Trial Outcomes & Findings for Determining the Depth of Endotracheal Tube Insertion (NCT NCT02158247)
NCT ID: NCT02158247
Last Updated: 2014-07-22
Results Overview
Airway length is defined the distance from medial incisor to carina. It is divided into four parts. It is medial incisor to mouth angle, mouth angle to epiglottis tip, epiglottis tip to vocal cords and vocal cords to carina.
Recruitment status
COMPLETED
Target enrollment
176 participants
Primary outcome timeframe
Endotracheal intubation time
Results posted on
2014-07-22
Participant Flow
Participant milestones
| Measure |
Tough and Read Group
This is a virtual experiment based on the anthropometry of the airway length. Conventional group : We defined the conventional group as patients who are intubated on the depth of 25cm for male and 23 cm fo female from the medial incisor virtually.
Touch and read group : Depth of intubation was determined on the measurement of the airway length of each patient. In touch and read group, the depth of intubation was determined by the sum of the length from the mouth angle to epiglottis tip, the length from the epiglottis tip to vocal cords and 8cm for the endotracheal tube #7.0. Length from the mouth angle to epiglottis tip is determined at the time of intubation with specially scaled endotracheal tube.
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|---|---|
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Overall Study
STARTED
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181
|
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Overall Study
COMPLETED
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176
|
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Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Tough and Read Group
This is a virtual experiment based on the anthropometry of the airway length. Conventional group : We defined the conventional group as patients who are intubated on the depth of 25cm for male and 23 cm fo female from the medial incisor virtually.
Touch and read group : Depth of intubation was determined on the measurement of the airway length of each patient. In touch and read group, the depth of intubation was determined by the sum of the length from the mouth angle to epiglottis tip, the length from the epiglottis tip to vocal cords and 8cm for the endotracheal tube #7.0. Length from the mouth angle to epiglottis tip is determined at the time of intubation with specially scaled endotracheal tube.
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|---|---|
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Overall Study
Invisible vocal cords
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5
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Baseline Characteristics
Determining the Depth of Endotracheal Tube Insertion
Baseline characteristics by cohort
| Measure |
Touch and Read Group(Male)
n=69 Participants
This is a virtual experiment based on the anthropometry of the airway length. We defined the conventional group as patients who are intubated on the depth of 25cm for male and 23 cm fo female from the medial incisor virtually.
Touch and read group : Depth of intubation was determined on the measurement of the airway length of each patient. In touch and read group, the depth of intubation was determined by the sum of the length from the mouth angle to epiglottis tip, the length from the epiglottis tip to vocal cords and 8cm for the endotracheal tube #7.0. Length from the mouth angle to epiglottis tip is determined at the time of intubation with specially scaled endotracheal tube.
|
Touch and Read Group(Female)
n=107 Participants
female
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Total
n=176 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=99 Participants
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0 Participants
n=107 Participants
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0 Participants
n=206 Participants
|
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Age, Categorical
Between 18 and 65 years
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62 Participants
n=99 Participants
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82 Participants
n=107 Participants
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144 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
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7 Participants
n=99 Participants
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25 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
107 Participants
n=107 Participants
|
107 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=99 Participants
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0 Participants
n=107 Participants
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69 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Endotracheal intubation timeAirway length is defined the distance from medial incisor to carina. It is divided into four parts. It is medial incisor to mouth angle, mouth angle to epiglottis tip, epiglottis tip to vocal cords and vocal cords to carina.
Outcome measures
| Measure |
Airway Length for Male
n=69 Participants
|
Airway Length of Female
n=107 Participants
|
|---|---|---|
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Comparison of Airway Length Between Male and Female
Medial incisor to mouth angle
|
0.9 Centimeters
Standard Deviation 0.5
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1.1 Centimeters
Standard Deviation 0.5
|
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Comparison of Airway Length Between Male and Female
Mouth angle to epiglottis tip
|
9.1 Centimeters
Standard Deviation 1.0
|
8.3 Centimeters
Standard Deviation 1.0
|
|
Comparison of Airway Length Between Male and Female
Epiglottis tip to vocal cords
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4.4 Centimeters
Standard Deviation 0.9
|
3.6 Centimeters
Standard Deviation 0.9
|
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Comparison of Airway Length Between Male and Female
Vocal cords to carina
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11.9 Centimeters
Standard Deviation 1.3
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11.2 Centimeters
Standard Deviation 1.2
|
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Comparison of Airway Length Between Male and Female
Medial incisor to carina
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26.4 Centimeters
Standard Deviation 1.9
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24.2 Centimeters
Standard Deviation 1.5
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PRIMARY outcome
Timeframe: Endotracheal intubation timeOutcome measures
| Measure |
Airway Length for Male
n=69 Participants
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Airway Length of Female
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|---|---|---|
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Airway Length vs Height in Male
Mouth angle to carina
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25.5 Centimeters
Standard Deviation 1.8
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—
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Airway Length vs Height in Male
Mouth angle to epiglottis tip
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9.1 Centimeters
Standard Deviation 1.0
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—
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Airway Length vs Height in Male
Epiglottis tip to vocal cords
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4.4 Centimeters
Standard Deviation 0.9
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—
|
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Airway Length vs Height in Male
Vocal cords to carina
|
11.9 Centimeters
Standard Deviation 1.3
|
—
|
|
Airway Length vs Height in Male
Male height
|
168 Centimeters
Standard Deviation 7.4
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—
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PRIMARY outcome
Timeframe: Endotracheal intubation timeOutcome measures
| Measure |
Airway Length for Male
n=107 Participants
|
Airway Length of Female
|
|---|---|---|
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Airway Length vs Height in Female
Mouth angle to carina
|
23.2 Centimeters
Standard Deviation 1.5
|
—
|
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Airway Length vs Height in Female
Mouth angle to epiglottis tip
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8.3 Centimeters
Standard Deviation 1.0
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—
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Airway Length vs Height in Female
Epglottis tip to vocal cords
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3.6 Centimeters
Standard Deviation 0.9
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—
|
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Airway Length vs Height in Female
Vocal cords to carina
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11.2 Centimeters
Standard Deviation 1.2
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—
|
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Airway Length vs Height in Female
Female height
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156.4 Centimeters
Standard Deviation 5.2
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—
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SECONDARY outcome
Timeframe: Endotracheal intubation timeNormal group is defined as the patients whose airway length from medial incisor to carina is below 25cm. Conventional method : depth of intubation is 23cm at the medial incisor for male. Touch and read method : depth of intubation is calculated as follow : length from mouth angle to epiglottis tip plus 12.5cm for male.
