Endotracheal Tube Wrongly Placed During Anesthetic ProcedureNCT05513989
Modified Magill Forceps Facilitating Nasal Intubation for Children Undergoing Dental Operations
A study testing modified Magill forceps and Magill forceps in people with Endotracheal Tube Wrongly Placed During Anesthetic Procedure, run by Ain Shams University at 1 site in Egypt.
Trial summary
compare between Magill forceps and modified pediatric Magill forceps for nasotracheal intubation (which method is easier and better?). Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Endotracheal Tube Wrongly Placed During Anesthetic Procedure
- What is being tested?
- modified Magill forceps and Magill forceps
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2022to 1 Jan 2023
- 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 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with the American Society of Anesthesiology physical status of 1 or 2
- Age 4 to 8 years old.
- Elective dental surgeries.
Who cannot join
- Parental refusal to consent (absolute contraindication),
- Patients with aspiration risk.
- Known upper airway abnormalities.
- Those having difficult airway.
Trial locations and contacts
1 site in 1 country.
About this study
compare between Magill forceps and modified pediatric Magill forceps for nasotracheal intubation (which method is easier and better?).
Read the detailed description
Group A One hundred and ten patients for whom modified pediatric Magill forceps was used to assist nasotracheal intubation.
Group B One hundred and ten patients for whom Magill forceps was used to assist nasotracheal intubation.
For each patient, intubation time, number of intubation attempts, hypoxia (recognized when oxygen saturation decreases below 94%), pharyngeal trauma, and need for corkscrewing will be recorded.
- Being tested
- modified Magill forceps, Magill forceps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified Magill forcepsDevice
modified pediatric Magill forceps was used to assist nasotracheal intubation.
Magill forcepsDevice
Magill forceps was used to assist nasotracheal intubation.
| Study group | Role | What they receive |
|---|---|---|
| modified Magill forceps group | Active comparator | One hundred and ten patients for whom modified pediatric Magill forceps was used to assist nasotracheal intubation Receives: Device: modified Magill forceps |
| Magill forceps group | Active comparator | One hundred and ten patients for whom Magill forceps was used to assist nasotracheal intubation. Receives: Device: Magill forceps |
What is being measured
The primary outcome is the main question the study is designed to answer.
intubation time
Measured: just after anesthesia induction for 30 minutes
Secondary outcomes (4)
number of intubation attempts
Measured: after anesthesia induction for 30 minutes
hypoxia
Measured: after anesthesia induction for 30 minutes
pharyngeal trauma
Measured: after intubation for 30 minutes
need for corkscrewing
Measured: after anesthesia induction for 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start1 Sep 2022 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endotracheal Tube Wrongly Placed During Anesthetic ProcedureStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RAMY AHMED, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05513989
- Sponsor's protocol ID
- IRB00006379 MMF
- Status last verified
- Aug 2022
- First submitted
- 16 Aug 2022
- Last updated
- 24 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Magill Forceps Facilitating Nasal Intubation for Children Undergoing Dental Operations
- ClinicalTrials.gov ID
- NCT05513989
- Acronym / sponsor ID
- IRB00006379 MMF
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 24 Aug 2022 (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.
compare between Magill forceps and modified pediatric Magill forceps for nasotracheal intubation (which method is easier and better?).
Detailed description
Group A One hundred and ten patients for whom modified pediatric Magill forceps was used to assist nasotracheal intubation.
Group B One hundred and ten patients for whom Magill forceps was used to assist nasotracheal intubation.
For each patient, intubation time, number of intubation attempts, hypoxia (recognized when oxygen saturation decreases below 94%), pharyngeal trauma, and need for corkscrewing will be recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| modified Magill forceps group | Active comparator | Device: modified Magill forcepsOne hundred and ten patients for whom modified pediatric Magill forceps was used to assist nasotracheal intubation |
| Magill forceps group | Active comparator | Device: Magill forcepsOne hundred and ten patients for whom Magill forceps was used to assist nasotracheal intubation. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients with the American Society of Anesthesiology physical status of 1 or 2
- Age 4 to 8 years old.
- Elective dental surgeries.
Key exclusion criteria (4 listed)
- Parental refusal to consent (absolute contraindication),
- Patients with aspiration risk.
- Known upper airway abnormalities.
- Those having difficult airway.
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 |
|---|---|---|
| modified Magill forcepsmodified pediatric Magill forceps was used to assist nasotracheal intubation. | Device | modified Magill forceps group |
| Magill forcepsMagill forceps was used to assist nasotracheal intubation. | Device | Magill forceps group |
Primary outcome
intubation time
Time frame: just after anesthesia induction for 30 minutes
4 secondary outcomes
number of intubation attempts
Time frame: after anesthesia induction for 30 minutes
hypoxia
Time frame: after anesthesia induction for 30 minutes
pharyngeal trauma
Time frame: after intubation for 30 minutes
need for corkscrewing
Time frame: after anesthesia induction for 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
- Individual participant dataSharing planned: No
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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?
A study testing modified Magill forceps and Magill forceps in people with Endotracheal Tube Wrongly Placed During Anesthetic Procedure, run by Ain Shams University at 1 site in Egypt.
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: status not confirmed, as of the sponsor's last update on 24 Aug 2022. 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 Egypt. 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?
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?
intubation time (time frame: just after anesthesia induction for 30 minutes). 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 Aug 2022.