Comparison of Airway Management Techniques in Functional Endoscopic Sinus SurgeryNCT07548866
Comparison of Laryngeal Mask and Tracheal Intubation With and Without Topical Lidocaine Application
An observational study of Comparison of Airway Management Techniques in Functional Endoscopic Sinus Surgery and Rhinosinusitis With Polyps, run by St. Petersburg State Pavlov Medical University at 1 site in Russia.
Trial summary
The study aims to identify the advantages and disadvantages of each of the three methods of airway management during FESS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Comparison of Airway Management Techniques in Functional Endoscopic Sinus Surgery, Rhinosinusitis With Polyps, Deviated Nasal Septum
- What is being tested?
- anesthesia of the respiratory tract with lidocaine, tracheal intubation and laryngeal mask placement
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteRussia
- Study dates
- 1 Apr 2026to 1 Feb 2027
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients who underwent FESS under general anesthesia
Who may be able to join
- general anesthesia during fess
Who cannot join
- history of mental and neurological diseases
Trial locations and contacts
1 site in 1 country.
Russia1 site
Pavlov First Saint Petersburg State Medical University
Saint Petersburg, 197022
About this study
The study aims to identify the advantages and disadvantages of each of the three methods of airway management during FESS.
- Conditions
- Comparison of Airway Management Techniques in Functional Endoscopic Sinus Surgery, Rhinosinusitis With Polyps, Deviated Nasal Septum, Osteoma of the Paranasal Sinuses
- Being tested
- anesthesia of the respiratory tract with lidocaine, tracheal intubation, laryngeal mask placement
- Keywords
- Laryngeal mask airway, Tracheal intubation, Airway anesthesia, FESS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anesthesia of the respiratory tract with lidocaineDrug
administration of 4% lidocaine during tracheal intubation
tracheal intubationDevice
intraoperative tracheal intubation
laryngeal mask placementDevice
intraoperative placement of a laryngeal mask
| Study group | Role | What they receive |
|---|---|---|
| LMA (1) | the laryngeal mask was installed intraoperatively Receives: Device: laryngeal mask placement | |
| TI (2) | tracheal intubation was performed intraoperatively Receives: Device: tracheal intubation | |
| TIL (3) | intraoperative tracheal intubation and respiratory tract anesthesia were performed Receives: Drug: anesthesia of the respiratory tract with lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
cough severity and frequencies
Coughing was scored as mild (single cough), moderate (>1 episode of un- sustained coughing lasting 5 seconds), or severe (sustained, >5 seconds, bouts of coughing). Target values - mild cough.
Measured: 15 minutes after waking up
Secondary outcomes (2)
Richmond agitation-sedation scale (RASS)
A 10-level scale ranges from +4 (extreme aggression) to -5 (no arousal at all). The target level for most patients is 0 (quiet alertness) or mild sedation (-1/-2).
Measured: 15 minutes after waking up
The Ramsay scale
The Ramsay scale consists of 6 levels. Level 1: the patient is agitated and restless. Level 6: the patient is asleep and unresponsive. Target values for the study are levels 2-3.
Measured: 15 minutes after waking up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start1 Apr 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comparison of Airway Management Techniques in Functional Endoscopic Sinus SurgeryStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Petersburg State Pavlov Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vladimir Pavlov, St. Petersburg State Pavlov Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07548866
- Sponsor's protocol ID
- LM$TI
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: only statistical processing of an unnamed data array is planned
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Laryngeal Mask and Tracheal Intubation With and Without Topical Lidocaine Application
- ClinicalTrials.gov ID
- NCT07548866
- Acronym / sponsor ID
- LM$TI
- Conditions
- Comparison of Airway Management Techniques in Functional Endoscopic Sinus Surgery, Rhinosinusitis With Polyps, Deviated Nasal Septum, Osteoma of the Paranasal Sinuses
- Keywords
- Laryngeal mask airway, Tracheal intubation, Airway anesthesia, FESS
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- St. Petersburg State Pavlov Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 23 Apr 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.
The study aims to identify the advantages and disadvantages of each of the three methods of airway management during FESS.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LMA (1) | – | Device: laryngeal mask placementthe laryngeal mask was installed intraoperatively |
| TI (2) | – | Device: tracheal intubationtracheal intubation was performed intraoperatively |
| TIL (3) | – | Drug: anesthesia of the respiratory tract with lidocaineintraoperative tracheal intubation and respiratory tract anesthesia were performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients who underwent FESS under general anesthesia
Key inclusion criteria (1 listed)
- general anesthesia during fess
Key exclusion criteria (1 listed)
- history of mental and neurological diseases
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 |
|---|---|---|
| anesthesia of the respiratory tract with lidocaineadministration of 4% lidocaine during tracheal intubation | Drug | TIL (3) |
| tracheal intubationintraoperative tracheal intubation | Device | TI (2) |
| laryngeal mask placementintraoperative placement of a laryngeal mask | Device | LMA (1) |
Primary outcome
cough severity and frequencies
Time frame: 15 minutes after waking up
Coughing was scored as mild (single cough), moderate (>1 episode of un- sustained coughing lasting 5 seconds), or severe (sustained, >5 seconds, bouts of coughing). Target values - mild cough.
2 secondary outcomes
Richmond agitation-sedation scale (RASS)
Time frame: 15 minutes after waking up
The Ramsay scale
Time frame: 15 minutes after waking up
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 30 Apr 2026.
- Individual participant dataSharing planned: No. only statistical processing of an unnamed data array is planned
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?
An observational study of Comparison of Airway Management Techniques in Functional Endoscopic Sinus Surgery and Rhinosinusitis With Polyps, run by St. Petersburg State Pavlov Medical University at 1 site in Russia.
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 1 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 30 Apr 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 Russia. 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?
cough severity and frequencies (time frame: 15 minutes after waking up). 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 30 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.