Intubation; Difficult or FailedNCT05158088
Video Laryngoscope Versus USB Borescope in Difficult Intubation
A study testing Borescope and Video laryngoscope in people with Intubation; Difficult or Failed, run by Cairo University at 1 site in Egypt.
Trial summary
Video Laryngoscope Versus a USB Borescope Aided Endotracheal Intubation in Adults With Anticipated Difficult Airway Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intubation; Difficult or Failed
- What is being tested?
- Borescope and Video laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2021to 1 Apr 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1.American Society of Anesthesiologist ASA physical status I-II patients. 2.Both genders. 3.Age18-60 years old 4.BMI <35 5.patients with El-Ganzouri score more than or equal to 4
Who cannot join
- Presence of pulmonary diseases
- Uncontrolled hypertension
- Ischemic heart disease
- Cervical spine fracture
- Limited mouth opening
- known to have tumors or polyps in the upper airway
- History of difficult intubation or difficult bag-mask ventilation
- Patients with difficult bag-mask ventilation after induction of anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Video Laryngoscope Versus a USB Borescope Aided Endotracheal Intubation in Adults With Anticipated Difficult Airway
Video Laryngoscope Versus a USB Borescope Aided Endotracheal Intubation in Adults With Anticipated Difficult Airway
Read the detailed description
For patients allocated to the USB-borescope technique, a proper size endotracheal tube will be placed over the USB-borescope (with an external diameter of 5.5 mm) which will be coated externally with water-soluble lubricant. The proper size laryngoscope blade will be inserted. The USB-borescope will be placed through the oral cavity and will be advanced while tracking it on a mobile phone, it will be advanced to the glottic opening. If needed, rotation of USB-borescope and/or external laryngeal manipulation will be used to align it with the vocal cord.
For patients allocated to the intubation over Video Laryngoscope technique, video laryngoscope (Insighters insight is3) proper size blade will be placed and introduction of the Video Laryngoscope till viewing the glottis opening then insertion of a proper sized endotracheal tube
- Conditions
- Intubation; Difficult or Failed
- Being tested
- Borescope, Video laryngoscope
- Keywords
- Airway, Intubation, Videolaryngoscope, Borescope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BorescopeDevice
Endotracheal intubation using borescope
Video laryngoscopeDevice
Endotracheal intubation using video laryngoscope
| Study group | Role | What they receive |
|---|---|---|
| Borescope group | Active comparator | Using an Endotracheal tube mounted over Borescope with the aid of conventional laryngoscope for intubation Receives: Device: Borescope |
| Videolaryngoscope group | Active comparator | Using videolaryngoscope for intubation Receives: Device: Video laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of intubation
in seconds
Measured: 5 minutes
Secondary outcomes (5)
Blood pressure before intubation, every 5 minutes after intubation till 15 minutes after intubation
Systolic, diastolic, and mean arterial blood pressures
Measured: 15 minutes
Heart rate Heart rate
Heart rate before intubation, every 5 minutes after intubation till 15 minutes after intubation
Measured: 15 minutes
The degree of view clarity
Cormack-Lehane grading
Measured: 1 minute
Incidence of complications
Incidence of complications as bleeding, failure
Measured: 48 hours
Number of trials for correct endotracheal intubation
Number of trial till successful intubation
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start20 Dec 2021
- Primary completion28 Mar 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation; Difficult or FailedStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohamed abdelghany ali, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05158088
- Sponsor's protocol ID
- N-15-2021/MSc
- Status last verified
- Apr 2022
- First submitted
- 22 Aug 2021
- Last updated
- 15 Apr 2022
- 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 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Laryngoscope Versus a USB Borescope Aided Endotracheal Intubation in Adults With Anticipated Difficult Airway
- ClinicalTrials.gov ID
- NCT05158088
- Acronym / sponsor ID
- N-15-2021/MSc
- Conditions
- Intubation; Difficult or Failed
- Keywords
- Airway, Intubation, Videolaryngoscope, Borescope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 28 Mar 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 15 Dec 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.
Video Laryngoscope Versus a USB Borescope Aided Endotracheal Intubation in Adults With Anticipated Difficult Airway
Detailed description
For patients allocated to the USB-borescope technique, a proper size endotracheal tube will be placed over the USB-borescope (with an external diameter of 5.5 mm) which will be coated externally with water-soluble lubricant. The proper size laryngoscope blade will be inserted. The USB-borescope will be placed through the oral cavity and will be advanced while tracking it on a mobile phone, it will be advanced to the glottic opening. If needed, rotation of USB-borescope and/or external laryngeal manipulation will be used to align it with the vocal cord.
For patients allocated to the intubation over Video Laryngoscope technique, video laryngoscope (Insighters insight is3) proper size blade will be placed and introduction of the Video Laryngoscope till viewing the glottis opening then insertion of a proper sized endotracheal tube
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Borescope group | Active comparator | Device: BorescopeUsing an Endotracheal tube mounted over Borescope with the aid of conventional laryngoscope for intubation |
| Videolaryngoscope group | Active comparator | Device: Video laryngoscopeUsing videolaryngoscope for intubation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.American Society of Anesthesiologist ASA physical status I-II patients. 2.Both genders. 3.Age18-60 years old 4.BMI <35 5.patients with El-Ganzouri score more than or equal to 4
Key exclusion criteria (8 listed)
- Presence of pulmonary diseases
- Uncontrolled hypertension
- Ischemic heart disease
- Cervical spine fracture
- Limited mouth opening
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 |
|---|---|---|
| BorescopeEndotracheal intubation using borescope | Device | Borescope group |
| Video laryngoscopeEndotracheal intubation using video laryngoscope | Device | Videolaryngoscope group |
Primary outcome
Time of intubation
Time frame: 5 minutes
in seconds
5 secondary outcomes
Blood pressure before intubation, every 5 minutes after intubation till 15 minutes after intubation
Time frame: 15 minutes
Heart rate Heart rate
Time frame: 15 minutes
The degree of view clarity
Time frame: 1 minute
Incidence of complications
Time frame: 48 hours
Number of trials for correct endotracheal intubation
Time frame: 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 15 Apr 2022.
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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 Borescope and Video laryngoscope in people with Intubation; Difficult or Failed, run by Cairo 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 1 inclusion and 8 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 15 Apr 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?
Time of intubation (time frame: 5 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 15 Apr 2022.