The Device Placement TimesNCT06121895
Evaluation of Differences in Video Laryngeal Mask Airway and Fastrack Laryngeal Mask
An observational study of The Device Placement Times and Intubation Times, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
In our study, patients who are intubated using VLM and Fastrack LMA for intubation purposes will be included. The placement times, intubation times, and the number of failed attempts for both devices will be recorded. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- The Device Placement Times, Intubation Times, Postoperative Complications
- What is being tested?
- Video Laryngeal Mask and Fastrack Laryngeal Mask
- How many people
- 101 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Dec 2023to 15 Aug 2024
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Surgical patients undergoing elective surgery and intubated under general anesthesia.
Who may be able to join
- Individuals between the ages of 18 and 80.
- Patients with ASA (American Society of Anesthesiologists) scores I, II, or III.
- Patients undergoing surgery under general anesthesia in the operating room.
Who cannot join
- Patients under 18 years old or over 80 years old.
- Patients who refuse to participate in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Ankara, Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle, 06170
About this study
Official title: Evaluation of Differences in Placement Success and Postoperative Complications Between Video Laryngeal Mask Airway and Fastrack Laryngeal Mask
In our study, patients who are intubated using VLM and Fastrack LMA for intubation purposes will be included. The placement times, intubation times, and the number of failed attempts for both devices will be recorded. Additionally, postoperative complications (sore throat, hoarseness, nausea-vomiting, additional antiemetic medication requirements, etc.) will be monitored and recorded.
Read the detailed description
The 2015 Difficult Airway Society guidelines specify that in cases where an unexpectedly difficult airway is encountered, and the initial intubation attempt is unsuccessful, the insertion of a supraglottic airway device (SAD) is recommended to maintain ventilation and oxygenation, followed by tracheal intubation through the SAD. SAD has been designated as a rescue airway device in difficult airway algorithms and resuscitation guidelines to "buy time." Additionally, SAD is used to maintain airway and anesthesia in surgeries that do not require intubation.
The Video Laryngeal Mask (VLM) is a newly developed type of SAD. With VLM, direct visualization of the glottis is achieved immediately after SAD placement. VLM has a channel that allows for endotracheal tube passage for intubation purposes and provides direct visualization. The Fastrack LMA, on the other hand, possesses all the ventilation features of classic SADs but is designed for blind or fiberoptic-guided tracheal intubations. These devices are used as rescue devices in cases of limited neck extension and difficult airway situations. Both devices are routinely used for ventilation and intubation purposes in patients. The use of these two devices is preferred in patients where neck extension is undesirable or neck movements are restricted for intubation purposes.
In our study, patients who are intubated using VLM and Fastrack LMA for intubation purposes will be included. The placement times, intubation times, and the number of failed attempts for both devices will be recorded. Additionally, postoperative complications (sore throat, hoarseness, nausea-vomiting, additional antiemetic medication requirements, etc.) will be monitored and recorded.
- Being tested
- Video Laryngeal Mask, Fastrack Laryngeal Mask
- Keywords
- Fastrack Laryngeal Mask, Video Laryngeal Mask
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video Laryngeal MaskOther
Patients who are intubated using Video Laryngeal Mask for intubation purposes will be included.
Fastrack Laryngeal MaskOther
Patients who are intubated using Fastrack Laryngeal Mask for intubation purposes will be included.
