Oropharengeal Leak PressureNCT07688590
Comparison of Oropharyngeal Leak Pressures of SaCo Video Laryngeal Mask Airway (LMA) and ProSeal LMA in Adult Elective Surgery
A study testing ProSeal LMA Group (Group-P) and SaCo Video LMA Group (Group-V) in people with Oropharengeal Leak Pressure, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
To compare of oropharyngeal leak pressures of SaCo video laryngeal mask airway (LMA) and ProSeal LMA in adult elective surgery Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Oropharengeal Leak Pressure
- What is being tested?
- ProSeal LMA Group (Group-P) and SaCo Video LMA Group (Group-V)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2026to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients scheduled for electvie surgery in the general surgery, gynecology and obstetrics, urology and orthopedics departments
- Between 18-65 years
- ASA I-II group
- Mallampati scores I-II
- Patients who will undergo surgery in the supine position
- Surgeries with a planned duration of no more than 90 minutes.
Who cannot join
- Those who are outside the age range of 18-65
- Those who are ASA III and above
- Those who are Mallampati score III-IV
- Patients scheduled for emergency surgery
- Those whose condition prevents LMA implantation
- those who have had an upper respiratory tract infection in the last 4 weeks
- those with a body mass index ≥30 kg/m²
- those scheduled for laparoscopic surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Van Yuzuncu Yil University Faculty of Medicine Ethics Committee
To compare of oropharyngeal leak pressures of SaCo video laryngeal mask airway (LMA) and ProSeal LMA in adult elective surgery
Read the detailed description
The study will be conducted after obtaining an approval from the local ethics committee. The study will include 180 patients aged 18-65 years with ASA scores I-II, mallampati scores I-II, scheduled for surgery in the supine position in the general surgery, gynecology and obstetrics, urology and orthopedics departments with a planned surgery duration not exceeding 90 minutes. The patients will be randomized by sealed tender and will be divided into 2 groups with 90 patients each. All cases will receive routine preparation for general anesthesia. For anesthesia induction 2 mcg/kg fentanyl, 2 mg/kg propofol and 0.6 mg/kg rocuronium will be used. Once sufficient anesthesia depth is achieved, the patient will be prepared to receive either a SaCo video LMA or ProSeal LMA of the appropriate size, according to a randomly assigned group. The successful placement of the LMA on the first attempt, the placement duration and the oropharyngeal leak pressure will be evaluated. Successful placement will be assessed by observing a continuous trace of end tidal CO2 after LMA placement. The placement duration will begin with the practitioner holding the patient's head with their left hand and holding the LMA in their right hand. Following successful LMA placement, the cuff will be inflated using a manual cuff pressure gauge until the cuff pressure reaches 60 cm H2O and the pressure valve will be slowly closed, with the values indicating leak pressure being noted. Anesthesia will be maintained with 60% air, 40% oxygen and 1 MAC sevoflurane. If intraoperatively needed, an additional dose of 0,5 mcg/kg fentanyl and 0,15 mg/kg rocuronium will be administered. Before the end of the surgery, 15 mg/kg paracetamol and 1 mg/kg tramadol will be administered for postoperative analgesia. 4 mg/kg sugammadex will be administered as a muscle relaxant reversal agent. The LMA will be removed when the patient starts breathing spontaneously and opens their eyes in response to verbal stimulation. All data will be recorded and statistical analysis will be made.
