Fixation Device; ComplicationsNCT05433740
LMA Fixation Method
A study testing Proseal Laryngeal mask fixation in people with Fixation Device; Complications, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Proseal laryngeal mask airway (LMA) is frequently used for safe airway management in modern anesthesia. Improper fixation of the LMA may result in subsequent displacement despite initial correct placement. Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Fixation Device; Complications
- What is being tested?
- Proseal Laryngeal mask fixation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Aug 2022to 30 Sep 2022
- 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 18 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing urologic surgery using LMA
- ASA Physical Status I-III
- Mallampati score I-II
- 18 years
Who cannot join
- Patients who did not want to participate in the study
- Restricted mouth opening
- BMI ≥ 35 kg/m2
- Risk of airway malformation and aspiration (gastroesophageal reflux, hiatal hernia, history of previous gastric surgery, GIS motility disorder)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Medical Science, Yıldırım Beyazıt Training and Research Hospital, Ankara, Turkey
Altındağ, Ankara, 06000
About this study
Official title: Comparison of Two Different Methods for ProsealTM Laryngeal Mask Fixation
Proseal laryngeal mask airway (LMA) is frequently used for safe airway management in modern anesthesia. Improper fixation of the LMA may result in subsequent displacement despite initial correct placement. In this study, researchers aimed to present the detection method researchers developed for PLMA, which is different from the classical methods.
PLMA will place with a new fixation method in adult patients in the lithotomy position who will undergo uretero-renoscopic lithotripsy. The fixation will prepare by sewing a button on one end of the adjustable elastic. Successful insertion will assess clinically (capnogram, appropriate chest excursion, and the absence of an audible leak at a peak inspiratory pressure of 20 cm H2O) and with a fiberoptic bronchoscope (FOB) (grade and distance visible to vocal cords). At the end of the operation, it will be examined whether there is any displacement.
SPSS 21.0 (Version 22.0, SPSS, Inc, Chicago, IL, USA) program will be used for statistical analysis. After applying the Shapiro-Wilk test for normality, the student's t test will be used if the distribution is normal, and the Mann-Whitey U test will be used if the distribution is not normal. Fisher's exact test or chi-square test will be used for categorical variables. Results p<0.05 will be considered significant.
Read the detailed description
Proseal laryngeal mask airway (LMA) is frequently used for safe airway management in modern anesthesia. Improper fixation of the LMA may result in subsequent displacement despite initial correct placement. In this study, researchers aimed to present the detection method researchers developed for PLMA, which is different from the classical methods.
PLMA will place with a new fixation method in adult patients in the lithotomy position who will undergo uretero-renoscopic lithotripsy. The fixation will prepare by sewing a button on one end of the adjustable elastic. Successful insertion will assess clinically (capnogram, appropriate chest excursion, and the absence of an audible leak at a peak inspiratory pressure of 20 cm H2O) and with a fiberoptic bronchoscope (FOB) (grade and distance visible to vocal cords). At the end of the operation, it will be examined whether there is any displacement.
SPSS 21.0 (Version 22.0, SPSS, Inc, Chicago, IL, USA) program will be used for statistical analysis. After applying the Shapiro-Wilk test for normality, the student's t test will be used if the distribution is normal, and the Mann-Whitey U test will be used if the distribution is not normal. Fisher's exact test or chi-square test will be used for categorical variables. Results p<0.05 will be considered significant.
- Conditions
- Fixation Device; Complications
- Being tested
- Proseal Laryngeal mask fixation
- Keywords
- laryngeal mask airway, fixation, fiberoptic bronchoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proseal Laryngeal mask fixationDevice
fixation with Proseal Laryngeal mask adjustable ligament
| Study group | Role | What they receive |
|---|---|---|
| Group I: Adjustable ligament | Experimental | In the adjustable ligament method, binding tape with a button at one end and button holes along the band was wrapped around the outer end of the bite-block section of the device. The ends of the tape were then passed over the outer end of the bite block between two tubes and adjusted at or above the ear level (except neck veins), and fixed by inserting the button through the appropriate hole. Receives: Device: Proseal Laryngeal mask fixation |
| Group II: Adhesive tape | No intervention | The laryngeal mask was fixed using the standard method using adhesive tape. |
What is being measured
The primary outcome is the main question the study is designed to answer.
laryngeal mask correct insertion and than fixation
The placement and fixation of the laryngeal mask will be evaluated by measuring the end-tidal carbon dioxide value with the aid of a capnogram, the formation of appropriate chest extension, and the absence of audible leakage at 20 cm H2O peak inspiratory pressure.
