Nasal Intubation
Conditions
Keywords
King Vision
Brief summary
This study was designed to determine the comparison between the King Vision video laryngoscope 、 McGrath MAC video laryngoscope and Macintosh laryngoscope for nasotracheal intubation.Patients were divided into 3 groups of 30 patients each.Patients of King Vision group \[n=30\]、 McGrath MAC group \[n=30\] and Macintosh group\[n=30\]were intubated using respective devices.This study is the first to search the use of King Vision video laryngoscope for nasotracheal intubation.
Interventions
nasal intubation using King Vision video laryngoscope Device after general anesthesia induction
nasal intubation using McGrath MAC video laryngoscope Device after general anesthesia induction
DEVICEMacintosh laryngoscope
nasal intubation using Macintosh laryngoscope Device after general anesthesia induction
Sponsors
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* ASA physical status 1-2 * general anesthesia with nasotracheal intubation * anticipated difficult airway
Exclusion criteria
* contraindications to nasal intubation * Patients with a history of anti-hypertensive drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Intubation | 0 min after nasal intubation | the interval between opening the mouth and the time when three consecutive end-tidal CO2 waves were appeared on the monitor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Laryngoscopy Time | after expose the glottis | time to expose the glottis |
| Number of Participants With Complications | 24h after surgery | sore throat, hoarseness, etc |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| King Vision Video Laryngoscope King Vision video laryngoscope: nasal intubation using King Vision video laryngoscope Device after general anesthesia induction | 33 |
| McGrath MAC Video Laryngoscope McGrath MAC video laryngoscope: nasal intubation using McGrath MAC video laryngoscope Device after general anesthesia induction | 33 |
| Macintosh Macintosh laryngoscope: nasal intubation using Macintosh laryngoscope Device after general anesthesia induction | 33 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 5 |
Baseline characteristics
| Characteristic | King Vision Video Laryngoscope | McGrath MAC Video Laryngoscope | Macintosh | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 33 Participants | 33 Participants | 33 Participants | 99 Participants |
| Age, Continuous | 38 year STANDARD_DEVIATION 12 | 36 year STANDARD_DEVIATION 11 | 40 year STANDARD_DEVIATION 11 | 38 year STANDARD_DEVIATION 11 |
| ASA I or II | 33 Participants | 33 Participants | 33 Participants | 99 Participants |
| BMI | 22 Kg/M^2 STANDARD_DEVIATION 3 | 22 Kg/M^2 STANDARD_DEVIATION 3 | 22 Kg/M^2 STANDARD_DEVIATION 3 | 22 Kg/M^2 STANDARD_DEVIATION 3 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment China | 33 participants | 33 participants | 33 participants | 99 participants |
| Sex: Female, Male Female | 15 Participants | 19 Participants | 16 Participants | 50 Participants |
| Sex: Female, Male Male | 18 Participants | 14 Participants | 17 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 33 | 0 / 33 |
| other Total, other adverse events | 6 / 33 | 9 / 33 | 21 / 33 |
| serious Total, serious adverse events | 0 / 33 | 0 / 33 | 0 / 33 |
Outcome results
Primary
Time to Intubation
the interval between opening the mouth and the time when three consecutive end-tidal CO2 waves were appeared on the monitor
Time frame: 0 min after nasal intubation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| King Vision Video Laryngoscope | Time to Intubation | 37.6 second | Standard Deviation 7.3 |
| McGrath MAC Video Laryngoscope | Time to Intubation | 35.4 second | Standard Deviation 8.8 |
| Macintosh | Time to Intubation | 46.8 second | Standard Deviation 10.4 |
Secondary
Laryngoscopy Time
time to expose the glottis
Time frame: after expose the glottis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| King Vision Video Laryngoscope | Laryngoscopy Time | 16.7 second | Standard Deviation 5.5 |
| McGrath MAC Video Laryngoscope | Laryngoscopy Time | 15.6 second | Standard Deviation 6.3 |
| Macintosh | Laryngoscopy Time | 22.8 second | Standard Deviation 7.2 |
Secondary
Number of Participants With Complications
sore throat, hoarseness, etc
Time frame: 24h after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| King Vision Video Laryngoscope | Number of Participants With Complications | 6 Participants |
| McGrath MAC Video Laryngoscope | Number of Participants With Complications | 7 Participants |
| Macintosh | Number of Participants With Complications | 21 Participants |