Tracheal Intubation MorbidityVideoscopyNCT03747250
Videolaryngoscopy vs. Direct Laryngoscopy for Elective Airway Management in Pediatric Anesthesia
A study testing Videolaryngoscopy and Direct laryngoscopy in people with Tracheal Intubation Morbidity, run by Brno University Hospital at 1 site in Czechia.
Trial summary
Videolaryngoscopy can lead to superior airway conditions and to the possible higher success compared to standard direct laryngoscopy. Patient will be randomized to the interventional group (videolaryngoscopy) and control group (direct laryngoscopy). Read more about this study
- Who is it for?
- Ages 29 days to 19 years
- Conditions the study is for
- Tracheal Intubation Morbidity
- What is being tested?
- Videolaryngoscopy and Direct laryngoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 501 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jan 2019to 28 Feb 2021
- 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 29 days to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric patients scheduled for elective surgery
- Planned tracheal intubation for airway management during surgery
- Signed informed consent
Who cannot join
- Emergency surgery
- Other airway management plan
- age outside the predefined limits
- Informed consent not signed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Videolaryngoscopy Versus Direct Laryngoscopy for Elective Airway Management in Pediatric Anesthesia: Randomized Controlled Trial
Videolaryngoscopy can lead to superior airway conditions and to the possible higher success compared to standard direct laryngoscopy. Patient will be randomized to the interventional group (videolaryngoscopy) and control group (direct laryngoscopy). The first attempt success rate, time to first end-tidal CO2 (ETCO2) wave, overall success rate, incidence of aspiration, bradycardia, desaturation a overall complications will be monitored.
Read the detailed description
Videolaryngoscopy is specialized equipment for airway management, where a camera located at the tip of the laryngoscope blade can visualize also structures that can´t be seen on direct laryngoscopy, co the operator can obtain superior view of aditus laryngis during intubation. Currently videolaryngoscopy is not routinely used for intubation and it is reserved for patients with difficult airway. The aim of the trial is to compare the elective use of videolaryngoscopy versus direct laryngoscopy for elective airway management (tracheal intubation). Patients after informed consent approval will be randomized to the interventional group (videolaryngoscopy) and control group (laryngoscopy). The randomization will be managed by the Institute of Biostatistics and Analyses by the Faculty of medicine, Masaryk university. The primary aim will be the first intubation attempt success rate, the secondary aims will be time to successful intubation (time to first ETCO2 wave), overall success rate, number of intubation attempts, incidence of aspiration, desaturation and incidence of overall complications in all operators, in trainees, residents (5-10 years of practice), consultants (10-15 years of clinical practice) and consultants with over 15 years of clinical practice.
- Conditions
- Tracheal Intubation Morbidity
- Being tested
- Videolaryngoscopy, Direct laryngoscopy
- Keywords
- Videolaryngoscopy, Laryngoscopy, Tracheal intubation, Success rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideolaryngoscopyDevice
In experimental group (interventional group), patients will be intubated with the videolaryngoscope
Direct laryngoscopyDevice
In control group (active comparator group), patients will be intubated with the direct laryngoscope
| Study group | Role | What they receive |
|---|---|---|
| Videolaryngoscopy | Experimental | Pediatric patients undergoing elective surgery with planned tracheal intubation for airway management. The tracheal intubation will be performed with the use of videolaryngoscope Receives: Device: Videolaryngoscopy |
| Direct laryngoscopy | Active comparator | Pediatric patients undergoing elective surgery with planned tracheal intubation for airway management. The tracheal intubation will be performed with the use of direct laryngoscopy Receives: Device: Direct laryngoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
First intubation attempt success rate
Success rate of the first intubation attempt
Measured: Intraoperatively
Secondary outcomes (4)
Time for successful intubation
Time need for intubation from decision to intubate to first end-tidal CO2 wave
Measured: Intraoperatively
Overall intubation success rate
Success rate fot intubation
Measured: Intraoperatively
Laryngeal view
Laryngeal view scored by Cormack-Lehane grading system
Measured: Intraoperatively
Complications
Incidence of associated complications during anesthesia induction - desaturation, bradycardia
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start1 Jan 2019
- Primary completion1 Jan 2021
- Study completion28 Feb 2021
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 Tracheal Intubation MorbidityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 501 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petr Štourač, MD, Brno University Hospital
- Investigators
- Petr Štourač, assoc.Prof.MD.Ph.D, Study chair, KDAR FN Brno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03747250
- Sponsor's protocol ID
- KDAR FN Brno 2018/12
- Acronym
- Videoscopy
- Status last verified
- Feb 2020
- First submitted
- 16 Nov 2018
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Klabusayova E, Klucka J, Kosinova M, Toukalkova M, Stoudek R, Kratochvil M, Marecek L, Svoboda M, Jabandziev P, Urik M, Stourac P. Videolaryngoscopy vs. Direct Laryngoscopy for Elective Airway Management in Paediatric Anaesthesia: A prospective randomised controlled trial. Eur J Anaesthesiol. 2021 Nov 1;38(11):1187-1193. doi: 10.1097/EJA.0000000000001595.
