Airway ManagementNCT06616740
Effects of Paratracheal Compression and Cricoid Compression on LMA ProSeal Placement
A study testing Cricoid pressure and Paratracheal pressure in people with Airway Management, run by Karaman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the effect of paratracheal and cricoid pressure on LMA ProSeal insertion, insertion time, insertion difficulty, and the rate of optimal positioning of the device after insertion. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Airway Management
- What is being tested?
- Cricoid pressure and Paratracheal pressure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Oct 2024to 16 Dec 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 19-70 years who are scheduled for general anaesthesia for whom LMA management would be appropriate.
Who cannot join
- with cervical spine disease
- expected difficult airway
- upper airway abnormalities
- body mass index (BMI) more than 35 kg/m2
- high risk of aspiration (hiatus hernia, gastro-oesophageal reflux disease and starvation)
- postoperative ventilator care
- surgeries requiring positions other than supine.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karaman Taining and Research Hospital
Karaman, 70200
About this study
Official title: Comparison of the Effects of Paratracheal Compression and Cricoid Compression on LMA ProSeal Placement: a Randomised Clinical Trial.
The aim of this study is to compare the effect of paratracheal and cricoid pressure on LMA ProSeal insertion, insertion time, insertion difficulty, and the rate of optimal positioning of the device after insertion.
- Conditions
- Airway Management
- Being tested
- Cricoid pressure, Paratracheal pressure
- Keywords
- Airway management, LMA, Cricoid pressure, Paratracheal pressure, Supraglottic airway device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cricoid pressureOther
Cricoid pressure will be applied during LMA ProSeal insertion.
Paratracheal pressureOther
Pratracheal pressure will be applied during LMA ProSeal insertion.
| Study group | Role | What they receive |
|---|---|---|
| Cricoid pressure group | Sham comparator | Cricoid pressure will be applied during LMA ProSeal insertion. Receives: Other: Cricoid pressure |
| Paratracheal pressure group | Experimental | Paratracheal pressure will be applied during LMA ProSeal insertion. Receives: Other: Paratracheal pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of insertion
The time required for placement will be defined as the time from receipt of the LMA ProSeal to detection of the square waveform on capnography and will be calculated by summing the time taken for each attempt.
Measured: During intubation procedure
Secondary outcomes (4)
Sensation of resistance during inserting of LMA ProSeal
Insertion of the LMA ProSeal will be assessed on a 4-point scale (1, no resistance; 2, moderate resistance; 3, severe resistance; and 4, impossible to insert the LMA ProSeal).
Measured: During intubation procedure
Anatomical location of the LMA ProSeal in the larynx and accuracy of insertion site.
It will be evaluated with a fibreoptic bronchoscope placed inside the tube section of the the LMA ProSeal. Accuracy will be recorded on a five-point scale (1, only the glottis is observed; 2, the posterior surface of the epiglottis and the glottis are observed; 3, the anterior part or tip of the epiglottis and >50% of the glottis are observed; 4, the folded down epiglottis and <50% of the glottis are observed; 5, the glottis is completely hidden by the folded down epiglottis)
Measured: 1 minutes after intubation
Tidal volume and peak inspiratory pressure with or without each maneuver after LMA ProSeal insertion.
Tidal volume and peak inspiratory pressure with or without manoeuvre will be recorded with the same ventilator settings determined for all patients.
Measured: 2 minutes after intubation
Oropharyngeal leak pressure
Oropharyngeal leak pressure will be assessed by closing the expiratory valve of the circle system to 40 cmH2o, with a fresh gas flow of 3 L/min and noting the airway pressure when equilibrium is reached or an audible air leak occurs.
Measured: 5 minutes after induction of general anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start24 Oct 2024
- Primary completion15 Dec 2024
- Study completion16 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ManagementStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are two groups; 1. Experimental Group: Group P; paratracheal compression will be applied during LMA ProSeal insertion. 2. Sham Comparator: Group C; cricoid compression will be applied during LMA ProSeal insertion.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karaman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, muhammet korkusuz, Karaman Training and Research Hospital
- Investigators
- Muhammet Korkusuz, MD, Principal investigator, Karamanoglu Mehmetbey University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06616740
- Sponsor's protocol ID
- 04-2024/16
- Status last verified
- Jan 2025
- First submitted
- 23 Sep 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Paratracheal Compression and Cricoid Compression on LMA ProSeal Placement: a Randomised Clinical Trial.
- ClinicalTrials.gov ID
- NCT06616740
- Acronym / sponsor ID
- 04-2024/16
- Conditions
- Airway Management
- Keywords
- Airway management, LMA, Cricoid pressure, Paratracheal pressure, Supraglottic airway device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Karaman Training and Research HospitalUniversity, hospital or other
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 16 Dec 2024 (actual)
- First posted
- 27 Sep 2024 (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.
The aim of this study is to compare the effect of paratracheal and cricoid pressure on LMA ProSeal insertion, insertion time, insertion difficulty, and the rate of optimal positioning of the device after insertion.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- There are two groups; 1. Experimental Group: Group P; paratracheal compression will be applied during LMA ProSeal insertion. 2. Sham Comparator: Group C; cricoid compression will be applied during LMA ProSeal insertion.
| Arm | Type | Receives |
|---|---|---|
| Cricoid pressure group | Sham comparator | Other: Cricoid pressureCricoid pressure will be applied during LMA ProSeal insertion. |
| Paratracheal pressure group | Experimental | Other: Paratracheal pressureParatracheal pressure will be applied during LMA ProSeal insertion. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 19-70 years who are scheduled for general anaesthesia for whom LMA management would be appropriate.
Key exclusion criteria (7 listed)
- with cervical spine disease
- expected difficult airway
- upper airway abnormalities
- body mass index (BMI) more than 35 kg/m2
- high risk of aspiration (hiatus hernia, gastro-oesophageal reflux disease and starvation)
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 |
|---|---|---|
| Cricoid pressureCricoid pressure will be applied during LMA ProSeal insertion. | Other | Cricoid pressure group |
| Paratracheal pressurePratracheal pressure will be applied during LMA ProSeal insertion. | Other | Paratracheal pressure group |
Primary outcome
Duration of insertion
Time frame: During intubation procedure
The time required for placement will be defined as the time from receipt of the LMA ProSeal to detection of the square waveform on capnography and will be calculated by summing the time taken for each attempt.
4 secondary outcomes
Sensation of resistance during inserting of LMA ProSeal
Time frame: During intubation procedure
Anatomical location of the LMA ProSeal in the larynx and accuracy of insertion site.
Time frame: 1 minutes after intubation
Tidal volume and peak inspiratory pressure with or without each maneuver after LMA ProSeal insertion.
Time frame: 2 minutes after intubation
Oropharyngeal leak pressure
Time frame: 5 minutes after induction of general anesthesia
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 Jan 2025.
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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.
Muhammet Korkusuz, MD principal investigator
Karamanoglu Mehmetbey University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cricoid pressure and Paratracheal pressure in people with Airway Management, run by Karaman 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 1 inclusion and 7 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 Jan 2025. 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. Some participants in this study may receive a placebo. 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?
Duration of insertion (time frame: During intubation procedure). 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 3 Jan 2025.