Outcome measures
| Measure |
Airway Length for Male
n=15 Participants
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Airway Length of Female
n=15 Participants
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|---|---|---|
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Comparison Between Conventional Method and Touch and Read Method for Risk Group of Male
Tube tip to carina
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0.7 Centimeters
Standard Deviation 1.4
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2.0 Centimeters
Standard Deviation 1.2
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Comparison Between Conventional Method and Touch and Read Method for Risk Group of Male
Vocal cords to cuff
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3.5 Centimeters
Standard Deviation 1.4
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2.3 Centimeters
Standard Deviation 1.1
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SECONDARY outcome
Timeframe: Endotracheal intubation timeNormal group is defined as the patients whose airway length from medial incisor to carina is over 25cm. Conventional method : depth of intubation is 23cm at the medial incisor for male. Touch and read method : depth of intubation is calculated as follow : length from mouth angle to epiglottis tip plus 12.5cm for male.
Outcome measures
| Measure |
Airway Length for Male
n=54 Participants
|
Airway Length of Female
n=54 Participants
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|---|---|---|
|
Comparison Between Conventional Method and Touch and Read Method for Normal Group of Male
Tube tip to carina
|
4.1 Centimeters
Standard Deviation 1.2
|
4.4 Centimeters
Standard Deviation 1.2
|
|
Comparison Between Conventional Method and Touch and Read Method for Normal Group of Male
Vocal cords to cuff
|
2.3 Centimeters
Standard Deviation 0.8
|
2.0 Centimeters
Standard Deviation 1.0
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SECONDARY outcome
Timeframe: Endotracheal intubation timeRisk group is defined as the patients whose airway length from medial incisor to carina is below 23cm. Conventional method : depth of intubation is 21cm at the medial incisor for female. Touch and read method : depth of intubation is calculated as follow : length from mouth angle to epiglottis tip plus 11.5cm for female.
Outcome measures
| Measure |
Airway Length for Male
n=24 Participants
|
Airway Length of Female
n=24 Participants
|
|---|---|---|
|
Comparison Between Conventional Method and Touch and Read Method for Risk Group of Female
Tube tip to carina
|
1.2 Centimeters
Standard Deviation 1.0
|
1.9 Centimeters
Standard Deviation 1.1
|
|
Comparison Between Conventional Method and Touch and Read Method for Risk Group of Female
Vocal cords to cuff
|
2.7 Centimeters
Standard Deviation 0.9
|
2.0 Centimeters
Standard Deviation 0.9
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SECONDARY outcome
Timeframe: Endotracheal intubation timeNormal group is defined as the patients whose airway length from medial incisor to carina is over 23cm. Conventional method : depth of intubation is 21cm at the medial incisor for female. Touch and read method : depth of intubation is calculated as follow : length from mouth angle to epiglottis tip plus 11.5cm for female.
Outcome measures
| Measure |
Airway Length for Male
n=83 Participants
|
Airway Length of Female
n=83 Participants
|
|---|---|---|
|
Comparison Between Conventional Method and Touch and Read Method for Normal Group of Female
Tube tip to carina
|
3.8 Centimeters
Standard Deviation 1.0
|
3.8 Centimeters
Standard Deviation 1.0
|
|
Comparison Between Conventional Method and Touch and Read Method for Normal Group of Female
Vocal cords to cuff
|
1.8 Centimeters
Standard Deviation 0.9
|
1.9 Centimeters
Standard Deviation 1.0
|
Adverse Events
Touch and Read Group(Male)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Touch and Read Group(Female)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Touch and Read Group(Male)
n=71 participants at risk
This is a virtual experiment based on the anthropometry of the airway length. We defined the conventional group as patients who are intubated on the depth of 25cm for male and 23 cm fo female from the medial incisor virtually.
Touch and read group : Depth of intubation was determined on the measurement of the airway length of each patient. In touch and read group, the depth of intubation was determined by the sum of the length from the mouth angle to epiglottis tip, the length from the epiglottis tip to vocal cords and 8cm for the endotracheal tube #7.0. Length from the mouth angle to epiglottis tip is determined at the time of intubation with specially scaled endotracheal tube.
|
Touch and Read Group(Female)
n=110 participants at risk
female
|
|---|---|---|
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Respiratory, thoracic and mediastinal disorders
Hypoxemia
|
0.00%
0/71
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0.00%
0/110
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Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place