Obesity
Conditions
Keywords
intubation, obese
Brief summary
This study will compare the Macintosh laryngoscope with the Pentax. The Pentax AWS is a novel airway management device that is designed to facilitate laryngoscopy and endotracheal intubation.
Detailed description
100 obese patients (BMI 30 to 50) requiring orotracheal intubation for elective surgery will be randomly allocated to intubation with either a conventional Macintosh laryngoscope or with the Pentax AWS. Our study hypothesis is that use of Pentax AWS will make tracheal intubation easier to perform in the obese surgical patient (BMI 30 to 50), as evidenced by the time to complete the intubation process as well as an Ease of Use visual analog score (VAS) measure.
Interventions
DEVICEMacintosh laryngoscope
Intubation with Macintosh laryngoscope
DEVICEPentax AWS
Intubation with Pentax AWS
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* subject is at least 18 years old * BMI between 30 and 50 * scheduled for elective surgery requiring orotracheal intubation
Exclusion criteria
* a known difficult airway * loose teeth * subject pregnancy * rapid sequence induction required * subject is unable to give consent * anesthesiologist considered use of the Pentax AWS to be contraindicated * special endotracheal tube (ETT) is needed for the case.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Intubation | time between sufficient muscle relaxant and placement of intubation tube, up to 100 seconds | time between sufficient muscle relaxant and placement of intubation tube |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ease of Intubation | From the start of intubation until 24 hours after surgery | Ease of intubation was recorded by the operator immediately after intubation on a 100 mm visual analog scale (VAS). The score ranges from 0 to 100. A higher score indicates more difficulty in intubation |
| Successful Intubation on the First Attempt | From the start of intubation until 24 hours after surgery | The count number of successful intubation on the first attempt |
| The Number of Patients With Different Number of Intubation Attempts | From the start of intubation until 24 hours after surgery | We summarized the number of patients with one, two or three intubation attempts. |
| The Number of Patients With Bleeding | From the start of intubation until 24 hours after surgery | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Macintosh Intubation with a Macintosh laryngoscope
Macintosh intubation: Macintosh intubation | 49 |
| Pentax intubation with a the Pentax AWS
Pentax AWS: Intubation with Pentax AWS | 50 |
| Total | 99 |
Baseline characteristics
| Characteristic | Macintosh | Pentax | Total |
|---|---|---|---|
| Age, Continuous | 49 years STANDARD_DEVIATION 14 | 50 years STANDARD_DEVIATION 12 | 49 years STANDARD_DEVIATION 13 |
| ASA status III: severe systemic disease | 40 participants | 32 participants | 72 participants |
| ASA status II: mild systemic disease | 7 participants | 15 participants | 22 participants |
| ASA status IV: severe systemic disease that threats to life | 2 participants | 3 participants | 5 participants |
| Mallampati score 1: Soft palate, uvula, fauces, pillars visible | 14 participants | 21 participants | 35 participants |
| Mallampati score 2: Soft palate, uvula, fauces visible | 21 participants | 18 participants | 39 participants |
| Mallampati score 3: Soft palate, base of uvula visible | 13 participants | 7 participants | 20 participants |
| Mallampati score 4: Only hard palate visible | 0 participants | 4 participants | 4 participants |
| Region of Enrollment United States | 49 participants | 50 participants | 99 participants |
| Sex: Female, Male Female | 39 Participants | 39 Participants | 78 Participants |
| Sex: Female, Male Male | 10 Participants | 11 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 49 | 0 / 50 |
| serious Total, serious adverse events | 0 / 49 | 0 / 50 |
Outcome results
Primary
Time to Intubation
time between sufficient muscle relaxant and placement of intubation tube
Time frame: time between sufficient muscle relaxant and placement of intubation tube, up to 100 seconds
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Macintosh | Time to Intubation | 26 seconds |
| Pentax | Time to Intubation | 38 seconds |
p-value: <0.00195% CI: [0.23, 0.55]Regression, Cox
Secondary
Ease of Intubation
Ease of intubation was recorded by the operator immediately after intubation on a 100 mm visual analog scale (VAS). The score ranges from 0 to 100. A higher score indicates more difficulty in intubation
Time frame: From the start of intubation until 24 hours after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Macintosh | Ease of Intubation | 40 units on a scale | Standard Deviation 28 |
| Pentax | Ease of Intubation | 52 units on a scale | Standard Deviation 31 |
Secondary
Successful Intubation on the First Attempt
The count number of successful intubation on the first attempt
Time frame: From the start of intubation until 24 hours after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Macintosh | Successful Intubation on the First Attempt | 45 Participants |
| Pentax | Successful Intubation on the First Attempt | 43 Participants |
Secondary
The Number of Patients With Bleeding
Time frame: From the start of intubation until 24 hours after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Macintosh | The Number of Patients With Bleeding | 0 Participants |
| Pentax | The Number of Patients With Bleeding | 2 Participants |
Secondary
The Number of Patients With Different Number of Intubation Attempts
We summarized the number of patients with one, two or three intubation attempts.
Time frame: From the start of intubation until 24 hours after surgery
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Macintosh | The Number of Patients With Different Number of Intubation Attempts | one attempt | 45 Participants |
| Macintosh | The Number of Patients With Different Number of Intubation Attempts | two attempts | 4 Participants |
| Macintosh | The Number of Patients With Different Number of Intubation Attempts | three attempts | 0 Participants |
| Pentax | The Number of Patients With Different Number of Intubation Attempts | one attempt | 44 Participants |
| Pentax | The Number of Patients With Different Number of Intubation Attempts | two attempts | 3 Participants |
| Pentax | The Number of Patients With Different Number of Intubation Attempts | three attempts | 3 Participants |