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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Egypt1 site
  • Ahmed Abdalla Mohamed

    Cairo, 11451

Other trials in Egypt

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.

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 groups in NCT03423563
Study groupRoleWhat they receive
Flexible fiberoptic bronchoscopyExperimentalFiberoptic 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 endoscopyExperimentalVideo-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.

  1. Successful intubation

    Time in Minutes of successful intubation.

    Measured: Intraoperative

Secondary outcomes (2)
  1. Rate of first successful intubation

    Rate of first time success intubation

    Measured: Intraoperative

  2. 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.

  1. First posted6 Feb 2018
  2. Study start4 Jan 2018
  3. Primary completion5 Feb 2018
  4. Study completion11 Feb 2018

Resources

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)
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

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.

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