An interventional study of Macintosh laryngoscope and Pentax AWS in Obesity, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-24.
Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Other
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.
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.
The Cleveland Clinic is the lead sponsor of 818 studies on the registry; 118 are open to participants now.
Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.
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Exclusion Criteria:
Intubation with a Macintosh laryngoscope
Device: Macintosh laryngoscope
Intubation with a Pentax AWS
Device: Pentax AWS
Intubation with Macintosh laryngoscope
Intubation with Pentax AWS
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
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
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
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
The Number of Patients With Bleeding
Time frame: From the start of intubation until 24 hours after surgery
| Milestone | Macintosh | Pentax |
|---|---|---|
| Started | 49 | 52 |
| Completed | 49 | 50 |
| Not completed | 0 | 2 |
time between sufficient muscle relaxant and placement of intubation tube
| seconds | Macintosh | Pentax |
|---|---|---|
| Time to Intubation | 26 (22 to 29) | 38 (31 to 50) |
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
| units on a scale | Macintosh | Pentax |
|---|---|---|
| Ease of Intubation | 40 ± 28 | 52 ± 31 |
The count number of successful intubation on the first attempt
| Participants | Macintosh | Pentax |
|---|---|---|
| Successful Intubation on the First Attempt | 45 | 43 |
We summarized the number of patients with one, two or three intubation attempts.
| Participants | Macintosh | Pentax |
|---|---|---|
| one attempt | 45 | 44 |
| two attempts | 4 | 3 |
| three attempts | 0 | 3 |
| Participants | Macintosh | Pentax |
|---|---|---|
| The Number of Patients With Bleeding | 0 | 2 |
Collected over From the start of intubation until 24 hours after surgery. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Macintosh | — | 0/49 (0%) | 0/49 (0%) |
| Pentax | — | 0/50 (0%) | 0/50 (0%) |
| Age, Continuous(years) | Macintosh | Pentax | Total |
|---|---|---|---|
| Mean | 49 ± 14 | 50 ± 12 | 49 ± 13 |
| Sex: Female, Male(Participants) | Macintosh | Pentax | Total |
|---|---|---|---|
| Female | 39 | 39 | 78 |
| Male | 10 | 11 | 21 |
| Region of Enrollment(participants) | Macintosh | Pentax | Total |
|---|---|---|---|
| United States | 49 | 50 | 99 |
| ASA status(participants) | Macintosh | Pentax | Total |
|---|---|---|---|
| II: mild systemic disease | 7 | 15 | 22 |
| III: severe systemic disease | 40 | 32 | 72 |
| IV: severe systemic disease that threats to life | 2 | 3 | 5 |
| Mallampati score(participants) | Macintosh | Pentax | Total |
|---|---|---|---|
| 1: Soft palate, uvula, fauces, pillars visible | 14 | 21 | 35 |
| 2: Soft palate, uvula, fauces visible | 21 | 18 | 39 |
| 3: Soft palate, base of uvula visible | 13 | 7 | 20 |
| 4: Only hard palate visible | 0 | 4 | 4 |
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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