Airway AspirationLMANCT03903679
Is Endotracheal Tube Use Mandatory in Patients Undergoing Nasal Septum Surgery?
A study testing Laryngeal mask airway and Endotracheal tube in people with Airway Aspiration and Airway Complication of Anesthesia, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
The efficacy of supraglottic airway device use in many surgeries has been shown. Due to concerns such as tracheal blood leakage and vocal cord contamination in nasal septum surgery, there are doubts about the use of laryngeal mask airway among anesthesiologists. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Airway Aspiration, Airway Complication of Anesthesia
- What is being tested?
- Laryngeal mask airway and Endotracheal tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Apr 2019to 8 Jun 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years old,
- American Society of Anesthesiologists I-II
- Patients with elective nasal septum surgery.
- Patients who agreed to participate with informed consent form.
Who cannot join
- Under 18 years,
- Over 65 years,
- American Society of Anesthesiologists III-IV,
- Patients with severe respiratory, hepatic or renal dysfunction,
- Patients with history of allergy to anesthesia medications
- Modified mallampati grade 4,
- Thyromental distance <65 mm,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Inonu University Medical Faculty
Malatya, 44090
About this study
Official title: Is Endotracheal Tube Use Mandatory in Patients Undergoing Nasal Septum Surgery? Randomized, Controlled, Prospective Clinical Trial
The efficacy of supraglottic airway device use in many surgeries has been shown. Due to concerns such as tracheal blood leakage and vocal cord contamination in nasal septum surgery, there are doubts about the use of laryngeal mask airway among anesthesiologists.
The primary purpose of this study is; the aim of this study was to evaluate the tracheal blood leak with a flexible fiberoptic endoscope in patients who underwent nasal septum surgery and continued airway patency via laryngeal mask airway or endotracheal tube. Secondly, oropharyngeal leak pressure, hemodynamic response, airway reflexes (laryngospasm, bronchospasm, cough, desaturation), postoperative nausea, vomiting, sore throat, hoarseness and difficulty in swallowing will be evaluated.
Read the detailed description
Airway management is one of the main issue of anesthesia practice. The use of endotracheal tubes has been accepted as the standard method for many years. High pressure and long-term use of cuffed tubes related to mucosal hypoperfusion and submucosal stenosis are important. The laryngeal mask airway is produced in the 1980s and considered as a supraglottic airway used to provide airway clearance in short-term surgical procedures. The laryngeal mask airways have recently found to use in many general anesthesia applications as a minimally invasive airway method and continue to be used increasingly. More appropriate supraglottic airway vehicles with different characteristics in terms of efficacy and side effects are being developed.
Laryngeal mask airway-Supreme™ is latex-free, semi-rigid, elliptical and anatomical shape due to the fingers in the mouth of the patient easily and quickly without inserting the new generation laryngeal mask airways. Designed to provide higher sealing pressures than the laryngeal mask airway-classic. In addition, the presence of a gastric canal for gastric tube passage is another important advantage.
The efficacy of supraglottic airway device use in many surgeries has been shown. Due to concerns such as tracheal blood leakage and vocal cord contamination in nasal septum surgery, there are doubts about the use of laryngeal mask airway among anesthesiologists.
The primary purpose of this study is; the aim of this study was to evaluate the tracheal blood leak with a flexible fiberoptic endoscope in patients who underwent nasal septum surgery and continued airway patency via laryngeal mask airway or endotracheal tube. Secondly, oropharyngeal leak pressure, hemodynamic response, airway reflexes (laryngospasm, bronchospasm, cough, desaturation), postoperative nausea, vomiting, sore throat, hoarseness and difficulty in swallowing will be evaluated.
- Being tested
- Laryngeal mask airway, Endotracheal tube
- Keywords
- Airway management, Septal surgery, Laryngeal mask airway, Endotracheal tube, Presence of tracheal blood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laryngeal mask airwayDevice
Patients will be maintained with laryngeal mask airway during the septal surgery.
