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Fiberoptic Tracheal IntubationNCT03173651

The Efficiency of Different Oropharyngeal Airways as a Conduit for Fiberoptic Intubation. Comparative Study

A study testing Modified Williams airway, Modified Guedle's airway and LMA MADgic airway in people with Fiberoptic Tracheal Intubation, run by Kasr El Aini Hospital.

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

60 Patients were randomly allocated into three equal groups, after induction of general anesthesia one of the three airways included in the study (Modified Williams, Modified Gudle's and LMA MADgic airway) was used as a conduit for endotracheal tube placement using fiberoptic bronchoscopy. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Fiberoptic Tracheal Intubation
What is being tested?
Modified Williams airway, Modified Guedle's airway and LMA MADgic airway
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
Jun 2016to May 2017
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 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • ASA physical state I-II Ganzouri airway score less than 4

Who cannot join

  • ASA physical state III-IV. Patients with Ganzouri airway score more than 4. Patients with risk of aspiration of gastric content. Any anatomical abnormalities or iatrogenic injuries that invalidate Ganzouri airway score.

About this study

60 Patients were randomly allocated into three equal groups, after induction of general anesthesia one of the three airways included in the study (Modified Williams, Modified Gudle's and LMA MADgic airway) was used as a conduit for endotracheal tube placement using fiberoptic bronchoscopy. Airway insertion time, ease of insertion, adaptation to oral cavity and intubation time was recorded.

Read the detailed description

The study was conducted in Kasr Alainy hospital, faculty of medicine, Cairo University.

After approval of ethical committee and informed written consent from each patient, 60 patient aging above 18 years, ASA I-II , with Ganzouri airway score <4 and undergoing elective surgeries under general anesthesia were included in the study.

Patients were randomly allocated into three equal groups:

Group M (GM) (n=20 patients): patient was intubated using LMA MADgic airway. Group W (GW) (n=20 patients): patient was intubated using modified Williams airway.

Group G (GG) (n=20 patients): patient was intubated using modified Guedel's airway.

Randomization was performed by random computer allocation with numbered closed opaque envelopes.

The study was performed by expert anesthesiologist in FOB intubation. In the preparation room, all patients was cannulated with a 20 gauge venous cannula and 0.02mg/kg Midazolam was given. Patient transferred to the operating room and was monitored with non-invasive blood pressure, pulse oximetry and ECG. After preoxygenation using a facemask for 5 min, induction of anesthesia was done with 2mg/kg propofol, 1 μg/kg of fentanyl and 0.6 mg/kg of atracurium.

After loss of consciousness the selected airway according to group randomization was inserted into the mouth (size selection and technique of insertion according to manufacturer instruction). Time of insertion defined as the time, in seconds, from touching the patients' mouth with the airway until capnographic confirmation of ventilation by facemask. The ease of insertion was determined by number of attempts of airway insertion. Adaptation of the airway was determined by adequacy of ventilation, fitness to the oral cavity and appearance of successive ETco2 waves.

Manual positive-pressure ventilation was then started with 100% oxygen and 1-1.5% isoflurane through the facemask for 3 min until complete muscle relaxation was confirmed (when train-of-four count becomes zero).

Loaded FOB was inserted for intubation through the airway, laryngeal view grade was recorded (LVG) using Brimacomb and Berry scale; thereafter, the fiberscope was advanced into the trachea to a level just above the carina and the tracheal tube was railroaded over it.

Tracheal intubation could be facilitated by tube rotation, jaw thrust, neck extension or flexion and adjustment of the airway was allawed and was recorded. The intubation time was recorded ; that is, the time from cessation of manual ventilation using a facemask until restarting of ventilation through the tracheal tube.

The airway was removed except the LMA MADgic airway which was removed before ETT insertion. The ease of airway removal was evaluated by the anesthesiologist.

Being tested
Modified Williams airway, Modified Guedle's airway, LMA MADgic airway

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Modified Williams airwayDevice

    Also called Fikrey airway

    This airway used as a conduit for fiberoptic bronchoscopic tracheal intubation in Group W

  • Modified Guedle's airwayDevice

    This airway used as a conduit for fiberoptic bronchoscopic tracheal intubation in Group G

  • LMA MADgic airwayDevice

    This airway used as a conduit for fiberoptic bronchoscopic tracheal intubation in Group M

Study groups in NCT03173651
Study groupRoleWhat they receive
Group WExperimentalThis group was intubated by Fiberoptic bronchoscope assisted by Modified Williams airway as a conduit
Receives: Device: Modified Williams airway
Group GExperimentalThis group was intubated by Fiberoptic bronchoscope assisted by Modified Guedle's airway as a conduit
Receives: Device: Modified Guedle's airway
Group MExperimentalThis group was intubated by Fiberoptic bronchoscope assisted by LMA MADgic airway as a conduit
Receives: Device: LMA MADgic airway

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time of intubation

    The time from cessation of manual ventilation using a facemask until restarting of ventilation through the tracheal tube

    Measured: within 15 minutes from induction of general anesthesia

Secondary outcomes (2)
  1. Time of insertion

    Time from touching the patients' mouth with the airway until capnographic confirmation of ventilation by facemask

    Measured: within 15 minutes from induction of general anesthesia

  2. Laryngeal View Grade

    Degree of vocal cord visualization by fiberoptic bronchoscope

    Measured: within 15 minutes from induction of general anesthesia

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2017
  2. Study startJun 2016
  3. Primary completionApr 2017
  4. Study completionMay 2017

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
Device feasibility
Allocation
Randomised
Intervention model
Crossover
Model description
prospective randomized trial
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03173651
Sponsor's protocol ID
N-40-2016
Status last verified
May 2017
First submitted
27 May 2017
Last updated
2 Jun 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Dina N. Abbas, Ekramey M. Abdghaffar. Comparison of the air-Q intubating laryngeal airway versus the modified Williams intubating airway as aids for training in fiberoptic tracheal intubation. Ain-Shams Journal of Anesthesiology 2013, 6:134-139.

Questions about this trial

What is this clinical trial studying?

A study testing Modified Williams airway, Modified Guedle's airway and LMA MADgic airway in people with Fiberoptic Tracheal Intubation, run by Kasr El Aini Hospital.

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 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: finished, as of the sponsor's last update on 2 Jun 2017. 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?

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: within 15 minutes from induction of general anesthesia). 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 NCT03173651, which also lists 1 linked publication.

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 2 Jun 2017.

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