Pediatric Patients Undergoing OperationNCT06644586
Comparison of Video Laryngoscopy and Macintosh Laryngoscopy in Pediatric Patients Undergoing Elective Surgery
An observational study of Pediatric Patients Undergoing Operation, run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial summary
In this study, we aimed to observe the intubation conditions in patients using Endolarenx video laryngoscope and Macintosh Blade in laryngoscopy to identify the advantages and disadvantages of using video laryngoscopy in pediatric patients. Read more about this study
- Who is it for?
- Ages 1 year to 13 years
- Conditions the study is for
- Pediatric Patients Undergoing Operation
- What is being tested?
- videolaryngoscopy and Direct Laryngoscopy
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 1 Aug 2022
- 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 1 year to 13 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients who underwent elective surgery at Gaziantep University.
Who may be able to join
- One hundred pediatric patients, aged under 18 years, weighing between 10-40 kg, and classified as American Society of Anesthesiologists (ASA) I-II-III risk group
Who cannot join
- Patients with congenital airway deformities, patients with known or predicted difficult intubation, patients undergoing emergency surgery, patients classified above ASA III, and patients whose parents did not consent were excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COMPARISON of VIDEO LARYNGOSCOPY and MACINTOSH LARYNGOSCOPY in PEDIATRIC PATIENTS UNDERGOING ELECTIVE SURGERY
In this study, we aimed to observe the intubation conditions in patients using Endolarenx video laryngoscope and Macintosh Blade in laryngoscopy to identify the advantages and disadvantages of using video laryngoscopy in pediatric patients.
- Conditions
- Pediatric Patients Undergoing Operation
- Being tested
- videolaryngoscopy, Direct Laryngoscopy
- Keywords
- video laryngoscopy, direct laryngoscopy, pediatric patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
videolaryngoscopyOther
The patients intubated with video laryngoscopy
Direct LaryngoscopyOther
The patients intubated with direct laryngoscopy
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean intubation time
Measured: The time from the entry of the laryngoscope into the oral cavity until the appearance of the EtCO2 trace on the capnograph.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start1 Apr 2022
- Primary completion1 Jun 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Patients Undergoing OperationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elzem SEN, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06644586
- Sponsor's protocol ID
- 2022/100
- Status last verified
- Oct 2024
- First submitted
- 14 Oct 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON of VIDEO LARYNGOSCOPY and MACINTOSH LARYNGOSCOPY in PEDIATRIC PATIENTS UNDERGOING ELECTIVE SURGERY
- ClinicalTrials.gov ID
- NCT06644586
- Acronym / sponsor ID
- 2022/100
- Conditions
- Pediatric Patients Undergoing Operation
- Keywords
- video laryngoscopy, direct laryngoscopy, pediatric patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 16 Oct 2024 (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 this study, we aimed to observe the intubation conditions in patients using Endolarenx video laryngoscope and Macintosh Blade in laryngoscopy to identify the advantages and disadvantages of using video laryngoscopy in pediatric patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients who underwent elective surgery at Gaziantep University.
Key inclusion criteria (1 listed)
- One hundred pediatric patients, aged under 18 years, weighing between 10-40 kg, and classified as American Society of Anesthesiologists (ASA) I-II-III risk group
Key exclusion criteria (1 listed)
- Patients with congenital airway deformities, patients with known or predicted difficult intubation, patients undergoing emergency surgery, patients classified above ASA III, and patients whose parents did not consent were excluded from 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 |
|---|---|---|
| videolaryngoscopyThe patients intubated with video laryngoscopy | Other | – |
| Direct LaryngoscopyThe patients intubated with direct laryngoscopy | Other | – |
Primary outcome
Mean intubation time
Time frame: The time from the entry of the laryngoscope into the oral cavity until the appearance of the EtCO2 trace on the capnograph.
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 16 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pediatric Patients Undergoing Operation, run by University of Gaziantep 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: finished, as of the sponsor's last update on 16 Oct 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?
Mean intubation time (time frame: The time from the entry of the laryngoscope into the oral cavity until the appearance of the EtCO2 trace on the capnograph.). 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 16 Oct 2024.