PubMed 34560686
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Videolaryngoscopy Versus Direct Laryngoscopy for Elective Airway Management in Pediatric Anesthesia: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03747250
- Acronym / sponsor ID
- Videoscopy / KDAR FN Brno 2018/12
- Conditions
- Tracheal Intubation Morbidity
- Keywords
- Videolaryngoscopy, Laryngoscopy, Tracheal intubation, Success rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 501 participants (actual)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 20 Nov 2018 (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.
Videolaryngoscopy can lead to superior airway conditions and to the possible higher success compared to standard direct laryngoscopy. Patient will be randomized to the interventional group (videolaryngoscopy) and control group (direct laryngoscopy). The first attempt success rate, time to first end-tidal CO2 (ETCO2) wave, overall success rate, incidence of aspiration, bradycardia, desaturation a overall complications will be monitored.
Detailed description
Videolaryngoscopy is specialized equipment for airway management, where a camera located at the tip of the laryngoscope blade can visualize also structures that can´t be seen on direct laryngoscopy, co the operator can obtain superior view of aditus laryngis during intubation. Currently videolaryngoscopy is not routinely used for intubation and it is reserved for patients with difficult airway. The aim of the trial is to compare the elective use of videolaryngoscopy versus direct laryngoscopy for elective airway management (tracheal intubation). Patients after informed consent approval will be randomized to the interventional group (videolaryngoscopy) and control group (laryngoscopy). The randomization will be managed by the Institute of Biostatistics and Analyses by the Faculty of medicine, Masaryk university. The primary aim will be the first intubation attempt success rate, the secondary aims will be time to successful intubation (time to first ETCO2 wave), overall success rate, number of intubation attempts, incidence of aspiration, desaturation and incidence of overall complications in all operators, in trainees, residents (5-10 years of practice), consultants (10-15 years of clinical practice) and consultants with over 15 years of clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Videolaryngoscopy | Experimental | Device: VideolaryngoscopyPediatric patients undergoing elective surgery with planned tracheal intubation for airway management. The tracheal intubation will be performed with the use of videolaryngoscope |
| Direct laryngoscopy | Active comparator | Device: Direct laryngoscopyPediatric patients undergoing elective surgery with planned tracheal intubation for airway management. The tracheal intubation will be performed with the use of direct laryngoscopy |
Who may qualify
- Ages
- 29 days to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Pediatric patients scheduled for elective surgery
- Planned tracheal intubation for airway management during surgery
- Signed informed consent
Key exclusion criteria (4 listed)
- Emergency surgery
- Other airway management plan
- age outside the predefined limits
- Informed consent not signed
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 |
|---|---|---|
| VideolaryngoscopyIn experimental group (interventional group), patients will be intubated with the videolaryngoscope | Device | Videolaryngoscopy |
| Direct laryngoscopyIn control group (active comparator group), patients will be intubated with the direct laryngoscope | Device | Direct laryngoscopy |
Primary outcome
First intubation attempt success rate
Time frame: Intraoperatively
Success rate of the first intubation attempt
4 secondary outcomes
Time for successful intubation
Time frame: Intraoperatively
Overall intubation success rate
Time frame: Intraoperatively
Laryngeal view
Time frame: Intraoperatively
Complications
Time frame: Intraoperatively
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 23 Mar 2021.
- Derived from this study: PubMed 34560686Klabusayova E, Klucka J, Kosinova M, Toukalkova M, Stoudek R, Kratochvil M, Marecek L, Svoboda M, Jabandziev P, Urik M, Stourac P. Videolaryngoscopy vs. Direct Laryngoscopy for Elective Airway Management in Paediatric Anaesthesia: A prospective randomised controlled trial. Eur J Anaesthesiol. 2021 Nov 1;38(11):1187-1193. doi: 10.1097/EJA.0000000000001595.
- Individual participant dataSharing planned: Undecided
Related trials for Tracheal Intubation Morbidity
Recruiting
Optimisation Strategy for Emergency Tracheal Intubation
Emergencies, Out-of-hospital Setting
Not yet recruitingPhase 2/3
Oral Melatonin VS Nebulized Dexmedetomidine Premedication on Attenuation of Hemodynamic Response to Direct Laryngoscopy and Tracheal Intubation in Hypertensive Patients
Tracheal Intubation Morbidity, Laryngoscopy
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.
Petr Štourač, assoc.Prof.MD.Ph.D study chair
KDAR FN Brno
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Videolaryngoscopy and Direct laryngoscopy in people with Tracheal Intubation Morbidity, run by Brno University Hospital at 1 site in Czechia.
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 4 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 23 Mar 2021. 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 Czechia. 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?
First intubation attempt success rate (time frame: Intraoperatively). 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 NCT03747250, 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 23 Mar 2021.