Sleep Apnea, ObstructivePhase 4NCT01428570
Comparison of the Pentax AWS® With the Macintosh Laryngoscopic Intubation in Obstructive Sleep Apnea Syndrome Patients
A Phase 4 study testing Pentax-AWS (AWS; Pentax Corporation, Tokyo, Japan) in people with Sleep Apnea, Obstructive, run by Kyunghee University Medical Center at 1 site in South Korea.
Trial summary
The Pentax-AWS_ system (AWS; Pentax Corporation, Tokyo, Japan) is a new rigid indirect laryngoscope which has an integrated tube passage function. Pentax-AWS improved the laryngeal view and facilitated tracheal intubation in patients with restricted neck motion. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- Pentax-AWS (AWS; Pentax Corporation, Tokyo, Japan)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2011to Oct 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status 1-3 patients,
- aged 20years or older,
- undergoing uvulopalatopharyngoplasty(UPPP) surgery under general anesthesia for a polysomnography-confirmed diagnosis of OSAS.
Who cannot join
- unstable teeth or mouth opening of < 18mm
- Patients with any pathology of the neck,
- upper respiratory tract or upper alimentary tracts,
- risk of pulmonary aspiration of gastric contents,
- a history of relevant drug allergy.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Kyung Hee university hospital
Seoul, 130-701
Mi Kyeong Kim, Professor, 82-2-958-8604 ext. 82-2-958-8114, mkanes@gmail.com
Mi Kyeong Kim, Professor
About this study
Official title: Comparison of the Pentax AWS® With the Macintosh Laryngoscope for Tracheal Intubation in Patients With Obstructive Sleep Apnea Syndrome: a Randomized Comparative Study
The Pentax-AWS_ system (AWS; Pentax Corporation, Tokyo, Japan) is a new rigid indirect laryngoscope which has an integrated tube passage function. Pentax-AWS improved the laryngeal view and facilitated tracheal intubation in patients with restricted neck motion. The purpose of this clinical trial was to evaluate the relative efficacy of the AWS laryngoscopes when used by experienced anesthetists in Obstructive Sleep Apnea Syndrome (OSAS) patients and to compare its performance with the Macintosh laryngoscope.
Read the detailed description
The occurrence of difficult intubation in OSAS patients is higher than in age and sex matched control patients. The Pentax-AWS_ system (AWS; Pentax Corporation, Tokyo, Japan) is a new rigid indirect laryngoscope which has an integrated tube passage function. Several studies reported that Pentax-AWS improved the laryngeal view and guide also facilitated rapid, easy and reliable tracheal intubation in patients undergoing elective surgery. The purpose of this clinical trial was to evaluate the relative efficacy of the AWS laryngoscopes when used by experienced anesthetists in OSAS patients and to compare its performance with the Macintosh laryngoscope. The investigators hypothesized that, in comparison with the Macintosh, AWS would reduce intubation difficulty, as measured by the intubation difficulty scale (IDS) score.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- Pentax-AWS (AWS; Pentax Corporation, Tokyo, Japan)
- Keywords
- sleep apnea, obstructive, intubation
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pentax-AWS (AWS; Pentax Corporation, Tokyo, Japan)Device
Each group of patients will be intubated using the Macintosh laryngoscope or Pentax-AWS.
| Study group | Role | What they receive |
|---|---|---|
| Pentax-AWS | Experimental | Patients in this group will be intubated using Pentax-AWS Receives: Device: Pentax-AWS (AWS; Pentax Corporation, Tokyo, Japan) |
| laryngoscopy | Active comparator | Patients in this group will be intubated using Macintosh laryngoscope. Receives: Device: Pentax-AWS (AWS; Pentax Corporation, Tokyo, Japan) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation Difficulty Scale(IDS) score
IDS score will be recorded within 10 minute after the end of intubation.
Measured: After the end of intubation (within 10 minute after the end of intubation.)
Secondary outcomes (1)
Cormack and Lehane grade
Cormack and Lehane grade will be recorded within 10 minute after the end of intubation.