Measured: intraoperative period (From the insertion of the laryngeal mask airway to its removal at the end of the procedure)
Secondary outcomes (1)
Evaluation of successful laryngeal mask placement with a fiberoptic bronchoscope (FOB)
To evaluate the best fiberoptic bronchoscopic view while insertion of proseal laryngeal mask
Measured: intraoperative period (From the insertion of the laryngeal mask airway to its removal at the end of the procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start30 Aug 2022
- Primary completion3 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Fixation Device; ComplicationsStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group I: Adjustable ligament or Group II, adhesive tape
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Funda Atar, Diskapi Yildirim Beyazit Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05433740
- Sponsor's protocol ID
- 04.04.2022 134/13
- Status last verified
- Nov 2022
- First submitted
- 15 Jun 2022
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chandan SN, Sharma SM, Raveendra US, Rajendra Prasad B. Fiberoptic assessment of laryngeal mask airway placement: a comparison of blind insertion and insertion with the use of a laryngoscope. J Maxillofac Oral Surg. 2009 Jun;8(2):95-8. doi: 10.1007/s12663-009-0025-8. Epub 2009 Aug 11.
PubMed 23139483Garc'a-Aguado R. Fixation of the ProSeal Laryngeal Mask Airway with a gauze bandage. Anaesthesia. 2005 Jul;60(7):726. doi: 10.1111/j.1365-2044.2005.04277.x. No abstract available.
PubMed 15960739Cook TM, Lee G, Nolan JP. The ProSeal laryngeal mask airway: a review of the literature. Can J Anaesth. 2005 Aug-Sep;52(7):739-60. doi: 10.1007/BF03016565.
PubMed 16103390
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Different Methods for ProsealTM Laryngeal Mask Fixation
- ClinicalTrials.gov ID
- NCT05433740
- Acronym / sponsor ID
- 04.04.2022 134/13
- Conditions
- Fixation Device; Complications
- Keywords
- laryngeal mask airway, fixation, fiberoptic bronchoscope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- 30 Aug 2022 (actual)
- Primary completion
- 3 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 27 Jun 2022 (actual)
- 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.
Proseal laryngeal mask airway (LMA) is frequently used for safe airway management in modern anesthesia. Improper fixation of the LMA may result in subsequent displacement despite initial correct placement. In this study, researchers aimed to present the detection method researchers developed for PLMA, which is different from the classical methods.
PLMA will place with a new fixation method in adult patients in the lithotomy position who will undergo uretero-renoscopic lithotripsy. The fixation will prepare by sewing a button on one end of the adjustable elastic. Successful insertion will assess clinically (capnogram, appropriate chest excursion, and the absence of an audible leak at a peak inspiratory pressure of 20 cm H2O) and with a fiberoptic bronchoscope (FOB) (grade and distance visible to vocal cords). At the end of the operation, it will be examined whether there is any displacement.
SPSS 21.0 (Version 22.0, SPSS, Inc, Chicago, IL, USA) program will be used for statistical analysis. After applying the Shapiro-Wilk test for normality, the student's t test will be used if the distribution is normal, and the Mann-Whitey U test will be used if the distribution is not normal. Fisher's exact test or chi-square test will be used for categorical variables. Results p<0.05 will be considered significant.
Detailed description
Proseal laryngeal mask airway (LMA) is frequently used for safe airway management in modern anesthesia. Improper fixation of the LMA may result in subsequent displacement despite initial correct placement. In this study, researchers aimed to present the detection method researchers developed for PLMA, which is different from the classical methods.
