Intubating ConditionNCT06521749
Universal Stylet Bougie in Patients with Cervical Neck Immobilization.
A study testing USB as a stylet and USB as a bougie in people with Intubating Condition, run by Theodor Bilharz Research Institute at 1 site in Egypt.
Trial summary
In patients with cervical spine injury, securing the airway while adequately immobilizing the cervical spine to avoid secondary neurological damage is very challenging. Although awake fiber-optic intubation is the most reliable method in patients with cervical trauma, it has some limitations such as lack of… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Intubating Condition
- What is being tested?
- USB as a stylet and USB as a bougie
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Mar 2024to 15 Jul 2024
- 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 (American society of Anesthesiologists) physical status 1-2.
- Age 18- 60 years old of both sexes.
- Patients undergoing elective surgery under general anesthesia and tracheal intubation.
Who cannot join
- Age < 18 years and ≥ 60 years
- Pregnancy
- Patients with BMI >35 kg m-2
- Emergency surgery or full stomach
- Patients with suspected difficult airway {e.g., high neck circumference, airway masses, mouth scars, neck scars, or history of snoring).
- Patients with cervical spine pathology
- Patients with any cardiac disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Use of the Universal Stylet Bougie (USB) on Successful Intubation on the First Attempt Among Patients with Cervical Spine Immobilization by Using a Rigid Collar.
In patients with cervical spine injury, securing the airway while adequately immobilizing the cervical spine to avoid secondary neurological damage is very challenging. Although awake fiber-optic intubation is the most reliable method in patients with cervical trauma, it has some limitations such as lack of availability, need for expertise in the use, difficulty with non-cooperative patients, or presence of blood or secretions in the airway. Two devices are commonly used to facilitate tracheal intubation: a stylet or a tracheal tube introducer ("bougie").
Read the detailed description
The Universal Stylet Bougie, or USB™, represents a significant advance in the design and development of tracheal introducers (bougies) and stylets. Traditionally, the design requirements of styles and bougies have always been considered incompatible. A stylet requires sufficient rigidity to allow the tracheal tube to be manipulated to a variety of angles, whereas a bougie needs to be flexible enough to allow positive tracheal ring feedback to allow correct placement.
The unique design of the USB™ means the device can be used as a stylet or as a bougie. It consists of two metals inserted on both sides and a flexible middle section. The USB can easily be manipulated to a variety of angles when used as a stylet, yet has the flexibility when used as a bougie. In addition, the hexagonal shape provides less contact with the inner surface of the tracheal tube, providing particularly easy insertion and removal.
In this study we are simulating a difficult intubating condition by limiting the cervical neck extension through applying a rigid neck collar. Subsequently, we will assess whether using the USB device could improve the successful rate of intubation in these patients.
- Conditions
- Intubating Condition
- Being tested
- USB as a stylet, USB as a bougie
- Keywords
- USB, cervical immobilization, rigid collar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
USB as a styletDevice
USB used as a bougie
USB as a bougieDevice
USB used as a bougie
| Study group | Role | What they receive |
|---|---|---|
| the Bougie group (group A) | Active comparator | Endotracheal intubation will be attempted using the video laryngoscope and the USB device will be used as a bougie. Receives: Device: USB as a bougie |
| the stylet group ( B group) | Active comparator | Endotracheal intubation will be attempted using the video laryngoscope and using the USB device as a stylet. Receives: Device: USB as a stylet |
| the control group (C group) | No intervention | Intubation of the trachea with an endotracheal tube will be attempted by using only the video laryngoscopy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time required for intubation.
Measured: 30 seconds - 2 minutes
Secondary outcomes (1)
number of attempts
Measured: 30 seconds to 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start3 Mar 2024
- Primary completion30 Jun 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intubating ConditionStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be allocated, according to the study group into: 1. Bougie Group: (Group A) Endotracheal intubation will be attempted using the video laryngoscope and the USB device will be used as a bougie. 2. Stylet Group: ( Group B) Endotracheal intubation will be attempted using the video laryngoscope and using the USB device as a stylet. 3. Control Group: (Group C) Intubation of the trachea with an endotracheal tube will be attempted by using only the video laryngoscopy.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theodor Bilharz Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moshira sayed mohamed, Theodor Bilharz Research Institute
- Investigators
- Moshira Amer, M.D., Principal investigator, Theodor Bilharz Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06521749
- Sponsor's protocol ID
- PT(823)
- Status last verified
- Jul 2024
- First submitted
- 21 Jul 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data will be available upon request from the principal investigator.
Publications
Maremanda KR, Jayaram K, Durga P. Comparison of Intubation Conditions Between Airtraq, McGrath Video Laryngoscopes, and Macintosh Under Conditions of Simulated Trauma Airway and Rapid Sequence Induction Intubation. J Emerg Med. 2023 Mar;64(3):271-281. doi: 10.1016/j.jemermed.2022.12.014. Epub 2023 Mar 2.
PubMed 36868945Karlsen KAH, Gisvold SE, Nordseth T, Fasting S. Incidence, causes, and management of failed awake fibreoptic intubation-A retrospective study of 833 procedures. Acta Anaesthesiol Scand. 2023 Nov;67(10):1341-1347. doi: 10.1111/aas.14313. Epub 2023 Aug 16.
PubMed 37587618Kuo YM, Lai HY, Tan EC, Li YS, Chiang TY, Huang SS, Huang WC, Chu YC. Cervical spine immobilization does not interfere with nasotracheal intubation performed using GlideScope videolaryngoscopy: a randomized equivalence trial. Sci Rep. 2022 Mar 8;12(1):4041. doi: 10.1038/s41598-022-08035-0.