Measured: After the end of intubation (within 10 minute after the end of intubation.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionSep 2011 (estimated)
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyunghee University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mi Kyeong Kim, Kyunghee University Medical Center
- Investigators
- Mi Kyeong Kim, Professor, Principal investigator, Kyung Hee University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01428570
- Sponsor's protocol ID
- PEN
- Status last verified
- Sep 2011
- First submitted
- 31 Aug 2011
- Last updated
- 5 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Pentax AWS® With the Macintosh Laryngoscope for Tracheal Intubation in Patients With Obstructive Sleep Apnea Syndrome: a Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT01428570
- Acronym / sponsor ID
- PEN
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- sleep apnea, obstructive, intubation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kyunghee University Medical CenterUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 5 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Pentax-AWS_ system (AWS; Pentax Corporation, Tokyo, Japan) is a new rigid indirect laryngoscope which has an integrated tube passage function. Pentax-AWS improved the laryngeal view and facilitated tracheal intubation in patients with restricted neck motion. The purpose of this clinical trial was to evaluate the relative efficacy of the AWS laryngoscopes when used by experienced anesthetists in Obstructive Sleep Apnea Syndrome (OSAS) patients and to compare its performance with the Macintosh laryngoscope.
Detailed description
The occurrence of difficult intubation in OSAS patients is higher than in age and sex matched control patients. The Pentax-AWS_ system (AWS; Pentax Corporation, Tokyo, Japan) is a new rigid indirect laryngoscope which has an integrated tube passage function. Several studies reported that Pentax-AWS improved the laryngeal view and guide also facilitated rapid, easy and reliable tracheal intubation in patients undergoing elective surgery. The purpose of this clinical trial was to evaluate the relative efficacy of the AWS laryngoscopes when used by experienced anesthetists in OSAS patients and to compare its performance with the Macintosh laryngoscope. The investigators hypothesized that, in comparison with the Macintosh, AWS would reduce intubation difficulty, as measured by the intubation difficulty scale (IDS) score.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pentax-AWS | Experimental | Device: Pentax-AWS (AWS; Pentax Corporation, Tokyo, Japan)Patients in this group will be intubated using Pentax-AWS |
| laryngoscopy | Active comparator | Device: Pentax-AWS (AWS; Pentax Corporation, Tokyo, Japan)Patients in this group will be intubated using Macintosh laryngoscope. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA physical status 1-3 patients,
- aged 20years or older,
- undergoing uvulopalatopharyngoplasty(UPPP) surgery under general anesthesia for a polysomnography-confirmed diagnosis of OSAS.
Key exclusion criteria (5 listed)
- unstable teeth or mouth opening of < 18mm
- Patients with any pathology of the neck,
- upper respiratory tract or upper alimentary tracts,
- risk of pulmonary aspiration of gastric contents,
- a history of relevant drug allergy.
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 |
|---|---|---|
| Pentax-AWS (AWS; Pentax Corporation, Tokyo, Japan)Each group of patients will be intubated using the Macintosh laryngoscope or Pentax-AWS. | Device | Pentax-AWS, laryngoscopy |
Primary outcome
Intubation Difficulty Scale(IDS) score
Time frame: After the end of intubation (within 10 minute after the end of intubation.)
IDS score will be recorded within 10 minute after the end of intubation.
1 secondary outcome
Cormack and Lehane grade
Time frame: After the end of intubation (within 10 minute after the end of intubation.)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2011.
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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.
Mi Kyeong Kim, Professor principal investigator
Kyung Hee University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pentax-AWS (AWS; Pentax Corporation, Tokyo, Japan) in people with Sleep Apnea, Obstructive, run by Kyunghee University Medical Center at 1 site in South Korea.
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 5 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: status not confirmed, as of the sponsor's last update on 5 Sep 2011. 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 South Korea. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intubation Difficulty Scale(IDS) score (time frame: After the end of intubation (within 10 minute after the end of intubation.)). 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 5 Sep 2011.