Cholecystitis, Stomach Cancer
Conditions
Keywords
intubation, stylet, videolaryngoscope
Brief summary
The GlideScope® videolaryngoscope usually visualize glottis better than the conventional laryngoscope. Under the visualization of glottis by GlideScope®, the insertion of endotracheal tube, however, is challenging. The goal of this study was to determine which of two stylet (70° vs 90°) was better, as determined by time to intubation.
Interventions
PROCEDUREGlidescope guided intubation
DEVICEGlideScope®
Sponsors
Keimyung University Dongsan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients requiring endotracheal intubation for general anesthesia
Exclusion criteria
* Difficult airway * Rapid sequence induction * Recent sore throat * Fragile teeth * Contraindication for videolaryngoscope * Head and neck surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Intubation | Intraoperative intubation | Time from the insertion of the Glidescope blade to the measurement of end tidal CO2 (\>30 mmHg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difficulty of Intubation Measured Using Visual Analogue Scale | Intraoperative intubation | Difficulty of intubation will be measured using visual analogue scale (0:easiest, 100:most difficult). |
| Number of Participants for Whom External Laryngeal Manipulation Was Necessary | Intraoperative intubation | External laryngeal manipulation is defined as the compression of neck for the facilitation of laryngeal view. Number of participants for whom external laryngeal manipulation was necessary will be measured. |
| Cormack-Lehan Grade | Intraoperative intubation | The grade of Cormack-Lehan was assessed as I/II/III/IV (I: Full view of glottis, II: Partial view of glottis, III: Only epiglottis seen, none of glottis seen, IV: Neither glottis nor epiglottis seen). Grade I was considered better outcomes. |
| Mallampati Grade | Intraoperative anesthetic induction | The Mallapati grade was assessed as I/II/III/IV (I: Soft palate, uvula, fauces, pillars visible, II: Soft palate, uvula, fauces visible, III: Soft palate, base of uvula visible, IV: Only hard palate visible). Grade I was considered better outcomes. |
| Success Rate of Intubation | Intraoperative intubation | The number of patients in which the intubation was successful at the first time. |
| Postoperative Sore Throat Measured Using Visual Analogue Scale | at 1, 24 hr postoperatively | Postoperative sore throat will be measured using visual analogue scale (0:no pain, 100: worst pain imaginable) |
| Mean Blood Pressure | Intraoperative intubation | Mean blood pressure is measured before and 2 min after intubation. |
| Heart Rate | Intraoperative intubation | Heart rates are measured before and 2 min after intubation. |
| Airway Injury | Intraoperative intubation | Larynx injury is assessed. |
| Thyromental Distance | Intraoperative anesthetic induction | The thyromental distance was measured. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 90 Degree The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.
Glidescope guided intubation
GlideScope® | 78 |
| 70 Degree The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.
Glidescope guided intubation
GlideScope® | 79 |
| Total | 157 |
Baseline characteristics
| Characteristic | 70 Degree | 90 Degree | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 79 Participants | 78 Participants | 157 Participants |
| Age, Continuous | 57 years STANDARD_DEVIATION 16 | 58 years STANDARD_DEVIATION 13 | 58 years STANDARD_DEVIATION 14 |
| Region of Enrollment Korea, Republic of | 79 participants | 78 participants | 157 participants |
| Sex/Gender, Customized Female | 33 participants | 37 participants | 70 participants |
| Sex/Gender, Customized Male | 46 participants | 41 participants | 87 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 78 | 0 / 79 |
| other Total, other adverse events | 0 / 78 | 0 / 79 |
| serious Total, serious adverse events | 0 / 78 | 0 / 79 |
Outcome results
Primary
Time to Intubation
Time from the insertion of the Glidescope blade to the measurement of end tidal CO2 (\>30 mmHg)
Time frame: Intraoperative intubation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 90 Degree | Time to Intubation | 47.2 sec | Standard Deviation 35.8 |
| 70 Degree | Time to Intubation | 31.0 sec | Standard Deviation 17.5 |
Secondary
Airway Injury
Larynx injury is assessed.
Time frame: Intraoperative intubation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 90 Degree | Airway Injury | 5 Participants |
| 70 Degree | Airway Injury | 0 Participants |
Secondary
Cormack-Lehan Grade
The grade of Cormack-Lehan was assessed as I/II/III/IV (I: Full view of glottis, II: Partial view of glottis, III: Only epiglottis seen, none of glottis seen, IV: Neither glottis nor epiglottis seen). Grade I was considered better outcomes.
