Laryngeal Mask AirwayLMAP-LSNCT03453138
Usage of LMA Protector on Patients Who Undergo Laparoscopic Surgery
A study testing LMA Protector and Tracheal Intubation in people with Laryngeal Mask Airway, run by Derince Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
LMA Protector is a recently developed second generation laryngeal mask several kinds of different laryngeal masks were used for the airway management during laparoscopic surgeries. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Laryngeal Mask Airway
- What is being tested?
- LMA Protector and Tracheal Intubation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Dec 2017to 1 May 2018
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA class I-III patients
- Patients undergo laparoscopic surgeries
- Laparoscopic surgeries duration of less than 2 hours
Who cannot join
- Difficult intubation history
- BMI>35
- Open cholesistectomies
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Derince Research and Training Hospital
Kocaeli, 41900
About this study
Official title: The Comparison of Protector LMA and Endotracheal Tube in Patients Undergoing Laparoscopic Cholecystectomy Under General Anesthesia A Randomize Controlled Trial
LMA Protector is a recently developed second generation laryngeal mask several kinds of different laryngeal masks were used for the airway management during laparoscopic surgeries. However there is a lack of knowledge for the use of LMA Protector during laparoscopic surgery .In this study researchers aim to determine the effectivity of LMA Protector and plan to analyse the orofaryngeal cuff pressure and fiberoptic grading scale measurements .
Read the detailed description
Tracheal intubation may have more complications than laryngeal masks. In this study researchers aim to determine the effectivity of LMA Protector and on the otherside the heamodynamic variables and the complication rates between tracheal ıntubation and laryngeal mask insertion will be compared.
- Conditions
- Laryngeal Mask Airway
- Being tested
- LMA Protector, Tracheal Intubation
- Keywords
- laryngel mask airway, laparoscopic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMA ProtectorDevice
LMA Protector will be inserted by a blind researcher after standart anesthesia induction. The view of the larynx will be assessed using fiberoptic grading scale
Tracheal IntubationDevice
tracheal intubation will be perform after standart anaesthetic induction and heamodynamic variables including blood pressure heart rate and possible complications will be observed
| Study group | Role | What they receive |
|---|---|---|
| LMA Protector Group | Experimental | LMA Protector will be inserted by a blind researcher after standart anesthesia induction. The view of the larynx will be assessed using fiberoptic grading scale Receives: Device: LMA Protector |
| Tracheal Intubation Group | Experimental | Patients will be intubated after standart anesthesia induction and we will record heamodynamic variables. including mean blood pressure and heart rate Receives: Device: Tracheal Intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilatory efficiency pressures for the LMA Protector
Oropharyngeal pressure leak test, the peak airway pressures will be determined
Measured: Intraoperative
Secondary outcomes (2)
Feasibility of LMA Protector
The grading of fiberoptic view of larynx through the LMA Protector
Measured: Intraoperative
Ease of insertion of LMA Protector
Each attemption to insert LMA will be record.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start26 Dec 2017
- Primary completion1 May 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Laryngeal Mask AirwayStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Derince Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Zeynep Turan, Derince Training and Research Hospital
- Investigators
- Mehmet Yılmaz, MD, Principal investigator, Derince Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03453138
- Sponsor's protocol ID
- DerinceTRH-01
- Acronym
- LMAP-LS
- Status last verified
- May 2018
- First submitted
- 29 Jan 2018
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the reason is not to cause bias between the researchers
Publications
Singh K, Gurha P. Comparative evaluation of Ambu AuraGain with ProSeal laryngeal mask airway in patients undergoing laparoscopic cholecystectomy. Indian J Anaesth. 2017 Jun;61(6):469-474. doi: 10.4103/ija.IJA_163_17.
PubMed 28655951Park SY, Rim JC, Kim H, Lee JH, Chung CJ. Comparison of i-gel(R) and LMA Supreme(R) during laparoscopic cholecystectomy. Korean J Anesthesiol. 2015 Oct;68(5):455-61. doi: 10.4097/kjae.2015.68.5.455. Epub 2015 Sep 30.
