Flexible Fiberoptic Bronchoscopy Versus Flexible Intubation Video Endoscope FIVE in Obese PatientsNCT03423563
Comparison of Endotracheal Intubation Using Flexible Fiberoptic Bronchoscopy Versus Flexible Intubation Video Endoscope (FIVE) in Obese Patients Undergoing Elective Surgeries Under General Anesthesia: A Randomized Controlled Trial
A study testing Flexible fiberoptic bronchoscopy and Fexible intubation video endoscopy in people with Flexible Fiberoptic Bronchoscopy Versus Flexible Intubation Video Endoscope FIVE in Obese Patients, run by Cairo University at 1 site in Egypt.
Trial summary
Tracheal intubation is one of the most common medical procedures performed in hospitals. On one hand, it is highly successful and easy to perform using a rigid laryngoscope. On the other hand, hypoxic brain damage and death may result rapidly if it is unsuccessful. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Flexible Fiberoptic Bronchoscopy Versus Flexible Intubation Video Endoscope FIVE in Obese Patients
- What is being tested?
- Flexible fiberoptic bronchoscopy and Fexible intubation video endoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Jan 2018to 11 Feb 2018
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 20 and 50 years.
- Scheduled for elective surgery requiring endotracheal intubation.
- Patient with ASA physical status I-II.
Who cannot join
- • Unable to give consent
- Patient with ASA physical status more than II.
- Age < 20years old and >50years
- Pregnant patient.
- Known, difficult airway
- Loose teeth
Show all 9Show fewer
- Require a rapid sequence induction,
- If special endotracheal tube (ETT) is needed for the case.
- Emergency surgeries
Trial locations and contacts
1 site in 1 country.
About this study
Tracheal intubation is one of the most common medical procedures performed in hospitals. On one hand, it is highly successful and easy to perform using a rigid laryngoscope. On the other hand, hypoxic brain damage and death may result rapidly if it is unsuccessful. This disastrous outcome happens when the airway cannot be secured by intubation and face mask ventilation becomes difficult.
Careful preoperative evaluation to identify patients in whom tracheal intubation and mask ventilation may prove to be difficult can save lives.
Read more
Over the past 40 years, different techniques of tracheal intubation have been introduced, the most effective under different conditions being fiberoptic intubation.
The flexible intubation video endoscope is a relatively new device which delivers clear, pixel-free images without a Moiré pattern. The flexible intubation video endoscope can be directly connected to the C-MAC® monitor. Due to the Distal Chip technology the user enjoys a full-format direct video imaging with improved image quality with a resolution higher than fiberoptic bronchoscopy which has another disadvantage of being Fragile where Fibres can be broken or have transmission loss when wrapped around curves of only a few centimeters radius.
After ethics approval and informed consent from patients, 60 obese patients aging from 20-60 years will randomly allocated and divided into two groups each is (Thirty) patients in each group, using flexible intubation video endoscope(FIVE) in (group1) and fiberoptic bronchoscopy in (group 2).
The study will compare the techniques for time of intubation, hemodynamic (SBP, DBP and HR) changes, success rate, number of attempts and complications in both groups.
investigators expect from this study that flexible intubation video endoscope(FIVE) has become a good alternative and associated with better visualization of laryngeal structures in shorter time as compared to traditional flexible fiberoptic bronchoscopy.
Read the detailed description
Airway management is considered a cardinal aspect of anesthetic practice and of emergency and intensive care medicine. Endotracheal intubation is a simple, safe, rapid and nonsurgical method that achieves all the objectives of airway management which include maintaining a patent airway, lung protection from aspiration and allows leak free ventilation during mechanical ventilation. Even though endotracheal intubation isn't a complication free procedure, some of them life-threatening. It is important to anesthesiologists to be alert to these complications and to have an effective plan to avoid and manage these complications when they occur .
If a clear airway can't be guaranteed, it can be fatal. In 1990, an analysis of anesthesia-related closed claims in the USA declared that respiratory system adverse outcomes were the lone largest class of injury and that the percentage of death or catastrophic brain insult associated with it was much higher than that associated with cardiovascular problems.Since then, it became a priority to decrease the serious adverse outcomes associated with airway management; major protocols for difficult airway management have been defined, developing new reliable airway devices, and adequate monitoring of ventilation by pulse oximetry and capnography have become a standard. Thanks to these efforts, the incidence of these serious adverse outcomes is likely to be reduced, and airway management can now be considered as a safe procedure.
Endotracheal intubation is still the "gold standard" in airway management . If with using traditional techniques or video-assisted techniques which can be used when there is intubation failure or anticipated difficult airway. Video-assisted techniques may help to increase intubation success.
