the Hemodynamic ParametersNCT01917565
The Use of Airtraq Laryngoscope Versus Macintosh Laryngoscope and Fiberoptic Bronchoscope by Experienced Anesthesiologists
An observational study of the Hemodynamic Parameters and Intubation Times, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The investigators hypothesize that when used by experienced anesthesiologists, Airtraq laryngoscope will increase the first-attempt success rate with shorter intubation times and more stable hemodynamic parameters. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- the Hemodynamic Parameters, Intubation Times, Complications During and After Intubation
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2013to Mar 2014
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing surgery under general anesthesia
Who may be able to join
- ASA physical status classification of 1 or 2, undergoing elective surgery under general anesthesia and requiring endotracheal intubation
Who cannot join
- Patients with ASA 3 or 4, Mallampati score of 3 or 4, history of difficult intubation, thyromental distance less than 6.5 cm, sternomental distance less than 12.5 cm, body mass index higher than 35 kg/m2 and limited neck mobility
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Anesthesiology, Marmara University School of Medicine
Istanbul, 34734
Kemal T Saracoglu, Assist. Prof. M.D., +902166570606, saracoglukt@gmail.com
Tumay Umuroglu, Assoc. Prof. M.D.
About this study
The investigators hypothesize that when used by experienced anesthesiologists, Airtraq laryngoscope will increase the first-attempt success rate with shorter intubation times and more stable hemodynamic parameters.
Read the detailed description
The special design of the Airtraq allows the direct exposure of the glottic opening without the necessity of optimal alignment of the oral, pharyngeal and laryngeal axes. The results of the meta-analysis comparing the Airtraq with the conventional Macintosh laryngoscope concluded that the use of Airtraq results in a rapid and accurate intubation. The main advantages of the fiberoptic bronchoscope are minimal airway trauma and minimal deterioration of the hemodynamic parameters.
The purpose of this study is to compare the hemodynamic parameters, intubation times, complications during and after intubation and postoperative sore throat scores of the patients having normal airway anatomy, intubated with Airtraq, Macintosh laryngoscope or fiberoptic bronchoscope, by experienced anesthesiologists.
- Keywords
- airway management, laryngoscope, Airtraq, Macintosh laryngoscope, fiberoptic bronchoscope, intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Airtraq laryngoscope group | The patients who will be intubated by using Airtraq laryngoscope | |
| Macintosh laryngoscope group | The patients who will be intubated by using Macintosh laryngoscope | |
| Fiberoptic bronchoscope group | The patients who will be intubated by using Fiberoptic bronchoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
The required time to successful tracheal intubation
The primary outcome variable is the required time to successful tracheal intubation
Measured: six months
Secondary outcomes (1)
The first-attempt success rate of tracheal intubation
The secondary outcome variable is the first-attempt success rate of tracheal intubation
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionFeb 2014 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Hemodynamic ParametersStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, tolga saracoglu, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01917565
- Sponsor's protocol ID
- 09.2011.0127
- Status last verified
- Aug 2013
- First submitted
- 2 Aug 2013
- Last updated
- 6 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Airtraq Laryngoscope Versus Macintosh Laryngoscope and Fiberoptic Bronchoscope by Experienced Anesthesiologists
- ClinicalTrials.gov ID
- NCT01917565
- Acronym / sponsor ID
- 09.2011.0127
- Keywords
- airway management, laryngoscope, Airtraq, Macintosh laryngoscope, fiberoptic bronchoscope, intubation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 6 Aug 2013 (estimated)
- 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 investigators hypothesize that when used by experienced anesthesiologists, Airtraq laryngoscope will increase the first-attempt success rate with shorter intubation times and more stable hemodynamic parameters.
Detailed description
The special design of the Airtraq allows the direct exposure of the glottic opening without the necessity of optimal alignment of the oral, pharyngeal and laryngeal axes. The results of the meta-analysis comparing the Airtraq with the conventional Macintosh laryngoscope concluded that the use of Airtraq results in a rapid and accurate intubation. The main advantages of the fiberoptic bronchoscope are minimal airway trauma and minimal deterioration of the hemodynamic parameters.
The purpose of this study is to compare the hemodynamic parameters, intubation times, complications during and after intubation and postoperative sore throat scores of the patients having normal airway anatomy, intubated with Airtraq, Macintosh laryngoscope or fiberoptic bronchoscope, by experienced anesthesiologists.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Airtraq laryngoscope group | – | –The patients who will be intubated by using Airtraq laryngoscope |
| Macintosh laryngoscope group | – | –The patients who will be intubated by using Macintosh laryngoscope |
| Fiberoptic bronchoscope group | – | –The patients who will be intubated by using Fiberoptic bronchoscope |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing surgery under general anesthesia
Key inclusion criteria (1 listed)
- ASA physical status classification of 1 or 2, undergoing elective surgery under general anesthesia and requiring endotracheal intubation
Key exclusion criteria (1 listed)
- Patients with ASA 3 or 4, Mallampati score of 3 or 4, history of difficult intubation, thyromental distance less than 6.5 cm, sternomental distance less than 12.5 cm, body mass index higher than 35 kg/m2 and limited neck mobility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The required time to successful tracheal intubation
Time frame: six months
The primary outcome variable is the required time to successful tracheal intubation
1 secondary outcome
The first-attempt success rate of tracheal intubation
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2013.
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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.
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 Hemodynamic Parameters and Intubation Times, run by Marmara 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 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: status not confirmed, as of the sponsor's last update on 6 Aug 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kemal T Saracoglu, Assist. Prof. M.D. (+902166570606, saracoglukt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The required time to successful tracheal intubation (time frame: six months). 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 6 Aug 2013.