Oral Intubation
Conditions
Keywords
elective general surgery, orotracheal intubation, Patients would be eligible for inclusion if they were at least 18 years old and scheduled for elective surgery requiring orotracheal intubation.
Brief summary
Following informed consent, patients will be randomly assigned to oral fiberoptic intubation or to oral intubation using the GlideScope Video Laryngoscope. Following the induction of general anesthesia a sealed envelope would be opened to reveal the technique to be used. A stop watch will be started at the beginning of the procedure. At the completion of intubation the stop watch will be stopped and the time recorded along with other data. Based on a sample size estimation process, it is the investigators plan to study fifty patients. The two techniques will be compared in terms of the average time needed to place the endotracheal tube and studied using a two-sided T-Test with a significance level of 0.05. To ensure comparability between the two methods, all intubators will be required to have at experienced at least 10 uses of the GlideScope and 10 uses with fiberoptic intubation.
Interventions
DEVICEIntubation with Fiberoptic laryngoscope
Subjects will be intubated with the Fiberoptic laryngoscope.
Patients will be intubated with the GlideScope® Video Laryngoscope.
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* at least 18 years old * scheduled for elective surgery requiring orotracheal intubation.
Exclusion criteria
* known, difficult airway * loose teeth * pregnant * require a rapid sequence induction, * Body Mass Index under 30 * unable to give consent * if special endotracheal tube (ETT) is needed for the case.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Intubation (TTI) as Measured in Seconds | from start of intubation to successfully intubated up to 100 seconds | Time from insertion of either the GlideScope or in the case of fibreoptic intubation, a Williams airway (SunMed, Largo, FL, USA) into the mouth, to the time when end-tidal PCO2 exceeded 2.7 kPa (20 mmHg). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Successful Intubation on 1st Attempt | from start of first intubation to end of first intubation attempt | — |
| Occurrence of Hypoxaemia | at 1 min prior to intubation, intubation, and 2, 4, 6, 8, and 10 min after | Arterial oxygen saturation was recorded at 1 min prior to intubation, intubation, and 2, 4, 6, 8, and 10 min after; hypoxaemia was defined as occurrence of arterial oxygen saturation \<90% at any of the above measurements. |
| Intubation Difficulty Score | from start of intubation to successfully intubated | Intubation difficulty score is a 100-mm-long visual analogue scale (100 mm = extremely difficult); |
| Sore Throat Grade | On the first postoperative day | — |
| Number of Intubation Attempts | from start of intubation to successfully intubated | — |
| Trace Bleeding | Right after intubation | Trace bleeding is a binary outcome: yes or no, which is determined based on amount of post-intubation bleeding present in the suction tube |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fiberoptic Intubation Subjects will be intubated with the Fiberoptic laryngoscope.
Intubation with Fiberoptic laryngoscope: Subjects will be intubated with the Fiberoptic laryngoscope. | 37 |
| GlideScope® Video Laryngoscope Subjects will be intubated with the GlideScope® Video Laryngoscope.
GlideScope® Video Laryngoscope: Patients will be intubated with the GlideScope® Video Laryngoscope. | 38 |
| Total | 75 |
Baseline characteristics
| Characteristic | Fiberoptic Intubation | GlideScope® Video Laryngoscope | Total |
|---|---|---|---|
| Age, Continuous | 54 years STANDARD_DEVIATION 11 | 52 years STANDARD_DEVIATION 16 | 53 years STANDARD_DEVIATION 13 |
| ASA physical status I: A normal healthy patient | 1 participants | 3 participants | 4 participants |
| ASA physical status II: A patient with mild systemic disease | 21 participants | 18 participants | 39 participants |
| ASA physical status III: A patient with severe systemic disease | 15 participants | 17 participants | 32 participants |
| Body mass index | 37 kg/m^2 | 36 kg/m^2 | 37 kg/m^2 |
| Gender Female | 18 Participants | 26 Participants | 44 Participants |
| Gender Male | 19 Participants | 12 Participants | 31 Participants |
| Height | 171 cm STANDARD_DEVIATION 12 | 167 cm STANDARD_DEVIATION 10 | 169 cm STANDARD_DEVIATION 11 |
| Modified Mallampati classification III: Soft palate, base of uvula visible. | 10 participants | 8 participants | 18 participants |
| Modified Mallampati classification II: Soft palate, uvula, fauces visible. | 19 participants | 19 participants | 38 participants |
| Modified Mallampati classification I: Soft palate, uvula, fauces, pillars visible. | 7 participants | 8 participants | 15 participants |
| Modified Mallampati classification IV: Only hard palate visible. | 1 participants | 2 participants | 3 participants |
| Race/Ethnicity, Customized Caucasian | 36 participants | 33 participants | 69 participants |
| Race/Ethnicity, Customized Others | 1 participants | 5 participants | 6 participants |
| Region of Enrollment United States | 37 participants | 38 participants | 75 participants |
| Weight | 117 Kg | 104 Kg | 110 Kg |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 37 | 0 / 38 |
| serious Total, serious adverse events | 0 / 37 | 0 / 38 |
Outcome results
Primary
Time to Intubation (TTI) as Measured in Seconds
Time from insertion of either the GlideScope or in the case of fibreoptic intubation, a Williams airway (SunMed, Largo, FL, USA) into the mouth, to the time when end-tidal PCO2 exceeded 2.7 kPa (20 mmHg).