Video-assisted techniques allow to indirectly visualize the laryngeal structures with fiber optical or camera chip technique and to show the video picture on an external or built-in monitor.
Fiberoptic intubation has been considered for a long time the gold standard technique for intubation when there is anticipated or known difficult airway or as a rescue device in can't intubate but can ventilate scenarios . Fibreoptic intubation can be a hard skill to teach, gain and keep.In this context, closed claims analysis has declared severe complications such as catastrophic brain insult and death occurred with anticipated difficult airway management and awake intubation. Therefore, it is considerable to develop simple, dependable, safe, and effective intubation devices.
- Conditions
- Flexible Fiberoptic Bronchoscopy Versus Flexible Intubation Video Endoscope FIVE in Obese Patients
- Being tested
- Flexible fiberoptic bronchoscopy, Fexible intubation video endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible fiberoptic bronchoscopyDevice
Flexible fiberoptic bronchoscopy versus flexible intubation video endoscope regarding intubation time in obese patients
Fexible intubation video endoscopyDevice
Fexible intubation video endoscopy
| Study group | Role | What they receive |
|---|---|---|
| Flexible fiberoptic bronchoscopy | Experimental | Fiberoptic intubation has been considered for a long time the gold standard technique for intubation when there is anticipated or known difficult airway or as a rescue device in can't intubate but can ventilate scenarios Receives: Device: Flexible fiberoptic bronchoscopy |
| Fexible intubation video endoscopy | Experimental | Video-assisted techniques allow to indirectly visualize the laryngeal structures with fiber optical or camera chip technique and to show the video picture on an external or built-in monitor Receives: Device: Fexible intubation video endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful intubation
Time in Minutes of successful intubation.
Measured: Intraoperative
Secondary outcomes (2)
Rate of first successful intubation
Rate of first time success intubation
Measured: Intraoperative
Second trial for successful intubation
Intubation success in second trial
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start4 Jan 2018
- Primary completion5 Feb 2018
- Study completion11 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flexible Fiberoptic Bronchoscopy Versus Flexible Intubation Video Endoscope FIVE in Obese PatientsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this prospective randomized controlled study 60 patients with ASA physical status Ӏ-ӀӀ, aging 20-50 years will be randomly allocated into two groups, 30 patients in each group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Mohamed, Ahmed A., M.D., Mai Wedad Ahmed, Norhan Abdelaleem Ali, Magdy Abdelmohsen Elsayed, Atef Kamel Salama
- Responsible party
- Principal investigator, Ahmed Abdalla, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03423563
- Sponsor's protocol ID
- N-68-2016/Ms
- Status last verified
- Mar 2018
- First submitted
- 26 Dec 2017
- Last updated
- 16 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Via scholar Gate
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Endotracheal Intubation Using Flexible Fiberoptic Bronchoscopy Versus Flexible Intubation Video Endoscope (FIVE) in Obese Patients Undergoing Elective Surgeries Under General Anesthesia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03423563
- Acronym / sponsor ID
- N-68-2016/Ms
- Conditions
- Flexible Fiberoptic Bronchoscopy Versus Flexible Intubation Video Endoscope FIVE in Obese Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Mohamed, Ahmed A., M.D., Mai Wedad Ahmed, Norhan Abdelaleem Ali, Magdy Abdelmohsen Elsayed, Atef Kamel Salama
- Study start
- 4 Jan 2018 (actual)
- Primary completion
- 5 Feb 2018 (actual)
- Study completion
- 11 Feb 2018 (actual)
- First posted
- 6 Feb 2018 (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.
Tracheal intubation is one of the most common medical procedures performed in hospitals. On one hand, it is highly successful and easy to perform using a rigid laryngoscope. On the other hand, hypoxic brain damage and death may result rapidly if it is unsuccessful. This disastrous outcome happens when the airway cannot be secured by intubation and face mask ventilation becomes difficult.
Careful preoperative evaluation to identify patients in whom tracheal intubation and mask ventilation may prove to be difficult can save lives.
Over the past 40 years, different techniques of tracheal intubation have been introduced, the most effective under different conditions being fiberoptic intubation.
The flexible intubation video endoscope is a relatively new device which delivers clear, pixel-free images without a Moiré pattern. The flexible intubation video endoscope can be directly connected to the C-MAC® monitor. Due to the Distal Chip technology the user enjoys a full-format direct video imaging with improved image quality with a resolution higher than fiberoptic bronchoscopy which has another disadvantage of being Fragile where Fibres can be broken or have transmission loss when wrapped around curves of only a few centimeters radius.
