Airway ObstructionNCT04730362
Effect of Laryngeal Mask Airway on Image Quality n Pediatric Patients Undergoing Magnetic Resonant Imaging
A study testing guedel airway, supraglottic airway and propofol bolus and then anesthesia sevoflurane in people with Airway Obstruction, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
This study compare the effects of Oral airway vs LMA in preventing anesthesia-induced partial airway obstruction, in an attempt to lessen MRI motion artifacts, which would result in improvements in image quality. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Airway Obstruction
- What is being tested?
- guedel airway, supraglottic airway and propofol bolus and then anesthesia sevoflurane
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2021to 1 Mar 2022
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- ASA І and II patients
- Age under 18 years .
- The patient will need GA and patient Scheduled for MRI brain.
Who cannot join
- Glasgow coma scale ≤ 8
- Emergency patient with full stomach.
- Distorted upper airway anatomy making intubation with GA mandatory.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Laryngeal Mask Airway on Image Quality n Pediatric Patients Undergoing Magnetic Resonant Imaging: a Randomized Controlled Trial
This study compare the effects of Oral airway vs LMA in preventing anesthesia-induced partial airway obstruction, in an attempt to lessen MRI motion artifacts, which would result in improvements in image quality.
Read the detailed description
Magnetic resonance image (MRI) is a frequently used imaging technique especially in oncological patients, where it is used for diagnosis, following up response to treatment and later for detection of possible recurrence. The main problem encountered with MRI is the long time required for completion of the imaging, during which the patient is required to lie still. Patients who are unable to lie still require sedation or general anesthesia (GA). Almost all pediatric patients are uncooperative, making GA, the standard of care for pediatric MRI.
Several general anesthetic techniques including airway management by endotracheal tube \& various supraglottic devices (LMA) have been described. Choice of technique by anesthesiologist is influenced by the patient's age, craniofacial and airway anatomy, procedure duration, \& illness acuity.
- Conditions
- Airway Obstruction
- Being tested
- guedel airway, supraglottic airway, propofol bolus and then anesthesia sevoflurane
- Medical subject headings
- Airway Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
guedel airwayDevice
Anesthesia will be conducted by induction with 1-2
- Mg/kg of an IV propofol bolus and then anesthesia is maintained with an inhalational anesthesia with sevoflurane 2%-4%. The goal is to maintain the patient spontaneous ventilation throughout the procedure. Monitoring of the patients is done by MRI compatible pulse oximetry for heart rate and oxygen saturation which is connected to MRI control room.
supraglottic airwayDevice
supraglottic airway
propofol bolus and then anesthesia sevofluraneDrug
Mg/kg of an IV propofol bolus and then anesthesia is maintained with an inhalational anesthesia with sevoflurane 2%-4%
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | 20 patients in which a Guedel oral airway will be inserted for airway management and to conduct inhalational anesthetic through face mask fixed with harness to the head and then connected to anesthesia breathing circuit of MRI compatible anesthesia machine for maintenance of anesthesia of O2 and sevoflurane 2-4% . Receives: Device: guedel airway; Drug: propofol bolus and then anesthesia sevoflurane |
| supraglottic group | Active comparator | 20 patients in which supraglottic airway laryngeal mask airway (LMA) will be used and then connected to anesthesia breathing circuit of MRI compatible anesthesia machine for maintenance of anesthesia of O2 and sevoflurane 2-4% . Receives: Device: supraglottic airway; Drug: propofol bolus and then anesthesia sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image quality of each MRI sequence
Image quality of each MRI sequence is evaluated by using a scoring system with the following scores: score of 1 (non-diagnostic), score of 2 (poor quality but some diagnostic value), score of 3 (average), score of 4 (good), and score of 5 (excellent).