PubMed 35260735
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Use of the Universal Stylet Bougie (USB) on Successful Intubation on the First Attempt Among Patients with Cervical Spine Immobilization by Using a Rigid Collar.
- ClinicalTrials.gov ID
- NCT06521749
- Acronym / sponsor ID
- PT(823)
- Conditions
- Intubating Condition
- Keywords
- USB, cervical immobilization, rigid collar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Theodor Bilharz Research InstituteUniversity, hospital or other
- Study start
- 3 Mar 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 26 Jul 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 patients with cervical spine injury, securing the airway while adequately immobilizing the cervical spine to avoid secondary neurological damage is very challenging. Although awake fiber-optic intubation is the most reliable method in patients with cervical trauma, it has some limitations such as lack of availability, need for expertise in the use, difficulty with non-cooperative patients, or presence of blood or secretions in the airway. Two devices are commonly used to facilitate tracheal intubation: a stylet or a tracheal tube introducer ("bougie").
Detailed description
The Universal Stylet Bougie, or USB™, represents a significant advance in the design and development of tracheal introducers (bougies) and stylets. Traditionally, the design requirements of styles and bougies have always been considered incompatible. A stylet requires sufficient rigidity to allow the tracheal tube to be manipulated to a variety of angles, whereas a bougie needs to be flexible enough to allow positive tracheal ring feedback to allow correct placement.
The unique design of the USB™ means the device can be used as a stylet or as a bougie. It consists of two metals inserted on both sides and a flexible middle section. The USB can easily be manipulated to a variety of angles when used as a stylet, yet has the flexibility when used as a bougie. In addition, the hexagonal shape provides less contact with the inner surface of the tracheal tube, providing particularly easy insertion and removal.
In this study we are simulating a difficult intubating condition by limiting the cervical neck extension through applying a rigid neck collar. Subsequently, we will assess whether using the USB device could improve the successful rate of intubation in these patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Patients will be allocated, according to the study group into: 1. Bougie Group: (Group A) Endotracheal intubation will be attempted using the video laryngoscope and the USB device will be used as a bougie. 2. Stylet Group: ( Group B) Endotracheal intubation will be attempted using the video laryngoscope and using the USB device as a stylet. 3. Control Group: (Group C) Intubation of the trachea with an endotracheal tube will be attempted by using only the video laryngoscopy.
| Arm | Type | Receives |
|---|---|---|
| the Bougie group (group A) | Active comparator | Device: USB as a bougieEndotracheal intubation will be attempted using the video laryngoscope and the USB device will be used as a bougie. |
| the stylet group ( B group) | Active comparator | Device: USB as a styletEndotracheal intubation will be attempted using the video laryngoscope and using the USB device as a stylet. |
| the control group (C group) | No intervention | –Intubation of the trachea with an endotracheal tube will be attempted by using only the video laryngoscopy. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA (American society of Anesthesiologists) physical status 1-2.
- Age 18- 60 years old of both sexes.
- Patients undergoing elective surgery under general anesthesia and tracheal intubation.
Key exclusion criteria (7 listed)
- Age < 18 years and ≥ 60 years
- Pregnancy
- Patients with BMI >35 kg m-2
- Emergency surgery or full stomach
- Patients with suspected difficult airway {e.g., high neck circumference, airway masses, mouth scars, neck scars, or history of snoring).
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 |
|---|---|---|
| USB as a styletUSB used as a bougie | Device | the stylet group ( B group) |
| USB as a bougieUSB used as a bougie | Device | the Bougie group (group A) |
Primary outcome
Time required for intubation.
Time frame: 30 seconds - 2 minutes
1 secondary outcome
number of attempts
Time frame: 30 seconds to 2 minutes
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 19 Sep 2024.
- Background: PubMed 36868945Maremanda KR, Jayaram K, Durga P. Comparison of Intubation Conditions Between Airtraq, McGrath Video Laryngoscopes, and Macintosh Under Conditions of Simulated Trauma Airway and Rapid Sequence Induction Intubation. J Emerg Med. 2023 Mar;64(3):271-281. doi: 10.1016/j.jemermed.2022.12.014. Epub 2023 Mar 2.
- Background: PubMed 37587618Karlsen KAH, Gisvold SE, Nordseth T, Fasting S. Incidence, causes, and management of failed awake fibreoptic intubation-A retrospective study of 833 procedures. Acta Anaesthesiol Scand. 2023 Nov;67(10):1341-1347. doi: 10.1111/aas.14313. Epub 2023 Aug 16.
- Background: PubMed 35260735Kuo YM, Lai HY, Tan EC, Li YS, Chiang TY, Huang SS, Huang WC, Chu YC. Cervical spine immobilization does not interfere with nasotracheal intubation performed using GlideScope videolaryngoscopy: a randomized equivalence trial. Sci Rep. 2022 Mar 8;12(1):4041. doi: 10.1038/s41598-022-08035-0.
- Individual participant dataSharing planned: No. data will be available upon request from the principal investigator.
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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.
Moshira Amer, M.D. principal investigator
Theodor Bilharz Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing USB as a stylet and USB as a bougie in people with Intubating Condition, run by Theodor Bilharz Research Institute 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 7 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 19 Sep 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 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?
Time required for intubation. (time frame: 30 seconds - 2 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06521749, which also lists 3 linked publications.
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 19 Sep 2024.