AnesthesiologyNCT03326882
Glidescope Videolaryngoscope and Macintosh Laryngoscope in Children
A study testing Endotracheal intubation in people with Anesthesiology and Pediatrics, run by Sisli Hamidiye Etfal Training and Research Hospital.
Trial summary
The main objective of this study was to evaluate the intubation time of Glidescope compared with Macintoch laryngoscope in pediatric patients, ease of intubation, and cardiovascular changes during intubation. Read more about this study
- Who is it for?
- Ages 1 year to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesiology, Pediatrics
- What is being tested?
- Endotracheal intubation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Apr 2016
- 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 1 year to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- ASA physical status I-II patients,
- scheduled for elective surgery under general anesthesia with endotracheal intubation
Who cannot join
- risk of pulmonary aspiration,
- presence of difficult intubation,
- emergency surgery,
- cardiovascular disease,
- respiratuar disease,
- hemodynamic instability.
About this study
Official title: Comparison of Glidescope Videolaryngoscope and Macintosh Laryngoscope in Children Aged >1 Years
The main objective of this study was to evaluate the intubation time of Glidescope compared with Macintoch laryngoscope in pediatric patients, ease of intubation, and cardiovascular changes during intubation.
Read the detailed description
This was a prospective randomized clinical study to be performed in pediatric patients older than 1 years who are undergoing surgical procedures requiring endotracheal intubation. Time to endotracheal intubation was compared between patients intubated using a GlideScope® video laryngoscope, and those intubated by standard direct laryngoscopy. The main objective of this study was to evaluate the intubation time of Glidescope compared with Macintoch laryngoscope in pediatric patients, ease of intubation, and cardiovascular changes during intubation.
- Conditions
- Anesthesiology, Pediatrics
- Being tested
- Endotracheal intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endotracheal intubationDevice
Also called Glidescope video laryngoscope
| Study group | Role | What they receive |
|---|---|---|
| Glidescope | Active comparator | A device for endotracheal intubation Receives: Device: Endotracheal intubation |
| Macintosh laringoscope | Active comparator | A device for endotracheal intubation Receives: Device: Endotracheal intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Intubation
Time from laryngoscopy to intubation
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study startFeb 2016
- Primary completionMar 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiologyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Canan Tulay ISIL, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- Canan Tulay Isil, Study director, Sisli Hamidiye Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03326882
- Sponsor's protocol ID
- SEEAH
- Status last verified
- Oct 2017
- First submitted
- 24 Oct 2017
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: This kind of data can only be shared with additional governemental agreement.
Publications
Holm-Knudsen RJ, Rasmussen LS. Paediatric airway management: basic aspects. Acta Anaesthesiol Scand. 2009 Jan;53(1):1-9. doi: 10.1111/j.1399-6576.2008.01794.x.
PubMed 19128325
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Glidescope Videolaryngoscope and Macintosh Laryngoscope in Children Aged >1 Years
- ClinicalTrials.gov ID
- NCT03326882
- Acronym / sponsor ID
- SEEAH
- Conditions
- Anesthesiology, Pediatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 31 Oct 2017 (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 main objective of this study was to evaluate the intubation time of Glidescope compared with Macintoch laryngoscope in pediatric patients, ease of intubation, and cardiovascular changes during intubation.
Detailed description
This was a prospective randomized clinical study to be performed in pediatric patients older than 1 years who are undergoing surgical procedures requiring endotracheal intubation. Time to endotracheal intubation was compared between patients intubated using a GlideScope® video laryngoscope, and those intubated by standard direct laryngoscopy. The main objective of this study was to evaluate the intubation time of Glidescope compared with Macintoch laryngoscope in pediatric patients, ease of intubation, and cardiovascular changes during intubation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glidescope | Active comparator | Device: Endotracheal intubationA device for endotracheal intubation |
| Macintosh laringoscope | Active comparator | Device: Endotracheal intubationA device for endotracheal intubation |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- ASA physical status I-II patients,
- scheduled for elective surgery under general anesthesia with endotracheal intubation
Key exclusion criteria (6 listed)
- risk of pulmonary aspiration,
- presence of difficult intubation,
- emergency surgery,
- cardiovascular disease,
- respiratuar disease,
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 |
|---|---|---|
| Endotracheal intubationAlso: Glidescope video laryngoscope | Device | Glidescope, Macintosh laringoscope |
Primary outcome
Duration of Intubation
Time frame: Intraoperative
Time from laryngoscopy to intubation
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 31 Oct 2017.
- Background: PubMed 19128325Holm-Knudsen RJ, Rasmussen LS. Paediatric airway management: basic aspects. Acta Anaesthesiol Scand. 2009 Jan;53(1):1-9. doi: 10.1111/j.1399-6576.2008.01794.x.
- Individual participant dataSharing planned: No. This kind of data can only be shared with additional governemental agreement.
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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.
Canan Tulay Isil study director
Sisli Hamidiye Etfal Training and Research Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Endotracheal intubation in people with Anesthesiology and Pediatrics, run by Sisli Hamidiye Etfal Training and Research Hospital.
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 2 inclusion and 6 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 31 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Duration of Intubation (time frame: Intraoperative). 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 NCT03326882, which also lists 1 linked publication.
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 31 Oct 2017.