IntubationNCT00814775
Comparison Between the Fastrach and CTrach Laryngeal Mask Airway
A study testing Fastrach Laryngeal Mask and CTrach Laryngeal Mask in people with Intubation, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The purpose of this study is to determine the effectiveness of the Fastrach and the CTrach Laryngeal mask airway to achieve placement of a breathing tube in the windpipe of patients where this may be difficult. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation
- What is being tested?
- Fastrach Laryngeal Mask and CTrach Laryngeal Mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Jun 2010
- 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
- Patients with an ASA score of 1-3.
- Scheduled for elective surgical procedure
- Age 18 and above
- Patients with Mallampati airway classification scores III and IV
Who cannot join
- Current pregnancy
- Patients undergoing brain aneurysm clipping brain arteriovenous malformation surgery or vascular surgery procedures
- Patients with obstructive sleep apnea or with a history of difficult ventilation
- Mouth opening less than 3 cm.
- Patients with indication for awake fiberoptic intubation or with a history of difficult intubation
- Patients with cancer of the neck or the upper airway
Show all 9Show fewer
- Emergent surgery, patients requiring rapid sequence induction
- Patients with severe gastroesophageal reflux
- Patients with severe cardiac, pulmonary, hepatic or renal co-morbidities. 10. Patients unable to consent their participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between the Fastrach and CTrach Laryngeal Mask Airway for Intubation of Patients With a Mallampati Score 3 or 4
The purpose of this study is to determine the effectiveness of the Fastrach and the CTrach Laryngeal mask airway to achieve placement of a breathing tube in the windpipe of patients where this may be difficult.
Read the detailed description
Participant will be randomly assigned to receive one of 2 conventional airway devices - the Fastrach Laryngeal Mask Airway or the CTrach Laryngeal Mask Airway. This study will compare the time required for successful intubation between the two devices.
Postoperative visit will be performed to assess the participant's clinical condition and to receive participant's feed back.
- Conditions
- Intubation
- Being tested
- Fastrach Laryngeal Mask, CTrach Laryngeal Mask
- Keywords
- Laryngeal mask, Difficult intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fastrach Laryngeal MaskDevice
Intubation of difficult airway using Fastrach Laryngeal Mask
CTrach Laryngeal MaskDevice
CTrach Laryngeal Mask intubation
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Fastrach Laryngeal Mask Airway intubation Receives: Device: Fastrach Laryngeal Mask |
| Group 2 | Active comparator | Intubation of difficult airway using CTrach Laryngeal Mask Receives: Device: CTrach Laryngeal Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Compare the Time Required for Successful Intubation Between the Fastrach and CTrach LMA Devices in Patients With a Mallampati Score III and IV Without Use of Fiberoptic Bronchoscopy
Measured: from start of intubation to successfully intubated
To Compare the Time Required for Successful Intubation Between the Fastrach and CTrach LMA Devices in Patients With a Mallampati Score III and IV Use of Fiberoptic Bronchoscopy
Measured: 60 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2008 (estimated)
- Study startAug 2008
- Primary completionJun 2010
- Study completionJun 2010
Why it stopped: recruitment challenges, device no longer available
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 IntubationStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco Maurtua, MD, Principal investigator, The Cleveland ClinicDaniel I Sessler, MD, Study chair, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00814775
- Sponsor's protocol ID
- 08-358
- Status last verified
- Aug 2016
- First submitted
- 23 Dec 2008
- Last updated
- 17 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Fastrach and CTrach Laryngeal Mask Airway for Intubation of Patients With a Mallampati Score 3 or 4
- ClinicalTrials.gov ID
- NCT00814775
- Acronym / sponsor ID
- 08-358
- Conditions
- Intubation
- Keywords
- Laryngeal mask, Difficult intubation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment challenges, device no longer available
- Enrolment
- 43 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 25 Dec 2008 (estimated)
- Results
- Posted 17 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effectiveness of the Fastrach and the CTrach Laryngeal mask airway to achieve placement of a breathing tube in the windpipe of patients where this may be difficult.
Detailed description
Participant will be randomly assigned to receive one of 2 conventional airway devices - the Fastrach Laryngeal Mask Airway or the CTrach Laryngeal Mask Airway. This study will compare the time required for successful intubation between the two devices.
Postoperative visit will be performed to assess the participant's clinical condition and to receive participant's feed back.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Device: Fastrach Laryngeal MaskFastrach Laryngeal Mask Airway intubation |
| Group 2 | Active comparator | Device: CTrach Laryngeal MaskIntubation of difficult airway using CTrach Laryngeal Mask |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with an ASA score of 1-3.
- Scheduled for elective surgical procedure
- Age 18 and above
- Patients with Mallampati airway classification scores III and IV
Key exclusion criteria (9 listed)
- Current pregnancy
- Patients undergoing brain aneurysm clipping brain arteriovenous malformation surgery or vascular surgery procedures
- Patients with obstructive sleep apnea or with a history of difficult ventilation
- Mouth opening less than 3 cm.
- Patients with indication for awake fiberoptic intubation or with a history of difficult intubation
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 |
|---|---|---|
| Fastrach Laryngeal MaskIntubation of difficult airway using Fastrach Laryngeal Mask | Device | Group 1 |
| CTrach Laryngeal MaskCTrach Laryngeal Mask intubation | Device | Group 2 |
Primary outcome
To Compare the Time Required for Successful Intubation Between the Fastrach and CTrach LMA Devices in Patients With a Mallampati Score III and IV Without Use of Fiberoptic Bronchoscopy
Time frame: from start of intubation to successfully intubated
To Compare the Time Required for Successful Intubation Between the Fastrach and CTrach LMA Devices in Patients With a Mallampati Score III and IV Use of Fiberoptic Bronchoscopy
Time frame: 60 seconds
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2016.
- 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.
Marco Maurtua, MD principal investigator
The Cleveland Clinic
Daniel I Sessler, MD study chair
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 Fastrach Laryngeal Mask and CTrach Laryngeal Mask in people with Intubation, 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 4 inclusion and 9 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: stopped early, as of the sponsor's last update on 17 Oct 2016. 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 17 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?
To Compare the Time Required for Successful Intubation Between the Fastrach and CTrach LMA Devices in Patients With a Mallampati Score III and IV Without Use of Fiberoptic Bronchoscopy (time frame: from start of intubation to successfully intubated). The study lists 2 primary outcomes in all. 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 17 Oct 2016.