Difficult IntubationNCT05744388
Modification of the Stylet Shape of the Glidescope for Facilitating Difficult Intubation
A study testing Gliderite® shape modification in people with Difficult Intubation, run by Ain Shams University.
Trial summary
The undersurface of the disposable blade of the Glidescope will be lubricated by a jelly substance to facilitate its entrance to the mouth without trauma to the soft tissues. In addition the stylet ( Gliderite) shape will be modified to be an obtuse angle. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Difficult Intubation
- What is being tested?
- Gliderite® shape modification
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2023to 1 Jul 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA physical status II or III
- BMI more than 35
- Patients presenting with at least one predictor for a difficult airway.
- The airway difficulty is at least score 3 as an indicator of difficulty.
Who cannot join
- Patients who may need rapid sequence induction
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy of Lubricating the Under Surface of Glidescope Blade Stylet Shape Modification to Facilitate Endotracheal Intubation for Suspected Difficult Intubation; A Prospective Randomized Controlled Trial
The undersurface of the disposable blade of the Glidescope will be lubricated by a jelly substance to facilitate its entrance to the mouth without trauma to the soft tissues. In addition the stylet ( Gliderite) shape will be modified to be an obtuse angle. This technique modification will be applied for obese patients with suspected difficult intubation criteria who are scheduled for bariatric surgeries.
Read the detailed description
Endotracheal tube diameter size 7.5 mm and disposable rigid blade size 3 for the female patients and ETT diameter size 8.00 mm and disposable rigid blade size 4 for the male patients will be prepared. The under surface of the blade will be lubricated by soluble jelly, taking care not to touch the camera source of light.
The stylet will be more obtuse angle than the standard shape. The stylet will be lubricated also before being fitted inside the endotracheal tube. The blade will be introduced inside the mouth midline, the tube will be held from the upper third and introduced in the midline also sliding over the blade and introduced inside the glottis. Once the tip of the tube introduced inside the glottis, the stylet will be removed and the tube will be advanced more inside the trachea. The equality of air entry will be assessed by the stethoscope and the tube will by fixed by adhesive tape after inflating the cuff.
If during intubation the used technique failed to introduce the tube, we will do ETT rotation inside the mouth or upward stylet angulation outside the mouth then will be reintroduced again. If Glidescope failed to intubate, we will use intubating LMA to intubate the patients. If all trials failed to intubate the patients. Sugamadex 16 mg/Kg will be injected to awaken the patients. After intubation the large gastric tube will be introduced in the esophagus under vision by the Glidescope help also.
Group 2:
The second group will be a control group, they will be handled by the standard shape of the stylet and the blade without lubrication.
- Conditions
- Difficult Intubation
- Being tested
- Gliderite® shape modification
- Keywords
- difficult intubation, blade lubrication, stylet shape
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gliderite® shape modificationDevice
Also called Lubrication of the disposable blade by a jelly substance
The stylet will be more obtuse angle than the standard shape. The stylet will be lubricated also before being fitted inside the endotracheal tube. The blade will be introduced inside the mouth midline, the tube will be held from the upper third and introduced in the midline also sliding over the blade and introduced inside the glottis.
| Study group | Role | What they receive |
|---|---|---|
| Stylet shape modification group | Active comparator | Endotracheal tube diameter size 7.5 mm and disposable rigid blade size 3 for the female patients and ETT diameter size 8.00 mm and disposable rigid blade size 4 for the male patients will be prepared. The under surface of the blade will be lubricated by soluble jelly, taking care not to touch the camera source of light.
The stylet will be more obtuse angle than the standard shape. The stylet will be lubricated also before being fitted inside the endotracheal tube. The blade will be introduced inside the mouth midline, the tube will be held from the upper third and introduced in the midline also sliding over the blade and introduced inside the glottis. Once the tip of the tube introduced inside the glottis, the stylet will be removed and the tube will be advanced more inside the trachea. The equality of air entry will be assessed by the stethoscope and the tube will by fixed by adhesive tape after inflating the cuff. Receives: Device: Gliderite® shape modification |
| Standard shape of the stylet group | No intervention | The second group will be a control group, they will be handled by the standard shape of the stylet and the blade without lubrication. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation time in seconds
the intubation time will be calculated in seconds from the video screen of the Glidescope watch
Measured: intraoperative time
Secondary outcomes (2)
Number of trials of endotracheal intubation
the intubation time will be recorded
Measured: intraoperative time
mucosal damage during the intubation
The blade under surface will be observed for blood spots. And the oral cavity will be viewed for mucosal damage or obscured view.