Measured: During general anesthesia of MRI investigation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start1 Feb 2021
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ObstructionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Control group : a Guedel oral airway will be inserted for airway management versus supraglottic group patients in which supraglottic airway laryngeal mask airway (LMA) will be used
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Abdelfattah Abdelwadod, National Cancer Institute, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04730362
- Sponsor's protocol ID
- AP2007-50111
- Status last verified
- Apr 2022
- First submitted
- 26 Jan 2021
- Last updated
- 3 May 2022
- 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 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Laryngeal Mask Airway on Image Quality n Pediatric Patients Undergoing Magnetic Resonant Imaging: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04730362
- Acronym / sponsor ID
- AP2007-50111
- Conditions
- Airway Obstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 29 Jan 2021 (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.
This study compare the effects of Oral airway vs LMA in preventing anesthesia-induced partial airway obstruction, in an attempt to lessen MRI motion artifacts, which would result in improvements in image quality.
Detailed description
Magnetic resonance image (MRI) is a frequently used imaging technique especially in oncological patients, where it is used for diagnosis, following up response to treatment and later for detection of possible recurrence. The main problem encountered with MRI is the long time required for completion of the imaging, during which the patient is required to lie still. Patients who are unable to lie still require sedation or general anesthesia (GA). Almost all pediatric patients are uncooperative, making GA, the standard of care for pediatric MRI.
Several general anesthetic techniques including airway management by endotracheal tube \& various supraglottic devices (LMA) have been described. Choice of technique by anesthesiologist is influenced by the patient's age, craniofacial and airway anatomy, procedure duration, \& illness acuity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Control group : a Guedel oral airway will be inserted for airway management versus supraglottic group patients in which supraglottic airway laryngeal mask airway (LMA) will be used
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Device: guedel airway, Drug: propofol bolus and then anesthesia sevoflurane20 patients in which a Guedel oral airway will be inserted for airway management and to conduct inhalational anesthetic through face mask fixed with harness to the head and then connected to anesthesia breathing circuit of MRI compatible anesthesia machine for maintenance of anesthesia of O2 and sevoflurane 2-4% . |
| supraglottic group | Active comparator | Device: supraglottic airway, Drug: propofol bolus and then anesthesia sevoflurane20 patients in which supraglottic airway laryngeal mask airway (LMA) will be used and then connected to anesthesia breathing circuit of MRI compatible anesthesia machine for maintenance of anesthesia of O2 and sevoflurane 2-4% . |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- ASA І and II patients
- Age under 18 years .
- The patient will need GA and patient Scheduled for MRI brain.
Key exclusion criteria (3 listed)
- Glasgow coma scale ≤ 8
- Emergency patient with full stomach.
- Distorted upper airway anatomy making intubation with GA mandatory.
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 |
|---|---|---|
| guedel airwayAnesthesia will be conducted by induction with 1-2 • Mg/kg of an IV propofol bolus and then anesthesia is maintained with an inhalational anesthesia with sevoflurane 2%-4%. The goal is to maintain the patient spontaneous ventilation throughout the procedure. Monitoring of the patients is done by MRI compatible pulse oximetry for heart rate and oxygen saturation which is connected to MRI control room. | Device | Control group |
| supraglottic airwaysupraglottic airway | Device | supraglottic group |
| propofol bolus and then anesthesia sevofluraneMg/kg of an IV propofol bolus and then anesthesia is maintained with an inhalational anesthesia with sevoflurane 2%-4% | Drug | Control group, supraglottic group |
Primary outcome
Image quality of each MRI sequence
Time frame: During general anesthesia of MRI investigation procedure
Image quality of each MRI sequence is evaluated by using a scoring system with the following scores: score of 1 (non-diagnostic), score of 2 (poor quality but some diagnostic value), score of 3 (average), score of 4 (good), and score of 5 (excellent).
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 3 May 2022.
- 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?
A study testing guedel airway, supraglottic airway and propofol bolus and then anesthesia sevoflurane in people with Airway Obstruction, run by National Cancer Institute, Egypt 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 3 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 3 May 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?
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?
Image quality of each MRI sequence (time frame: During general anesthesia of MRI investigation procedure). 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 3 May 2022.