- Conditions
- Oropharengeal Leak Pressure
- Being tested
- ProSeal LMA Group (Group-P), SaCo Video LMA Group (Group-V)
- Keywords
- oropharengeal leak pressure, laryngeal masks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProSeal LMA Group (Group-P)Procedure or surgery
Group-P: ProSeal LMA group (n:90). in adult patients scheduled for surgery, airway patency will be maintained with a ProSeal LMA
SaCo Video LMA Group (Group-V)Procedure or surgery
Group-V: SaCo Video LMA group (n:90). in adult patients scheduled for surgery, airway patency will be maintained with a SaCo LMA
| Study group | Role | What they receive |
|---|---|---|
| ProSeal LMA (Group-P) | Active comparator | Group-P: ProSeal LMA group (n:90). in adult patients scheduled for surgery, airway patency will be maintained with a ProSeal LMA Receives: Procedure: ProSeal LMA Group (Group-P) |
| SaCo Video LMA (Group-V) | Experimental | Group-V: SaCo Video LMA group (n:90). in adult patients scheduled for surgery, airway patency will be maintained with a SaCo LMA Receives: Procedure: SaCo Video LMA Group (Group-V) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oropharyngeal Leak Pressure
The oropharengeal leak pressure will be evaluated by same anaesthetist after LMA placement
Measured: Periprocedural
Secondary outcomes (2)
Successful placement of the LMA on the first attempt
Successful placement will be assessed by observing a continuous trace of end tidal CO2 after LMA placement
Measured: Periprocedural
placement duration
The placement duration will begin with the practitioner holding the patient's head with their left hand and holding the LMA in their right hand
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start1 Feb 2026
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
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 Oropharengeal Leak PressureStudies 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
- 180 adult patients scheduled for surgery will be randomly divided into two groups. After anesthesia, airway patency will be maintained in one group with a SaCo Video LMA and in the other group with a ProSeal LMA.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Emin Keskin, Yuzuncu Yil University
- Investigators
- Şükran Sevimli, Assoc. Prof., Study director, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07688590
- Sponsor's protocol ID
- 2026/01-06
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol anda statistical analysis plan will be share with other researchers
Publications
Seet E, Rajeev S, Firoz T, Yousaf F, Wong J, Wong DT, Chung F. Safety and efficacy of laryngeal mask airway Supreme versus laryngeal mask airway ProSeal: a randomized controlled trial. Eur J Anaesthesiol. 2010 Jul;27(7):602-7. doi: 10.1097/eja.0b013e32833679e3.
PubMed 20540172Maitra S, Khanna P, Baidya DK. Comparison of laryngeal mask airway Supreme and laryngeal mask airway Pro-Seal for controlled ventilation during general anaesthesia in adult patients: systematic review with meta-analysis. Eur J Anaesthesiol. 2014 May;31(5):266-73. doi: 10.1097/01.EJA.0000435015.89651.3d.
PubMed 24145803Ozden GG, Dost B, Kaya C, Turunc E, Koksal E, Ustun YB, Bilgin S, Baris S. Comparison of oropharyngeal leak pressure between the SaCoVLM video laryngeal mask and LMA supreme in adult elective surgery patients: a prospective randomized controlled trial. BMC Anesthesiol. 2025 Jul 3;25(1):334. doi: 10.1186/s12871-025-03218-4.
PubMed 40610857
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Van Yuzuncu Yil University Faculty of Medicine Ethics Committee
- ClinicalTrials.gov ID
- NCT07688590
- Acronym / sponsor ID
- 2026/01-06
- Conditions
- Oropharengeal Leak Pressure
- Keywords
- oropharengeal leak pressure, laryngeal masks
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 7 Jul 2026 (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.
To compare of oropharyngeal leak pressures of SaCo video laryngeal mask airway (LMA) and ProSeal LMA in adult elective surgery
Detailed description
The study will be conducted after obtaining an approval from the local ethics committee. The study will include 180 patients aged 18-65 years with ASA scores I-II, mallampati scores I-II, scheduled for surgery in the supine position in the general surgery, gynecology and obstetrics, urology and orthopedics departments with a planned surgery duration not exceeding 90 minutes. The patients will be randomized by sealed tender and will be divided into 2 groups with 90 patients each. All cases will receive routine preparation for general anesthesia. For anesthesia induction 2 mcg/kg fentanyl, 2 mg/kg propofol and 0.6 mg/kg rocuronium will be used. Once sufficient anesthesia depth is achieved, the patient will be prepared to receive either a SaCo video LMA or ProSeal LMA of the appropriate size, according to a randomly assigned group. The successful placement of the LMA on the first attempt, the placement duration and the oropharyngeal leak pressure will be evaluated. Successful placement will be assessed by observing a continuous trace of end tidal CO2 after LMA placement. The placement duration will begin with the practitioner holding the patient's head with their left hand and holding the LMA in their right hand. Following successful LMA placement, the cuff will be inflated using a manual cuff pressure gauge until the cuff pressure reaches 60 cm H2O and the pressure valve will be slowly closed, with the values indicating leak pressure being noted. Anesthesia will be maintained with 60% air, 40% oxygen and 1 MAC sevoflurane. If intraoperatively needed, an additional dose of 0,5 mcg/kg fentanyl and 0,15 mg/kg rocuronium will be administered. Before the end of the surgery, 15 mg/kg paracetamol and 1 mg/kg tramadol will be administered for postoperative analgesia. 4 mg/kg sugammadex will be administered as a muscle relaxant reversal agent. The LMA will be removed when the patient starts breathing spontaneously and opens their eyes in response to verbal stimulation. All data will be recorded and statistical analysis will be made.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 180 adult patients scheduled for surgery will be randomly divided into two groups. After anesthesia, airway patency will be maintained in one group with a SaCo Video LMA and in the other group with a ProSeal LMA.