Endotracheal tubeDevice
Patients will be maintained with endotracheal tube during the septal surgery.
| Study group | Role | What they receive |
|---|---|---|
| Laryngeal mask airway | Active comparator | Patients will be maintained with laryngeal mask airway supreme during the septal surgery. Receives: Device: Laryngeal mask airway |
| Endotracheal tube | Sham comparator | Patients will be maintained with endotracheal tube during the septal surgery. Receives: Device: Endotracheal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of blood in trachea
Presence of blood in trachea will be evaluated on a scale and it is defined as the level of presence of blood on glottis-trachea and distal trachea. (1 = no, 2 = mild, 3 = moderate, 4 = severe).
Measured: From the time 2minutes after the septal surgery to the time of extubation
Secondary outcomes (2)
Sore-throat
Sore-throat is defined as constant pain felt independently of swallowing. The evaluation was made with 0 ile10 numerical pain rating scale. According to numerical pain rating scale, sore throat score was evaluated as; 0-1 none, 2-4 between mild, 5-7 intermediate and 8-10 severe N
Measured: From the time 10 minutes after awakening from anesthesia to the time 24 hours postoperatively
Oropharyngeal leak pressure
Oropharyngeal leak pressures were measured while the head was in neutral position. The flowmeter oxygen current was set at 3 L/min and the expiratory valve was closed. When an investigator who did not know which type of airway device was placed, another researcher looked at the current pressure value from the aneroid manometer and confirmed that the pressure remained constant (pressure gauge stability test). This value was recorded as the value of Oropharyngeal leakage pressure. To prevent lung exposure to barotrauma, the expiratory valve was opened when the peak inspiratory pressure reached 40 pressure, and the test was terminated.
Measured: From the time 2 minutes after anesthesia induction to the correction of inserted device 5 minutes after anesthesia induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start5 Apr 2019
- Primary completion1 Jun 2019
- Study completion8 Jun 2019
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 Airway AspirationStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erol Karaaslan, Inonu University
- Investigators
- Erol Karaaslan, Asst. Prof., Principal investigator, Inonu University Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03903679
- Sponsor's protocol ID
- erolkaraaslan2
- Acronym
- LMA
- Status last verified
- Jun 2019
- First submitted
- 2 Apr 2019
- Last updated
- 25 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mao S, Du X, Ma J, Zhang G, Cui J. A comparison between laryngeal mask airway and endotracheal intubation for anaesthesia in adult patients undergoing NUSS procedure. J Thorac Dis. 2018 Jun;10(6):3216-3224. doi: 10.21037/jtd.2018.05.74.
PubMed 30069317Karaaslan E, Akbas S, Ozkan AS, Colak C, Begec Z. A comparison of laryngeal mask airway-supreme and endotracheal tube use with respect to airway protection in patients undergoing septoplasty: a randomized, single-blind, controlled clinical trial. BMC Anesthesiol. 2021 Jan 7;21(1):5. doi: 10.1186/s12871-020-01222-4.
PubMed 33407130
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Endotracheal Tube Use Mandatory in Patients Undergoing Nasal Septum Surgery? Randomized, Controlled, Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT03903679
- Acronym / sponsor ID
- LMA / erolkaraaslan2
- Keywords
- Airway management, Septal surgery, Laryngeal mask airway, Endotracheal tube, Presence of tracheal blood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 5 Apr 2019 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 8 Jun 2019 (actual)
- First posted
- 4 Apr 2019 (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 efficacy of supraglottic airway device use in many surgeries has been shown. Due to concerns such as tracheal blood leakage and vocal cord contamination in nasal septum surgery, there are doubts about the use of laryngeal mask airway among anesthesiologists.
The primary purpose of this study is; the aim of this study was to evaluate the tracheal blood leak with a flexible fiberoptic endoscope in patients who underwent nasal septum surgery and continued airway patency via laryngeal mask airway or endotracheal tube. Secondly, oropharyngeal leak pressure, hemodynamic response, airway reflexes (laryngospasm, bronchospasm, cough, desaturation), postoperative nausea, vomiting, sore throat, hoarseness and difficulty in swallowing will be evaluated.