PLMA will place with a new fixation method in adult patients in the lithotomy position who will undergo uretero-renoscopic lithotripsy. The fixation will prepare by sewing a button on one end of the adjustable elastic. Successful insertion will assess clinically (capnogram, appropriate chest excursion, and the absence of an audible leak at a peak inspiratory pressure of 20 cm H2O) and with a fiberoptic bronchoscope (FOB) (grade and distance visible to vocal cords). At the end of the operation, it will be examined whether there is any displacement.
SPSS 21.0 (Version 22.0, SPSS, Inc, Chicago, IL, USA) program will be used for statistical analysis. After applying the Shapiro-Wilk test for normality, the student's t test will be used if the distribution is normal, and the Mann-Whitey U test will be used if the distribution is not normal. Fisher's exact test or chi-square test will be used for categorical variables. Results p<0.05 will be considered significant.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Group I: Adjustable ligament or Group II, adhesive tape
| Arm | Type | Receives |
|---|---|---|
| Group I: Adjustable ligament | Experimental | Device: Proseal Laryngeal mask fixationIn the adjustable ligament method, binding tape with a button at one end and button holes along the band was wrapped around the outer end of the bite-block section of the device. The ends of the tape were then passed over the outer end of the bite block between two tubes and adjusted at or above the ear level (except neck veins), and fixed by inserting the button through the appropriate hole. |
| Group II: Adhesive tape | No intervention | –The laryngeal mask was fixed using the standard method using adhesive tape. |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Undergoing urologic surgery using LMA
- ASA Physical Status I-III
- Mallampati score I-II
Key exclusion criteria (4 listed)
- Patients who did not want to participate in the study
- Restricted mouth opening
- BMI ≥ 35 kg/m2
- Risk of airway malformation and aspiration (gastroesophageal reflux, hiatal hernia, history of previous gastric surgery, GIS motility disorder)
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 |
|---|---|---|
| Proseal Laryngeal mask fixationfixation with Proseal Laryngeal mask adjustable ligament | Device | Group I: Adjustable ligament |
Primary outcome
laryngeal mask correct insertion and than fixation
Time frame: intraoperative period (From the insertion of the laryngeal mask airway to its removal at the end of the procedure)
The placement and fixation of the laryngeal mask will be evaluated by measuring the end-tidal carbon dioxide value with the aid of a capnogram, the formation of appropriate chest extension, and the absence of audible leakage at 20 cm H2O peak inspiratory pressure.
1 secondary outcome
Evaluation of successful laryngeal mask placement with a fiberoptic bronchoscope (FOB)
Time frame: intraoperative period (From the insertion of the laryngeal mask airway to its removal at the end of the procedure)
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 3 Nov 2022.
- Results publication: PubMed 23139483Chandan SN, Sharma SM, Raveendra US, Rajendra Prasad B. Fiberoptic assessment of laryngeal mask airway placement: a comparison of blind insertion and insertion with the use of a laryngoscope. J Maxillofac Oral Surg. 2009 Jun;8(2):95-8. doi: 10.1007/s12663-009-0025-8. Epub 2009 Aug 11.
- Results publication: PubMed 15960739Garc'a-Aguado R. Fixation of the ProSeal Laryngeal Mask Airway with a gauze bandage. Anaesthesia. 2005 Jul;60(7):726. doi: 10.1111/j.1365-2044.2005.04277.x. No abstract available.
- Results publication: PubMed 16103390Cook TM, Lee G, Nolan JP. The ProSeal laryngeal mask airway: a review of the literature. Can J Anaesth. 2005 Aug-Sep;52(7):739-60. doi: 10.1007/BF03016565.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proseal Laryngeal mask fixation in people with Fixation Device; Complications, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
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 4 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 3 Nov 2022. 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 Turkey (Türkiye). 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?
laryngeal mask correct insertion and than fixation (time frame: intraoperative period (From the insertion of the laryngeal mask airway to its removal at the end of the procedure)). 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 NCT05433740, which also lists 3 linked publications.
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 3 Nov 2022.