 months Patients were supervised and observed for adverse events during the period they spent in the operating room, and post anesthetic care unit, by the attending anesthesiologist and anesthesia technician.	1.6% 3/186 • Number of events 3 • 6 months Patients were supervised and observed for adverse events during the period they spent in the operating room, and post anesthetic care unit, by the attending anesthesiologist and anesthesia technician.
Surgical and medical procedures Dental damage	0.00% 0/202 • 6 months Patients were supervised and observed for adverse events during the period they spent in the operating room, and post anesthetic care unit, by the attending anesthesiologist and anesthesia technician.	0.00% 0/186 • 6 months Patients were supervised and observed for adverse events during the period they spent in the operating room, and post anesthetic care unit, by the attending anesthesiologist and anesthesia technician.
Skin and subcutaneous tissue disorders Sore throat	0.00% 0/202 • 6 months Patients were supervised and observed for adverse events during the period they spent in the operating room, and post anesthetic care unit, by the attending anesthesiologist and anesthesia technician.	0.00% 0/186 • 6 months Patients were supervised and observed for adverse events during the period they spent in the operating room, and post anesthetic care unit, by the attending anesthesiologist and anesthesia technician.

Additional Information

Dr. Başar Erdivanlı

Recep Tayyip Erdogan University School of Medicine

Phone: +904642130491

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place