Measured: intraoperative time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start1 Mar 2023 (estimated)
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult IntubationStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized prospective study
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabah Nageeb, Ain Shams University
- Investigators
- Sabah Ayoub, MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05744388
- Sponsor's protocol ID
- Glidescope
- Status last verified
- Feb 2023
- First submitted
- 3 Feb 2023
- Last updated
- 27 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Lubricating the Under Surface of Glidescope Blade Stylet Shape Modification to Facilitate Endotracheal Intubation for Suspected Difficult Intubation; A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05744388
- Acronym / sponsor ID
- Glidescope
- Conditions
- Difficult Intubation
- Keywords
- difficult intubation, blade lubrication, stylet shape
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 27 Feb 2023 (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 undersurface of the disposable blade of the Glidescope will be lubricated by a jelly substance to facilitate its entrance to the mouth without trauma to the soft tissues. In addition the stylet ( Gliderite) shape will be modified to be an obtuse angle. This technique modification will be applied for obese patients with suspected difficult intubation criteria who are scheduled for bariatric surgeries.
Detailed description
Endotracheal tube diameter size 7.5 mm and disposable rigid blade size 3 for the female patients and ETT diameter size 8.00 mm and disposable rigid blade size 4 for the male patients will be prepared. The under surface of the blade will be lubricated by soluble jelly, taking care not to touch the camera source of light.
The stylet will be more obtuse angle than the standard shape. The stylet will be lubricated also before being fitted inside the endotracheal tube. The blade will be introduced inside the mouth midline, the tube will be held from the upper third and introduced in the midline also sliding over the blade and introduced inside the glottis. Once the tip of the tube introduced inside the glottis, the stylet will be removed and the tube will be advanced more inside the trachea. The equality of air entry will be assessed by the stethoscope and the tube will by fixed by adhesive tape after inflating the cuff.
If during intubation the used technique failed to introduce the tube, we will do ETT rotation inside the mouth or upward stylet angulation outside the mouth then will be reintroduced again. If Glidescope failed to intubate, we will use intubating LMA to intubate the patients. If all trials failed to intubate the patients. Sugamadex 16 mg/Kg will be injected to awaken the patients. After intubation the large gastric tube will be introduced in the esophagus under vision by the Glidescope help also.
Group 2:
The second group will be a control group, they will be handled by the standard shape of the stylet and the blade without lubrication.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized prospective study
| Arm | Type | Receives |
|---|---|---|
| Stylet shape modification group | Active comparator | Device: Gliderite® shape modificationEndotracheal tube diameter size 7.5 mm and disposable rigid blade size 3 for the female patients and ETT diameter size 8.00 mm and disposable rigid blade size 4 for the male patients will be prepared. The under surface of the blade will be lubricated by soluble jelly, taking care not to touch the camera source of light. The stylet will be more obtuse angle than the standard shape. The stylet will be lubricated also before being fitted inside the endotracheal tube. The blade will be introduced inside the mouth midline, the tube will be held from the upper third and introduced in the midline also sliding over the blade and introduced inside the glottis. Once the tip of the tube introduced inside the glottis, the stylet will be removed and the tube will be advanced more inside the trachea. The equality of air entry will be assessed by the stethoscope and the tube will by fixed by adhesive tape after inflating the cuff. |
| Standard shape of the stylet group | No intervention | –The second group will be a control group, they will be handled by the standard shape of the stylet and the blade without lubrication. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- ASA physical status II or III
- BMI more than 35
- Patients presenting with at least one predictor for a difficult airway.
- The airway difficulty is at least score 3 as an indicator of difficulty.
Key exclusion criteria (1 listed)
- Patients who may need rapid sequence induction
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 |
|---|---|---|
| Gliderite® shape modificationAlso: Lubrication of the disposable blade by a jelly substanceThe stylet will be more obtuse angle than the standard shape. The stylet will be lubricated also before being fitted inside the endotracheal tube. The blade will be introduced inside the mouth midline, the tube will be held from the upper third and introduced in the midline also sliding over the blade and introduced inside the glottis. | Device | Stylet shape modification group |
Primary outcome
Intubation time in seconds
Time frame: intraoperative time
the intubation time will be calculated in seconds from the video screen of the Glidescope watch
2 secondary outcomes
Number of trials of endotracheal intubation
Time frame: intraoperative time
mucosal damage during the intubation
Time frame: intraoperative time
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
- 5\. Ryo Wakabayashi1\*, Yuki Shiko2 , Tomofumi Kodaira1 , Yuko Shiroshita1 , Hitomi Otsuka1 , Kosuke Baba1 \& Norimasa Hishinuma Efcacy of stylet angulation at the holding position during tracheal intubation with a videolaryngoscope: a randomized controlledLink provided by the sponsor.
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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.
Sabah Ayoub, MD principal investigator
Ain Shams University
Questions about this trial
What is this clinical trial studying?
A study testing Gliderite® shape modification in people with Difficult Intubation, run by Ain Shams University.
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 4 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 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Sabah Ayoub, MD (966563887242 ext. 563887242, sabah_nageeb@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intubation time in seconds (time frame: intraoperative time). 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 27 Feb 2023.