After ethics approval and informed consent from patients, 60 obese patients aging from 20-60 years will randomly allocated and divided into two groups each is (Thirty) patients in each group, using flexible intubation video endoscope(FIVE) in (group1) and fiberoptic bronchoscopy in (group 2).
The study will compare the techniques for time of intubation, hemodynamic (SBP, DBP and HR) changes, success rate, number of attempts and complications in both groups.
investigators expect from this study that flexible intubation video endoscope(FIVE) has become a good alternative and associated with better visualization of laryngeal structures in shorter time as compared to traditional flexible fiberoptic bronchoscopy.
Detailed description
Airway management is considered a cardinal aspect of anesthetic practice and of emergency and intensive care medicine. Endotracheal intubation is a simple, safe, rapid and nonsurgical method that achieves all the objectives of airway management which include maintaining a patent airway, lung protection from aspiration and allows leak free ventilation during mechanical ventilation. Even though endotracheal intubation isn't a complication free procedure, some of them life-threatening. It is important to anesthesiologists to be alert to these complications and to have an effective plan to avoid and manage these complications when they occur .
If a clear airway can't be guaranteed, it can be fatal. In 1990, an analysis of anesthesia-related closed claims in the USA declared that respiratory system adverse outcomes were the lone largest class of injury and that the percentage of death or catastrophic brain insult associated with it was much higher than that associated with cardiovascular problems.Since then, it became a priority to decrease the serious adverse outcomes associated with airway management; major protocols for difficult airway management have been defined, developing new reliable airway devices, and adequate monitoring of ventilation by pulse oximetry and capnography have become a standard. Thanks to these efforts, the incidence of these serious adverse outcomes is likely to be reduced, and airway management can now be considered as a safe procedure.
Endotracheal intubation is still the "gold standard" in airway management . If with using traditional techniques or video-assisted techniques which can be used when there is intubation failure or anticipated difficult airway. Video-assisted techniques may help to increase intubation success.
Video-assisted techniques allow to indirectly visualize the laryngeal structures with fiber optical or camera chip technique and to show the video picture on an external or built-in monitor.
Fiberoptic intubation has been considered for a long time the gold standard technique for intubation when there is anticipated or known difficult airway or as a rescue device in can't intubate but can ventilate scenarios . Fibreoptic intubation can be a hard skill to teach, gain and keep.In this context, closed claims analysis has declared severe complications such as catastrophic brain insult and death occurred with anticipated difficult airway management and awake intubation. Therefore, it is considerable to develop simple, dependable, safe, and effective intubation devices.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In this prospective randomized controlled study 60 patients with ASA physical status Ӏ-ӀӀ, aging 20-50 years will be randomly allocated into two groups, 30 patients in each group
| Arm | Type | Receives |
|---|---|---|
| Flexible fiberoptic bronchoscopy | Experimental | Device: Flexible fiberoptic bronchoscopyFiberoptic intubation has been considered for a long time the gold standard technique for intubation when there is anticipated or known difficult airway or as a rescue device in can't intubate but can ventilate scenarios |
| Fexible intubation video endoscopy | Experimental | Device: Fexible intubation video endoscopyVideo-assisted techniques allow to indirectly visualize the laryngeal structures with fiber optical or camera chip technique and to show the video picture on an external or built-in monitor |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 20 and 50 years.
- Scheduled for elective surgery requiring endotracheal intubation.
- Patient with ASA physical status I-II.
Key exclusion criteria (9 listed)
- • Unable to give consent
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 |
|---|---|---|
| Flexible fiberoptic bronchoscopyFlexible fiberoptic bronchoscopy versus flexible intubation video endoscope regarding intubation time in obese patients | Device | Flexible fiberoptic bronchoscopy |
| Fexible intubation video endoscopyFexible intubation video endoscopy | Device | Fexible intubation video endoscopy |
Primary outcome
Successful intubation
Time frame: Intraoperative
Time in Minutes of successful intubation.
2 secondary outcomes
Rate of first successful intubation
Time frame: Intraoperative
Second trial for successful intubation
Time frame: Intraoperative
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 16 Mar 2018.
- Individual participant dataSharing planned: No. Via scholar Gate
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 Flexible fiberoptic bronchoscopy and Fexible intubation video endoscopy in people with Flexible Fiberoptic Bronchoscopy Versus Flexible Intubation Video Endoscope FIVE in Obese Patients, 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 3 inclusion and 9 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 16 Mar 2018. 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?
Successful intubation (time frame: Intraoperative). 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 16 Mar 2018.