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.
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.
- Conditions
- Fiberoptic Tracheal Intubation
- 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 group | Role | What they receive |
|---|---|---|
| Group W | Experimental | This group was intubated by Fiberoptic bronchoscope assisted by Modified Williams airway as a conduit Receives: Device: Modified Williams airway |
| Group G | Experimental | This group was intubated by Fiberoptic bronchoscope assisted by Modified Guedle's airway as a conduit Receives: Device: Modified Guedle's airway |
| Group M | Experimental | This 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.
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)
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
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.
- First posted2 Jun 2017
- Study startJun 2016
- Primary completionApr 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fiberoptic Tracheal IntubationStudies 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- prospective randomized trial
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Ahmed Abdallah, Kasr El Aini Hospital
- Investigators
- Sara Ahmed Abdallah, Master, Principal investigator, Kasr El Aini Hospital
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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficiency of Different Oropharyngeal Airways as a Conduit for Fiberoptic Intubation. Comparative Study
- ClinicalTrials.gov ID
- NCT03173651
- Acronym / sponsor ID
- N-40-2016
- Conditions
- Fiberoptic Tracheal Intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 2 Jun 2017 (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.
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.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- prospective randomized trial
| Arm | Type | Receives |
|---|---|---|
| Group W | Experimental | Device: Modified Williams airwayThis group was intubated by Fiberoptic bronchoscope assisted by Modified Williams airway as a conduit |
| Group G | Experimental | Device: Modified Guedle's airwayThis group was intubated by Fiberoptic bronchoscope assisted by Modified Guedle's airway as a conduit |
| Group M | Experimental | Device: LMA MADgic airwayThis group was intubated by Fiberoptic bronchoscope assisted by LMA MADgic airway as a conduit |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA physical state I-II Ganzouri airway score less than 4
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Modified Williams airwayAlso: Fikrey airwayThis airway used as a conduit for fiberoptic bronchoscopic tracheal intubation in Group W | Device | Group W |
| Modified Guedle's airwayThis airway used as a conduit for fiberoptic bronchoscopic tracheal intubation in Group G | Device | Group G |
| LMA MADgic airwayThis airway used as a conduit for fiberoptic bronchoscopic tracheal intubation in Group M | Device | Group M |
Primary outcome
Time of intubation
Time frame: within 15 minutes from induction of general anesthesia
The time from cessation of manual ventilation using a facemask until restarting of ventilation through the tracheal tube
2 secondary outcomes
Time of insertion
Time frame: within 15 minutes from induction of general anesthesia
Laryngeal View Grade
Time frame: within 15 minutes from induction of general anesthesia
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 2 Jun 2017.
- BackgroundDina 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.
- Individual participant dataSharing planned: Undecided
Related trials for Fiberoptic Tracheal Intubation
Recruiting
Comparison of Awake Tracheal Intubation Methods
Airway Management Assessment, Awake Endotracheal Intubation
Not yet recruiting
First Attempt Success in Tracheal Intubation Through Supraglottic Airway Devices Without Fiberoptic Guidance
Airway Management
Recruiting
Comparison of Double-lumen Tube Intubation Between Fiberoptic Bronchoscopy and Video Laryngoscope
One Lung Ventilation in Thoracic Surgery
RecruitingObservational study
Patient Experience of Transoral Versus Transnasal Awake Tracheal Intubation
Airway Management, Fiberoptic Guided Intubation
Recruiting
A Comparative Study Between Laryseal Pro Extraglottic Device and Ambu Aura Gain Laryngeal Mask as a Conduit for Fiberoptic Tracheal Intubation in Pediatric Population
Laryseal Pro and Ambu Aura Gain as Conduits for Fiberoptic Endotracheal Intubation
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.
Sara Ahmed Abdallah, Master principal investigator
Kasr El Aini Hospital
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.