PubMed 26495055
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Protector LMA and Endotracheal Tube in Patients Undergoing Laparoscopic Cholecystectomy Under General Anesthesia A Randomize Controlled Trial
- ClinicalTrials.gov ID
- NCT03453138
- Acronym / sponsor ID
- LMAP-LS / DerinceTRH-01
- Conditions
- Laryngeal Mask Airway
- Keywords
- laryngel mask airway, laparoscopic surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Derince Training and Research HospitalUniversity, hospital or other
- Study start
- 26 Dec 2017 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 5 Mar 2018 (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.
LMA Protector is a recently developed second generation laryngeal mask several kinds of different laryngeal masks were used for the airway management during laparoscopic surgeries. However there is a lack of knowledge for the use of LMA Protector during laparoscopic surgery .In this study researchers aim to determine the effectivity of LMA Protector and plan to analyse the orofaryngeal cuff pressure and fiberoptic grading scale measurements .
Detailed description
Tracheal intubation may have more complications than laryngeal masks. In this study researchers aim to determine the effectivity of LMA Protector and on the otherside the heamodynamic variables and the complication rates between tracheal ıntubation and laryngeal mask insertion will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LMA Protector Group | Experimental | Device: LMA ProtectorLMA Protector will be inserted by a blind researcher after standart anesthesia induction. The view of the larynx will be assessed using fiberoptic grading scale |
| Tracheal Intubation Group | Experimental | Device: Tracheal IntubationPatients will be intubated after standart anesthesia induction and we will record heamodynamic variables. including mean blood pressure and heart rate |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA class I-III patients
- Patients undergo laparoscopic surgeries
- Laparoscopic surgeries duration of less than 2 hours
Key exclusion criteria (3 listed)
- Difficult intubation history
- BMI>35
- Open cholesistectomies
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 |
|---|---|---|
| LMA ProtectorLMA Protector will be inserted by a blind researcher after standart anesthesia induction. The view of the larynx will be assessed using fiberoptic grading scale | Device | LMA Protector Group |
| Tracheal Intubationtracheal intubation will be perform after standart anaesthetic induction and heamodynamic variables including blood pressure heart rate and possible complications will be observed | Device | Tracheal Intubation Group |
Primary outcome
Ventilatory efficiency pressures for the LMA Protector
Time frame: Intraoperative
Oropharyngeal pressure leak test, the peak airway pressures will be determined
2 secondary outcomes
Feasibility of LMA Protector
Time frame: Intraoperative
Ease of insertion of LMA Protector
Time frame: Intraoperative
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 9 May 2018.
- Background: PubMed 28655951Singh K, Gurha P. Comparative evaluation of Ambu AuraGain with ProSeal laryngeal mask airway in patients undergoing laparoscopic cholecystectomy. Indian J Anaesth. 2017 Jun;61(6):469-474. doi: 10.4103/ija.IJA_163_17.
- Background: PubMed 26495055Park SY, Rim JC, Kim H, Lee JH, Chung CJ. Comparison of i-gel(R) and LMA Supreme(R) during laparoscopic cholecystectomy. Korean J Anesthesiol. 2015 Oct;68(5):455-61. doi: 10.4097/kjae.2015.68.5.455. Epub 2015 Sep 30.
- Individual participant dataSharing planned: No. the reason is not to cause bias between the researchers
Related trials for Laryngeal Mask Airway
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Tizanidine Premedication Versus Placebo for Laryngeal Mask Airway Insertion and Recovery in Adults Undergoing Ambulatory Surgery
Airway Management
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Comparison of Second- and Third-Generation Laryngeal Mask Airway in Pediatric Patients
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Effect of Laryngeal Mask Airway vs Endotracheal Tube on Hypothermia in Laparoscopic Hernia Surgery
Perioperative Hypothermia, Hernia, Inguinal
RecruitingPhase 4
Propofol-Ketamine Versus Sevoflurane for Laryngeal Mask Anesthesia in Pediatric Cardiac Catheterization
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Not yet recruitingPhase 4
Effect of Neuromuscular Blocking Agent Use on Video Laryngeal Mask Airway Insertion
Airway Management, Supraglottic Airway Device Insertion
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.
Mehmet Yılmaz, MD principal investigator
Derince Research and Training Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LMA Protector and Tracheal Intubation in people with Laryngeal Mask Airway, run by Derince Training 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 3 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 9 May 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 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?
Ventilatory efficiency pressures for the LMA Protector (time frame: Intraoperative). 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 NCT03453138, which also lists 2 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 9 May 2018.