Time frame: Intraoperative intubation
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 90 Degree | Cormack-Lehan Grade | I | 70 Participants |
| 90 Degree | Cormack-Lehan Grade | II | 7 Participants |
| 90 Degree | Cormack-Lehan Grade | III | 1 Participants |
| 90 Degree | Cormack-Lehan Grade | IV | 0 Participants |
| 70 Degree | Cormack-Lehan Grade | IV | 0 Participants |
| 70 Degree | Cormack-Lehan Grade | I | 68 Participants |
| 70 Degree | Cormack-Lehan Grade | III | 2 Participants |
| 70 Degree | Cormack-Lehan Grade | II | 9 Participants |
Secondary
Difficulty of Intubation Measured Using Visual Analogue Scale
Difficulty of intubation will be measured using visual analogue scale (0:easiest, 100:most difficult).
Time frame: Intraoperative intubation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 90 Degree | Difficulty of Intubation Measured Using Visual Analogue Scale | 35 units on a scale | Standard Deviation 29 |
| 70 Degree | Difficulty of Intubation Measured Using Visual Analogue Scale | 22 units on a scale | Standard Deviation 24 |
Secondary
Heart Rate
Heart rates are measured before and 2 min after intubation.
Time frame: Intraoperative intubation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 90 Degree | Heart Rate | Before intubation | 73 beats per minute | Standard Deviation 15 |
| 90 Degree | Heart Rate | 2 min after intubation | 93 beats per minute | Standard Deviation 19 |
| 70 Degree | Heart Rate | Before intubation | 73 beats per minute | Standard Deviation 17 |
| 70 Degree | Heart Rate | 2 min after intubation | 93 beats per minute | Standard Deviation 16 |
Secondary
Mallampati Grade
The Mallapati grade was assessed as I/II/III/IV (I: Soft palate, uvula, fauces, pillars visible, II: Soft palate, uvula, fauces visible, III: Soft palate, base of uvula visible, IV: Only hard palate visible). Grade I was considered better outcomes.
Time frame: Intraoperative anesthetic induction
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 90 Degree | Mallampati Grade | I | 36 Participants |
| 90 Degree | Mallampati Grade | II | 25 Participants |
| 90 Degree | Mallampati Grade | III | 10 Participants |
| 90 Degree | Mallampati Grade | IV | 7 Participants |
| 70 Degree | Mallampati Grade | IV | 6 Participants |
| 70 Degree | Mallampati Grade | I | 32 Participants |
| 70 Degree | Mallampati Grade | III | 8 Participants |
| 70 Degree | Mallampati Grade | II | 33 Participants |
Secondary
Mean Blood Pressure
Mean blood pressure is measured before and 2 min after intubation.
Time frame: Intraoperative intubation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 90 Degree | Mean Blood Pressure | Before intubation | 77 mmHg | Standard Deviation 12 |
| 90 Degree | Mean Blood Pressure | 2 min after intubation | 105 mmHg | Standard Deviation 22 |
| 70 Degree | Mean Blood Pressure | Before intubation | 78 mmHg | Standard Deviation 14 |
| 70 Degree | Mean Blood Pressure | 2 min after intubation | 108 mmHg | Standard Deviation 25 |
Secondary
Number of Participants for Whom External Laryngeal Manipulation Was Necessary
External laryngeal manipulation is defined as the compression of neck for the facilitation of laryngeal view. Number of participants for whom external laryngeal manipulation was necessary will be measured.
Time frame: Intraoperative intubation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 90 Degree | Number of Participants for Whom External Laryngeal Manipulation Was Necessary | 14 Participants |
| 70 Degree | Number of Participants for Whom External Laryngeal Manipulation Was Necessary | 3 Participants |
Secondary
Postoperative Sore Throat Measured Using Visual Analogue Scale
Postoperative sore throat will be measured using visual analogue scale (0:no pain, 100: worst pain imaginable)
Time frame: at 1, 24 hr postoperatively
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 90 Degree | Postoperative Sore Throat Measured Using Visual Analogue Scale | 1 h postoperatively | 16 units on a scale | Standard Deviation 27 |
| 90 Degree | Postoperative Sore Throat Measured Using Visual Analogue Scale | 24 h postoperatively | 10 units on a scale | Standard Deviation 20 |
| 70 Degree | Postoperative Sore Throat Measured Using Visual Analogue Scale | 24 h postoperatively | 8 units on a scale | Standard Deviation 18 |
| 70 Degree | Postoperative Sore Throat Measured Using Visual Analogue Scale | 1 h postoperatively | 13 units on a scale | Standard Deviation 25 |
Secondary
Success Rate of Intubation
The number of patients in which the intubation was successful at the first time.
Time frame: Intraoperative intubation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 90 Degree | Success Rate of Intubation | 68 Participants |
| 70 Degree | Success Rate of Intubation | 79 Participants |
Secondary
Thyromental Distance
The thyromental distance was measured.
Time frame: Intraoperative anesthetic induction
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 90 Degree | Thyromental Distance | 79.1 mm | Standard Deviation 23.6 |
| 70 Degree | Thyromental Distance | 78.5 mm | Standard Deviation 24.5 |