| Study group | Role | What they receive |
|---|---|---|
| Video Laryngeal Mask | Patients who are intubated using Video Laryngeal Mask for intubation purposes will be included. Receives: Other: Video Laryngeal Mask | |
| Fastrack Laryngeal Mask | Patients who are intubated using Fastrack Laryngeal Mask for intubation purposes will be included. Receives: Other: Fastrack Laryngeal Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laryngeal Mask Placement times(minute)
Laryngeal Mask Placement times(minute)
Measured: 3 minutes after induction of anesthesia
Intubation times
Intubation times
Measured: 3 minutes after induction of anesthesia
Number of failed attempts
Number of failed attempts
Measured: 3 minutes after induction of anesthesia
Secondary outcomes (4)
Sore throat
Postoperative complications
Measured: 0-2-4-8-12-24 hours postoperatively
Hoarseness
Postoperative complications
Measured: 0-2-4-8-12-24 hours postoperatively
Nausea-vomiting
Postoperative complications
Measured: 0-2-4-8-12-24 hours postoperatively
Need for additional antiemetic medication
Postoperative complications
Measured: 0-2-4-8-12-24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start10 Dec 2023
- Primary completion1 Apr 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for The Device Placement TimesStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yusuf Özgüner, Ankara Etlik City Hospital
- Investigators
- Yusuf Ozguner, Principal investigator, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06121895
- Sponsor's protocol ID
- AnkaraEtlikYusufOzguner006
- Status last verified
- Nov 2024
- First submitted
- 29 Oct 2023
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Frerk C, Mitchell VS, McNarry AF, Mendonca C, Bhagrath R, Patel A, O'Sullivan EP, Woodall NM, Ahmad I; Difficult Airway Society intubation guidelines working group. Difficult Airway Society 2015 guidelines for management of unanticipated difficult intubation in adults. Br J Anaesth. 2015 Dec;115(6):827-48. doi: 10.1093/bja/aev371. Epub 2015 Nov 10.
PubMed 26556848Van Zundert AAJ, Gatt SP, Van Zundert TCRV, Kumar CM, Pandit JJ. Features of new vision-incorporated third-generation video laryngeal mask airways. J Clin Monit Comput. 2022 Aug;36(4):921-928. doi: 10.1007/s10877-021-00780-3. Epub 2021 Dec 17.
PubMed 34919170Ferson DZ, Rosenblatt WH, Johansen MJ, Osborn I, Ovassapian A. Use of the intubating LMA-Fastrach in 254 patients with difficult-to-manage airways. Anesthesiology. 2001 Nov;95(5):1175-81. doi: 10.1097/00000542-200111000-00022.
PubMed 11684987Ozguner Y, Ozagar UC, Kina SF, Sezgi A, Altinsoy S, Ergil J. Comparison of sacovlm video laryngeal mask-guided intubation and fastrach combined with flexible bronchoscopy-guided intubation -a prospective study. BMC Anesthesiol. 2025 Jul 1;25(1):315. doi: 10.1186/s12871-025-03172-1.
PubMed 40596865
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Differences in Placement Success and Postoperative Complications Between Video Laryngeal Mask Airway and Fastrack Laryngeal Mask
- ClinicalTrials.gov ID
- NCT06121895
- Acronym / sponsor ID
- AnkaraEtlikYusufOzguner006
- Keywords
- Fastrack Laryngeal Mask, Video Laryngeal Mask
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 10 Dec 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 8 Nov 2023 (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.
In our study, patients who are intubated using VLM and Fastrack LMA for intubation purposes will be included. The placement times, intubation times, and the number of failed attempts for both devices will be recorded. Additionally, postoperative complications (sore throat, hoarseness, nausea-vomiting, additional antiemetic medication requirements, etc.) will be monitored and recorded.
Detailed description
The 2015 Difficult Airway Society guidelines specify that in cases where an unexpectedly difficult airway is encountered, and the initial intubation attempt is unsuccessful, the insertion of a supraglottic airway device (SAD) is recommended to maintain ventilation and oxygenation, followed by tracheal intubation through the SAD. SAD has been designated as a rescue airway device in difficult airway algorithms and resuscitation guidelines to "buy time." Additionally, SAD is used to maintain airway and anesthesia in surgeries that do not require intubation.
The Video Laryngeal Mask (VLM) is a newly developed type of SAD. With VLM, direct visualization of the glottis is achieved immediately after SAD placement. VLM has a channel that allows for endotracheal tube passage for intubation purposes and provides direct visualization. The Fastrack LMA, on the other hand, possesses all the ventilation features of classic SADs but is designed for blind or fiberoptic-guided tracheal intubations. These devices are used as rescue devices in cases of limited neck extension and difficult airway situations. Both devices are routinely used for ventilation and intubation purposes in patients. The use of these two devices is preferred in patients where neck extension is undesirable or neck movements are restricted for intubation purposes.
