All the Pediatric Patients Needed Intubation for SurgeryNCT02069444
Comparison of the Effects of Truview Laryngoscopy and Macintosh Larygonscopy on Intubation Difficulty Score, Intubation Duration and Intubation Quality in Pediatric Patients Between 2-12 Years
An observational study of All the Pediatric Patients Needed Intubation for Surgery, run by Ankara University at 2 sites in Turkey (Türkiye).
Trial summary
For endotracheal entubation in children mostly Miller and Macintosh blades have been used. On the other hand Truview EVO2 laringoscopes can maintain a better laryngeal view without having a direct sight of the airway and without having to align oral, pharyngeal, and tracheal axes. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- All the Pediatric Patients Needed Intubation for Surgery
- What is being tested?
- Macintosh laryngoscope and Truview EVO2 laryngoscope
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- Jan 2012to Oct 2012
- How long will I take part?
- 1 Day
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: pediatric patients undergoing surgery which needs intubation
Who may be able to join
- aged 2-12 pediatric patients
Who cannot join
- any allergy
- difficult airway history
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Ankara University
Ankara, 06550
Ankara University, Pediatric Surgery
Ankara
About this study
For endotracheal entubation in children mostly Miller and Macintosh blades have been used. On the other hand Truview EVO2 laringoscopes can maintain a better laryngeal view without having a direct sight of the airway and without having to align oral, pharyngeal, and tracheal axes. The aim of this study is to compare the Truview EVO2 laryngoscope and Macintosh laryngoscope in terms of intubation difficulty score, time to intubation and intubation quality score.
- Being tested
- Macintosh laryngoscope, Truview EVO2 laryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macintosh laryngoscopeProcedure or surgery
intubation criterias withMacintosh laryngoscopein pediatric patients
Truview EVO2 laryngoscopeProcedure or surgery
intubation criterias with Truview EVO2 laryngoscope in pediatric patients
| Study group | Role | What they receive |
|---|---|---|
| Truview EVO2 laryngoscope | patients intubated withTruview EVO2 laryngoscope Receives: Procedure: Truview EVO2 laryngoscope | |
| Macintosh laryngoscope | patients intubated with Macintosh laryngoscope Receives: Procedure: Macintosh laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
ease laryngoscopy in children
Measured: during laryngoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2014 (estimated)
- Study startJan 2012
- Primary completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for All the Pediatric Patients Needed Intubation for SurgeryStudies of the same condition, open and under way.
- More trials run by Ankara 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-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CIGDEM YILDIRIM GUCLU, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02069444
- Sponsor's protocol ID
- 2-12
- Status last verified
- Feb 2014
- First submitted
- 20 Feb 2014
- Last updated
- 24 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Truview Laryngoscopy and Macintosh Larygonscopy on Intubation Difficulty Score, Intubation Duration and Intubation Quality in Pediatric Patients Between 2-12 Years
- ClinicalTrials.gov ID
- NCT02069444
- Acronym / sponsor ID
- 2-12
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Oct 2012 (actual)
- First posted
- 24 Feb 2014 (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.
For endotracheal entubation in children mostly Miller and Macintosh blades have been used. On the other hand Truview EVO2 laringoscopes can maintain a better laryngeal view without having a direct sight of the airway and without having to align oral, pharyngeal, and tracheal axes. The aim of this study is to compare the Truview EVO2 laryngoscope and Macintosh laryngoscope in terms of intubation difficulty score, time to intubation and intubation quality score.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Truview EVO2 laryngoscope | – | Procedure: Truview EVO2 laryngoscopepatients intubated withTruview EVO2 laryngoscope |
| Macintosh laryngoscope | – | Procedure: Macintosh laryngoscopepatients intubated with Macintosh laryngoscope |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- pediatric patients undergoing surgery which needs intubation
Key inclusion criteria (1 listed)
- aged 2-12 pediatric patients
Key exclusion criteria (2 listed)
- any allergy
- difficult airway history
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 |
|---|---|---|
| Macintosh laryngoscopeintubation criterias withMacintosh laryngoscopein pediatric patients | Procedure or surgery | Macintosh laryngoscope |
| Truview EVO2 laryngoscopeintubation criterias with Truview EVO2 laryngoscope in pediatric patients | Procedure or surgery | Truview EVO2 laryngoscope |
Primary outcome
ease laryngoscopy in children
Time frame: during laryngoscopy
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 24 Feb 2014.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of All the Pediatric Patients Needed Intubation for Surgery, run by Ankara University at 2 sites 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 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 24 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
ease laryngoscopy in children (time frame: during laryngoscopy). 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 24 Feb 2014.