Anesthesia Insertion ComplicationNCT02048657
The Effectiveness of Foley Airway Stylet Tool on Proseal LMA Insertion
A study testing Foley Airway Stylet Tool and introducer-tool in people with Anesthesia Insertion Complication and Airway Morbidity, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
Due to its soft cuff easily folded to impede ProSeal LMA insertion, many tools are developed. The aim of the study is to investigate the efficiency of ProSeal LMA insertion guided by a soft, direct optical Foley airway stylet tool (FAST) and compared with the standard introducer-tool (I-Tool). Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia Insertion Complication, Airway Morbidity
- What is being tested?
- Foley Airway Stylet Tool and introducer-tool
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2008to Jun 2013
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients with American Society of Anesthesiologists physical status I-II
- aged 20-65 years
- requiring LMA Intubation under general anesthesia
- unlimited mouth open
- unlimited neck motion
Who cannot join
- mouth open < 3 cm
- limited neck motion
- BMI≧35 kg/m2
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Kaohsiung, 807
About this study
Official title: The Efficiency of ProSeal Laryngeal Mask Airway Insertion: Compared the Techniques of Foley Airway Stylet Tool With Introducer-Tool
Due to its soft cuff easily folded to impede ProSeal LMA insertion, many tools are developed. The aim of the study is to investigate the efficiency of ProSeal LMA insertion guided by a soft, direct optical Foley airway stylet tool (FAST) and compared with the standard introducer-tool (I-Tool).
- Being tested
- Foley Airway Stylet Tool, introducer-tool
- Keywords
- LMA, Foley Airway Stylet Tool (FAST), introducer-tool (I-Tool)
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foley Airway Stylet ToolDevice
introducer-toolDevice
| Study group | Role | What they receive |
|---|---|---|
| Foley group | Experimental | The Foley Airway Stylet Tool was used to guide ProSeal LMA insertion Receives: Device: Foley Airway Stylet Tool |
| I-Tool group | Experimental | the ProSeal LMA was inserted with a standard introducer-tool Receives: Device: introducer-tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with successful airway establishment
successful airway establishment is defined as adequate ventilation with ProSeal LMA and its alignment with viewing of proper glottic and esophageal positions.
Measured: half an hour
Secondary outcomes (2)
postoperative sore throat
sore throat recorded in recovery room and in the coming morning
Measured: 2 days
hoarseness
severity of hoarseness was recorded in recovery room and in the coming morning
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2014 (estimated)
- Study startMar 2008
- Primary completionMar 2009
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anesthesia Insertion ComplicationStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kuang I Cheng, MD, PhD., Study director, Department of anesthesiology, Kaohsiung Medical University, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02048657
- Sponsor's protocol ID
- KMHK-IRB-96023
- Status last verified
- Mar 2008
- First submitted
- 23 Oct 2013
- Last updated
- 29 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chen MK, Hsu HT, Lu IC, Shih CK, Shen YC, Tseng KY, Cheng KI. Techniques for the insertion of the ProSeal laryngeal mask airway: comparison of the Foley airway stylet tool with the introducer tool in a prospective, randomized study. BMC Anesthesiol. 2014 Nov 18;14:105. doi: 10.1186/1471-2253-14-105. eCollection 2014.
PubMed 25435806
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficiency of ProSeal Laryngeal Mask Airway Insertion: Compared the Techniques of Foley Airway Stylet Tool With Introducer-Tool
- ClinicalTrials.gov ID
- NCT02048657
- Acronym / sponsor ID
- KMHK-IRB-96023
- Keywords
- LMA, Foley Airway Stylet Tool (FAST), introducer-tool (I-Tool)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 29 Jan 2014 (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.
Due to its soft cuff easily folded to impede ProSeal LMA insertion, many tools are developed. The aim of the study is to investigate the efficiency of ProSeal LMA insertion guided by a soft, direct optical Foley airway stylet tool (FAST) and compared with the standard introducer-tool (I-Tool).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Foley group | Experimental | Device: Foley Airway Stylet ToolThe Foley Airway Stylet Tool was used to guide ProSeal LMA insertion |
| I-Tool group | Experimental | Device: introducer-toolthe ProSeal LMA was inserted with a standard introducer-tool |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients with American Society of Anesthesiologists physical status I-II
- aged 20-65 years
- requiring LMA Intubation under general anesthesia
- unlimited mouth open
- unlimited neck motion
Key exclusion criteria (3 listed)
- mouth open < 3 cm
- limited neck motion
- BMI≧35 kg/m2
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 |
|---|---|---|
| Foley Airway Stylet Tool | Device | Foley group |
| introducer-tool | Device | I-Tool group |
Primary outcome
Number of participants with successful airway establishment
Time frame: half an hour
successful airway establishment is defined as adequate ventilation with ProSeal LMA and its alignment with viewing of proper glottic and esophageal positions.
2 secondary outcomes
postoperative sore throat
Time frame: 2 days
hoarseness
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2014.
- Derived from this study: PubMed 25435806Chen MK, Hsu HT, Lu IC, Shih CK, Shen YC, Tseng KY, Cheng KI. Techniques for the insertion of the ProSeal laryngeal mask airway: comparison of the Foley airway stylet tool with the introducer tool in a prospective, randomized study. BMC Anesthesiol. 2014 Nov 18;14:105. doi: 10.1186/1471-2253-14-105. eCollection 2014.
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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.
Kuang I Cheng, MD, PhD. study director
Department of anesthesiology, Kaohsiung Medical University, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foley Airway Stylet Tool and introducer-tool in people with Anesthesia Insertion Complication and Airway Morbidity, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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 5 inclusion and 3 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 29 Jan 2014. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with successful airway establishment (time frame: half an hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02048657, which also lists 1 linked publication.
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 29 Jan 2014.