Time frame: from start of intubation to successfully intubated up to 100 seconds
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Active Comparator: Fiberoptic Intubation | Time to Intubation (TTI) as Measured in Seconds | 43 seconds |
| GlideScope® Video Laryngoscope | Time to Intubation (TTI) as Measured in Seconds | 37 seconds |
p-value: 0.19Regression, Cox
Secondary
Intubation Difficulty Score
Intubation difficulty score is a 100-mm-long visual analogue scale (100 mm = extremely difficult);
Time frame: from start of intubation to successfully intubated
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Active Comparator: Fiberoptic Intubation | Intubation Difficulty Score | 20 units on a scale |
| GlideScope® Video Laryngoscope | Intubation Difficulty Score | 15 units on a scale |
p-value: 0.5895% CI: [0.58, 1.35]ANCOVA
Secondary
Number of Intubation Attempts
Time frame: from start of intubation to successfully intubated
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Active Comparator: Fiberoptic Intubation | Number of Intubation Attempts | 1 | 31 participants |
| Active Comparator: Fiberoptic Intubation | Number of Intubation Attempts | 2 | 3 participants |
| Active Comparator: Fiberoptic Intubation | Number of Intubation Attempts | 3 | 2 participants |
| Active Comparator: Fiberoptic Intubation | Number of Intubation Attempts | 4 | 1 participants |
| GlideScope® Video Laryngoscope | Number of Intubation Attempts | 4 | 1 participants |
| GlideScope® Video Laryngoscope | Number of Intubation Attempts | 1 | 36 participants |
| GlideScope® Video Laryngoscope | Number of Intubation Attempts | 3 | 0 participants |
| GlideScope® Video Laryngoscope | Number of Intubation Attempts | 2 | 1 participants |
Secondary
Occurrence of Hypoxaemia
Arterial oxygen saturation was recorded at 1 min prior to intubation, intubation, and 2, 4, 6, 8, and 10 min after; hypoxaemia was defined as occurrence of arterial oxygen saturation \<90% at any of the above measurements.
Time frame: at 1 min prior to intubation, intubation, and 2, 4, 6, 8, and 10 min after
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active Comparator: Fiberoptic Intubation | Occurrence of Hypoxaemia | 2 participants |
| GlideScope® Video Laryngoscope | Occurrence of Hypoxaemia | 4 participants |
p-value: 0.5795% CI: [0.28, 10.2]Cochran-Mantel-Haenszel
Secondary
Sore Throat Grade
Time frame: On the first postoperative day
Population: This outcome was not collected for 1 patient in each group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Active Comparator: Fiberoptic Intubation | Sore Throat Grade | None | 19 participants |
| Active Comparator: Fiberoptic Intubation | Sore Throat Grade | Mild | 14 participants |
| Active Comparator: Fiberoptic Intubation | Sore Throat Grade | Moderate | 2 participants |
| Active Comparator: Fiberoptic Intubation | Sore Throat Grade | Severe | 1 participants |
| GlideScope® Video Laryngoscope | Sore Throat Grade | Severe | 2 participants |
| GlideScope® Video Laryngoscope | Sore Throat Grade | None | 21 participants |
| GlideScope® Video Laryngoscope | Sore Throat Grade | Moderate | 3 participants |
| GlideScope® Video Laryngoscope | Sore Throat Grade | Mild | 11 participants |
p-value: 0.8295% CI: [0.45, 2.76]Regression, Logistic
Secondary
Successful Intubation on 1st Attempt
Time frame: from start of first intubation to end of first intubation attempt
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active Comparator: Fiberoptic Intubation | Successful Intubation on 1st Attempt | 31 participants |
| GlideScope® Video Laryngoscope | Successful Intubation on 1st Attempt | 36 participants |
p-value: 0.1595% CI: [0.95, 1.33]Cochran-Mantel-Haenszel
Secondary
Trace Bleeding
Trace bleeding is a binary outcome: yes or no, which is determined based on amount of post-intubation bleeding present in the suction tube
Time frame: Right after intubation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active Comparator: Fiberoptic Intubation | Trace Bleeding | 1 participants |
| GlideScope® Video Laryngoscope | Trace Bleeding | 1 participants |
p-value: 0.7995% CI: [0.93, 1.09]Cochran-Mantel-Haenszel