In our study, patients who are intubated using VLM and Fastrack LMA for intubation purposes will be included. The placement times, intubation times, and the number of failed attempts for both devices will be recorded. Additionally, postoperative complications (sore throat, hoarseness, nausea-vomiting, additional antiemetic medication requirements, etc.) will be monitored and recorded.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video Laryngeal Mask | – | Other: Video Laryngeal MaskPatients who are intubated using Video Laryngeal Mask for intubation purposes will be included. |
| Fastrack Laryngeal Mask | – | Other: Fastrack Laryngeal MaskPatients who are intubated using Fastrack Laryngeal Mask for intubation purposes will be included. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Surgical patients undergoing elective surgery and intubated under general anesthesia.
Key inclusion criteria (3 listed)
- Individuals between the ages of 18 and 80.
- Patients with ASA (American Society of Anesthesiologists) scores I, II, or III.
- Patients undergoing surgery under general anesthesia in the operating room.
Key exclusion criteria (2 listed)
- Patients under 18 years old or over 80 years old.
- Patients who refuse to participate in the study.
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 |
|---|---|---|
| Video Laryngeal MaskPatients who are intubated using Video Laryngeal Mask for intubation purposes will be included. | Other | Video Laryngeal Mask |
| Fastrack Laryngeal MaskPatients who are intubated using Fastrack Laryngeal Mask for intubation purposes will be included. | Other | Fastrack Laryngeal Mask |
Primary outcome
Laryngeal Mask Placement times(minute)
Time frame: 3 minutes after induction of anesthesia
Laryngeal Mask Placement times(minute)
Intubation times
Time frame: 3 minutes after induction of anesthesia
Intubation times
Number of failed attempts
Time frame: 3 minutes after induction of anesthesia
Number of failed attempts
4 secondary outcomes
Sore throat
Time frame: 0-2-4-8-12-24 hours postoperatively
Hoarseness
Time frame: 0-2-4-8-12-24 hours postoperatively
Nausea-vomiting
Time frame: 0-2-4-8-12-24 hours postoperatively
Need for additional antiemetic medication
Time frame: 0-2-4-8-12-24 hours postoperatively
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 4 Dec 2024.
- Results publication: PubMed 26556848Frerk C, Mitchell VS, McNarry AF, Mendonca C, Bhagrath R, Patel A, O'Sullivan EP, Woodall NM, Ahmad I; Difficult Airway Society intubation guidelines working group. Difficult Airway Society 2015 guidelines for management of unanticipated difficult intubation in adults. Br J Anaesth. 2015 Dec;115(6):827-48. doi: 10.1093/bja/aev371. Epub 2015 Nov 10.
- Results publication: PubMed 34919170Van Zundert AAJ, Gatt SP, Van Zundert TCRV, Kumar CM, Pandit JJ. Features of new vision-incorporated third-generation video laryngeal mask airways. J Clin Monit Comput. 2022 Aug;36(4):921-928. doi: 10.1007/s10877-021-00780-3. Epub 2021 Dec 17.
- Results publication: PubMed 11684987Ferson DZ, Rosenblatt WH, Johansen MJ, Osborn I, Ovassapian A. Use of the intubating LMA-Fastrach in 254 patients with difficult-to-manage airways. Anesthesiology. 2001 Nov;95(5):1175-81. doi: 10.1097/00000542-200111000-00022.
- Derived from this study: PubMed 40596865Ozguner Y, Ozagar UC, Kina SF, Sezgi A, Altinsoy S, Ergil J. Comparison of sacovlm video laryngeal mask-guided intubation and fastrach combined with flexible bronchoscopy-guided intubation -a prospective study. BMC Anesthesiol. 2025 Jul 1;25(1):315. doi: 10.1186/s12871-025-03172-1.
- 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.
Yusuf Ozguner principal investigator
Ankara Etlik City Hospital
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 The Device Placement Times and Intubation Times, run by Ankara Etlik City 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 2 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 4 Dec 2024. 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?
Laryngeal Mask Placement times(minute) (time frame: 3 minutes after induction of anesthesia). The study lists 3 primary outcomes in all. 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 NCT06121895, which also lists 4 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 4 Dec 2024.