The Time Taken for Successful Tracheal Intubation in Each TechniqueNCT06655168
Orotracheal Intubation in Newborns: Videolaryngoscopy Vs Direct Laryngoscopy
A study testing Video Laryngoscopy and Direct Laryngoscopy in people with The Time Taken for Successful Tracheal Intubation in Each Technique, run by Tunis University at 1 site in Tunisia.
Trial summary
The children were randomized into two groups to receive orotracheal intubation after anesthetic induction with neuromuscular blockade, either by direct laryngoscopy (DL, DL group) or by C-MAC video laryngoscopy (VL group) Read more about this study
- Who is it for?
- Ages 1 minute to 30 days
- Conditions the study is for
- The Time Taken for Successful Tracheal Intubation in Each Technique
- What is being tested?
- Video Laryngoscopy and Direct Laryngoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteTunisia
- Study dates
- 17 Dec 2023to 31 Mar 2025
- 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 minute to 30 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- newborns requiring orotracheal intubation for surgery or mechanical ventilation in the intensive care unit
Who cannot join
- age> 01 month
Trial locations and contacts
1 site in 1 country.
Tunisia1 site, 1 recruiting
- Recruiting
Bechir Hamza hospital
Tunis, Tunis Governorate, 2001
salma Aouadi, 0021656652210, salmaaouadi1@gmail.com
About this study
The children were randomized into two groups to receive orotracheal intubation after anesthetic induction with neuromuscular blockade, either by direct laryngoscopy (DL, DL group) or by C-MAC video laryngoscopy (VL group)
Read the detailed description
prospective randomized study including newborns , requiring orotracheal intubation for surgery or mechanical ventilation in the intensive care unit. The children were randomized into two groups to receive orotracheal intubation after anesthetic induction with neuromuscular blockade, either by direct laryngoscopy (DL, DL group) or by C-MAC video laryngoscopy (VL group).
- Being tested
- Video Laryngoscopy, Direct Laryngoscopy
- Keywords
- endotracheal intubation, newborn, direct laryngoscopy,video laryngoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video LaryngoscopyDevice
orotracheal intubation by C-Mac ( Video laryngoscopy)
Direct LaryngoscopyDevice
Orotracheal intubation using Direct Laryngoscopy
| Study group | Role | What they receive |
|---|---|---|
| Video laryngoscopy | Other | Not described Receives: Device: Video Laryngoscopy |
| Direct laryngoscopy | Other | Not described Receives: Device: Direct Laryngoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
time taken for successful tracheal intubation
Measured: during intubation
Secondary outcomes (3)
the need for additional device
Measured: during intubation
the number of attempts
Measured: during intubation
Complications during intubation
complications such as desaturation and selective intubation.
Measured: during intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start17 Dec 2023
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Time Taken for Successful Tracheal Intubation in Each TechniqueStudies 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
- None (open label)
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tunis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehdi Trifa, Tunis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655168
- Sponsor's protocol ID
- 212023
- Status last verified
- Oct 2024
- First submitted
- 22 Oct 2024
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orotracheal Intubation in Newborns: Videolaryngoscopy Vs Direct Laryngoscopy
- ClinicalTrials.gov ID
- NCT06655168
- Acronym / sponsor ID
- 212023
- Keywords
- endotracheal intubation, newborn, direct laryngoscopy,video laryngoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Tunis UniversityUniversity, hospital or other
- Study start
- 17 Dec 2023 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 23 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.
The children were randomized into two groups to receive orotracheal intubation after anesthetic induction with neuromuscular blockade, either by direct laryngoscopy (DL, DL group) or by C-MAC video laryngoscopy (VL group)
Detailed description
prospective randomized study including newborns , requiring orotracheal intubation for surgery or mechanical ventilation in the intensive care unit. The children were randomized into two groups to receive orotracheal intubation after anesthetic induction with neuromuscular blockade, either by direct laryngoscopy (DL, DL group) or by C-MAC video laryngoscopy (VL group).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video laryngoscopy | Other | Device: Video Laryngoscopy |
| Direct laryngoscopy | Other | Device: Direct Laryngoscopy |
Who may qualify
- Ages
- 1 minute to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- newborns requiring orotracheal intubation for surgery or mechanical ventilation in the intensive care unit
Key exclusion criteria (1 listed)
- age> 01 month
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 |
|---|---|---|
| Video Laryngoscopyorotracheal intubation by C-Mac ( Video laryngoscopy) | Device | Video laryngoscopy |
| Direct LaryngoscopyOrotracheal intubation using Direct Laryngoscopy | Device | Direct laryngoscopy |
Primary outcome
time taken for successful tracheal intubation
Time frame: during intubation
3 secondary outcomes
the need for additional device
Time frame: during intubation
the number of attempts
Time frame: during intubation
Complications during intubation
Time frame: during intubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
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?
A study testing Video Laryngoscopy and Direct Laryngoscopy in people with The Time Taken for Successful Tracheal Intubation in Each Technique, run by Tunis University at 1 site in Tunisia.
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 23 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 Tunisia. 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 salma Aouadi, Hospital university assistant (0021656652210, salmaaouadi1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time taken for successful tracheal intubation (time frame: during intubation). 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 23 Oct 2024.