Detailed description
Airway management is one of the main issue of anesthesia practice. The use of endotracheal tubes has been accepted as the standard method for many years. High pressure and long-term use of cuffed tubes related to mucosal hypoperfusion and submucosal stenosis are important. The laryngeal mask airway is produced in the 1980s and considered as a supraglottic airway used to provide airway clearance in short-term surgical procedures. The laryngeal mask airways have recently found to use in many general anesthesia applications as a minimally invasive airway method and continue to be used increasingly. More appropriate supraglottic airway vehicles with different characteristics in terms of efficacy and side effects are being developed.
Laryngeal mask airway-Supreme™ is latex-free, semi-rigid, elliptical and anatomical shape due to the fingers in the mouth of the patient easily and quickly without inserting the new generation laryngeal mask airways. Designed to provide higher sealing pressures than the laryngeal mask airway-classic. In addition, the presence of a gastric canal for gastric tube passage is another important advantage.
The efficacy of supraglottic airway device use in many surgeries has been shown. Due to concerns such as tracheal blood leakage and vocal cord contamination in nasal septum surgery, there are doubts about the use of laryngeal mask airway among anesthesiologists.
The primary purpose of this study is; the aim of this study was to evaluate the tracheal blood leak with a flexible fiberoptic endoscope in patients who underwent nasal septum surgery and continued airway patency via laryngeal mask airway or endotracheal tube. Secondly, oropharyngeal leak pressure, hemodynamic response, airway reflexes (laryngospasm, bronchospasm, cough, desaturation), postoperative nausea, vomiting, sore throat, hoarseness and difficulty in swallowing will be evaluated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laryngeal mask airway | Active comparator | Device: Laryngeal mask airwayPatients will be maintained with laryngeal mask airway supreme during the septal surgery. |
| Endotracheal tube | Sham comparator | Device: Endotracheal tubePatients will be maintained with endotracheal tube during the septal surgery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-65 years old,
- American Society of Anesthesiologists I-II
- Patients with elective nasal septum surgery.
- Patients who agreed to participate with informed consent form.
Key exclusion criteria (7 listed)
- Under 18 years,
- Over 65 years,
- American Society of Anesthesiologists III-IV,
- Patients with severe respiratory, hepatic or renal dysfunction,
- Patients with history of allergy to anesthesia medications
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 |
|---|---|---|
| Laryngeal mask airwayPatients will be maintained with laryngeal mask airway during the septal surgery. | Device | Laryngeal mask airway |
| Endotracheal tubePatients will be maintained with endotracheal tube during the septal surgery. | Device | Endotracheal tube |
Primary outcome
Presence of blood in trachea
Time frame: From the time 2minutes after the septal surgery to the time of extubation
Presence of blood in trachea will be evaluated on a scale and it is defined as the level of presence of blood on glottis-trachea and distal trachea. (1 = no, 2 = mild, 3 = moderate, 4 = severe).
2 secondary outcomes
Sore-throat
Time frame: From the time 10 minutes after awakening from anesthesia to the time 24 hours postoperatively
Oropharyngeal leak pressure
Time frame: From the time 2 minutes after anesthesia induction to the correction of inserted device 5 minutes after anesthesia induction
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 25 Jun 2019.
- Background: PubMed 30069317Mao S, Du X, Ma J, Zhang G, Cui J. A comparison between laryngeal mask airway and endotracheal intubation for anaesthesia in adult patients undergoing NUSS procedure. J Thorac Dis. 2018 Jun;10(6):3216-3224. doi: 10.21037/jtd.2018.05.74.
- Derived from this study: PubMed 33407130Karaaslan E, Akbas S, Ozkan AS, Colak C, Begec Z. A comparison of laryngeal mask airway-supreme and endotracheal tube use with respect to airway protection in patients undergoing septoplasty: a randomized, single-blind, controlled clinical trial. BMC Anesthesiol. 2021 Jan 7;21(1):5. doi: 10.1186/s12871-020-01222-4.
- 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.
Erol Karaaslan, Asst. Prof. principal investigator
Inonu University Medical Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laryngeal mask airway and Endotracheal tube in people with Airway Aspiration and Airway Complication of Anesthesia, run by Inonu 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 4 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 25 Jun 2019. 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?
Presence of blood in trachea (time frame: From the time 2minutes after the septal surgery to the time of extubation). 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 NCT03903679, 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 25 Jun 2019.