| Arm | Type | Receives |
|---|---|---|
| ProSeal LMA (Group-P) | Active comparator | Procedure: ProSeal LMA Group (Group-P)Group-P: ProSeal LMA group (n:90). in adult patients scheduled for surgery, airway patency will be maintained with a ProSeal LMA |
| SaCo Video LMA (Group-V) | Experimental | Procedure: SaCo Video LMA Group (Group-V)Group-V: SaCo Video LMA group (n:90). in adult patients scheduled for surgery, airway patency will be maintained with a SaCo LMA |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients scheduled for electvie surgery in the general surgery, gynecology and obstetrics, urology and orthopedics departments
- Between 18-65 years
- ASA I-II group
- Mallampati scores I-II
- Patients who will undergo surgery in the supine position
Key exclusion criteria (8 listed)
- Those who are outside the age range of 18-65
- Those who are ASA III and above
- Those who are Mallampati score III-IV
- Patients scheduled for emergency surgery
- Those whose condition prevents LMA implantation
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 LMA Group (Group-P)Group-P: ProSeal LMA group (n:90). in adult patients scheduled for surgery, airway patency will be maintained with a ProSeal LMA | Procedure or surgery | ProSeal LMA (Group-P) |
| SaCo Video LMA Group (Group-V)Group-V: SaCo Video LMA group (n:90). in adult patients scheduled for surgery, airway patency will be maintained with a SaCo LMA | Procedure or surgery | SaCo Video LMA (Group-V) |
Primary outcome
Oropharyngeal Leak Pressure
Time frame: Periprocedural
The oropharengeal leak pressure will be evaluated by same anaesthetist after LMA placement
2 secondary outcomes
Successful placement of the LMA on the first attempt
Time frame: Periprocedural
placement duration
Time frame: Periprocedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Background: PubMed 20540172Seet E, Rajeev S, Firoz T, Yousaf F, Wong J, Wong DT, Chung F. Safety and efficacy of laryngeal mask airway Supreme versus laryngeal mask airway ProSeal: a randomized controlled trial. Eur J Anaesthesiol. 2010 Jul;27(7):602-7. doi: 10.1097/eja.0b013e32833679e3.
- Background: PubMed 24145803Maitra S, Khanna P, Baidya DK. Comparison of laryngeal mask airway Supreme and laryngeal mask airway Pro-Seal for controlled ventilation during general anaesthesia in adult patients: systematic review with meta-analysis. Eur J Anaesthesiol. 2014 May;31(5):266-73. doi: 10.1097/01.EJA.0000435015.89651.3d.
- Background: PubMed 40610857Ozden GG, Dost B, Kaya C, Turunc E, Koksal E, Ustun YB, Bilgin S, Baris S. Comparison of oropharyngeal leak pressure between the SaCoVLM video laryngeal mask and LMA supreme in adult elective surgery patients: a prospective randomized controlled trial. BMC Anesthesiol. 2025 Jul 3;25(1):334. doi: 10.1186/s12871-025-03218-4.
- Individual participant dataSharing planned: Yes. Study protocol anda statistical analysis plan will be share with other researchers
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.
Şükran Sevimli, Assoc. Prof. study director
Yuzuncu Yil University
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 LMA Group (Group-P) and SaCo Video LMA Group (Group-V) in people with Oropharengeal Leak Pressure, run by Yuzuncu Yil University 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 6 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 7 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Oropharyngeal Leak Pressure (time frame: Periprocedural). 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 NCT07688590, 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 7 Jul 2026.