ObesityNCT00667693
Pentax Airway Scope (AWS) Intubation
A study testing Macintosh laryngoscope and Pentax AWS in people with Obesity, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Macintosh laryngoscope and Pentax AWS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Mar 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subject is at least 18 years old
- BMI between 30 and 50
- scheduled for elective surgery requiring orotracheal intubation
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Comparison Between the Pentax AWS Video Laryngoscope and the Macintosh Laryngoscope
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Macintosh laryngoscope, Pentax AWS
- Keywords
- intubation, obese
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macintosh laryngoscopeDevice
Intubation with Macintosh laryngoscope
Pentax AWSDevice
Intubation with Pentax AWS
| Study group | Role | What they receive |
|---|---|---|
| Macintosh laryngoscope | Active comparator | Intubation with a Macintosh laryngoscope Receives: Device: Macintosh laryngoscope |
| Pentax AWS | Active comparator | Intubation with a Pentax AWS Receives: Device: Pentax AWS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Intubation
time between sufficient muscle relaxant and placement of intubation tube
Measured: time between sufficient muscle relaxant and placement of intubation tube, up to 100 seconds
Secondary outcomes (4)
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
Measured: 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
Measured: 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.
Measured: From the start of intubation until 24 hours after surgery
The Number of Patients With Bleeding
Measured: From the start of intubation until 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2008 (estimated)
- Study startFeb 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel I Sessler, MD, Study chair, The Cleveland ClinicJohn Doyle, MD, PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00667693
- Sponsor's protocol ID
- 08-046
- Status last verified
- Jul 2018
- First submitted
- 24 Apr 2008
- Last updated
- 24 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison Between the Pentax AWS Video Laryngoscope and the Macintosh Laryngoscope
- ClinicalTrials.gov ID
- NCT00667693
- Acronym / sponsor ID
- 08-046
- Conditions
- Obesity
- Keywords
- intubation, obese
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 28 Apr 2008 (estimated)
- Results
- Posted 31 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Macintosh laryngoscope | Active comparator | Device: Macintosh laryngoscopeIntubation with a Macintosh laryngoscope |
| Pentax AWS | Active comparator | Device: Pentax AWSIntubation with a Pentax AWS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- subject is at least 18 years old
- BMI between 30 and 50
- scheduled for elective surgery requiring orotracheal intubation
Key exclusion criteria (7 listed)
- a known difficult airway
- loose teeth
- subject pregnancy
- rapid sequence induction required
- subject is unable to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Macintosh laryngoscopeIntubation with Macintosh laryngoscope | Device | Macintosh laryngoscope |
| Pentax AWSIntubation with Pentax AWS | Device | Pentax AWS |
Primary outcome
Time to Intubation
Time frame: time between sufficient muscle relaxant and placement of intubation tube, up to 100 seconds
time between sufficient muscle relaxant and placement of intubation tube
4 secondary outcomes
Ease of Intubation
Time frame: From the start of intubation until 24 hours after surgery
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel I Sessler, MD study chair
The Cleveland Clinic
John Doyle, MD, PhD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Macintosh laryngoscope and Pentax AWS in people with Obesity, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Intubation (time frame: time between sufficient muscle relaxant and placement of intubation tube, up to 100 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2018.